[{"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13782BR\nJob Posting Title Legal Coordinator\nCareer Category Law/Legal\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The candidate will support attorneys in the Development & Regulatory Law Group.\n\nResponsibilities will include managing multiple and/or complex calendars and will involve prioritizing schedules, coordinating travel arrangements, answering phones and making proper referrals; setting up high-level meetings, preparing expense reports, maintaining files, and providing back-up administrative support when the Sr Legal Executive Assistant is out of office as required.\nBasic Qualifications Associate\u2019s degree & 2 years of directly related experience\nOR\nHigh school diploma / GED & 4 years of directly related experience\nPreferred Qualifications Associates degree\n\n5+ years of related experience in legal and administrative functions in support of legal staff\n\nPrior law firm or in-house law department experience\n\nOutlook, Word, PowerPoint and Excel experience including presentation design and spreadsheet skills\n\nMust possess executive level skills and the ability to interface with internal and external contacts.\n\nThe ability to deal with sensitive and confidential information with diplomacy and discretion is required, as well as a high degree of accuracy and attention to detail.\n\nAbility to work in teams is a must.\n\nAbility to multi-task and prioritize work is essential.", "date_new": "2012-05-24 19:05:43", "url": "http://www.amgen.jobs/xml/28931938/job", "country": "United States", "company": "Amgen", "title": "Legal Coordinator", "reqid": "13782BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28931938}, {"country_short": "PTR", "city": "Juncos", "description": "Auto req 15675BR\nJob Posting Title Principal Scientist\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Puerto Rico\nLocation (City) Juncos\nAmgen Job Description SUMMARY\nTo develop projects/programs and contribute to novel experimental strategies and scientific vision. Functions as a\nlead scientific resource with cross-functional impact. Capable of managing and leading scientific projects which may\ninvolve cross functional areas\nFUNCTIONS\n1. Guides the successful completion of major programs by either functioning in a project leadership role or as\nthe lead scientific/technical resource.\n2. Decisions or recommendations impact the ability to achieve functional /departmental objectives.\n3. Provides guidance in the resolution of scientific/technical issues within the function/department.\n4. Works independently and integrates activities with other function/department.\n5. Exercises considerable latitude in determining objectives or assignments within the function /department\n6. Evaluates progress toward goals and achievement of milestones for work group, with limited additional\noversight, may translate evaluation into appropriate action.\n7. Anticipates complex technical problems and develops practical an innovative solutions.\n8. Frequently develops novel processes or approaches to solve problems within a broad discipline within the\nwork group.\n9. Identifies and analyzes factors and trends outside immediate area that impact project or function/department\n10. Frequently introduces or creates new technologies and concepts\n11. Leads teams that contribute to the achievement of department/project/product team objectives\n12. Coaches, motivates and provides career and scientific/technical, advice to colleagues within the\nfunction/department\n13. Communicates and/or presents scientific/technical information formally and informally within area of expertise\nto a diverse set of audiences, including senior management and external scientific community\n14. Applies knowledge of drug discovery and development process to guide functions/departments\n15. Act as scientific/technical expert within the function /department\n16. Leads the development of key scientific/technical comments.\n** Other functions may be assigned.\nBasic Qualifications Doctorate degree and 2 years of directly related experience or Master\u2019s degree and 6 years of directly related\nexperience or Bachelor\u2019s degree and 8 years of directly related experience or Associate\u2019s degree and 10 years of\ndirectly related experience.\nPreferred Qualifications COMPETENCIES/SKILLS\n? Working knowledge of pharmaceutical/biotech processes\n? Familiarity with documentation in a highly regulated environment\n? Ability to operate specialized laboratory equipment and computers as appropriate.\n? Ability to interpret and apply GLPs and GMPs.\n? Able to develop solutions to routine technical problems of limited scope\n? Demonstrated skills in the following areas:\no Problem solving and applied engineering.\no Basic technical report writing\no Verbal communication\n? Demonstrated Skills in the following areas:\no Basic technical presentations\no Personal Organization\no Dealing with and managing change\no Technical (Equipment Specific)\no Analytical Problem Solving\no Computer Literacy\n? Specialized equipment/process expertise\n? Interacts effectively with variety of communication and working styles\n? Ability to independently determine when additional internal resources are required to solve problems\n? Ability to handle multiple projects at one time\n? Demonstrated Skills in the following areas:\no Schedule development\no Facilitation\no Collaboration\no Completion and follow-up\n? Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope\n? Problem solving skills requiring the application of scientific and theory and calculations and creative skills in the development of hypotheses and approach\n? Working knowledge of financial analysis tools\n? Ability to delegate and manage the project work of others\n? Demonstrated Skills in the following areas:\no Negotiation, persuasion and facilitation\no Collaboration\no Project cost development\no Conflict Resolution\no Leadership and teambuilding\n? Management of contractors and vendors\n? Knowledge of theories and principles related to leading edge technologies.\n? Advanced (industry level) technical expert in at least one specialty area.\n? Ability to motivate and communicate visions/missions\n? Demonstrated Skills in the following areas:\no Advanced project management\no Presentations to large groups\no External networking\n? Personnel coaching and development\n\nOther preferred qualifications:\n1) Guides the successful completion of major programs by either functioning in a project leadership role or as the lead scientific/technical resource.\n2) Decisions or recommendations impact the ability to achieve functional /departmental objectives.\n3) Frequently develops novel processes or approaches to solve problems within a broad discipline within the work group.\n4) Coaches, motivates and provides career and scientific/technical, advice to colleagues within the function/department\n5) Demonstrated Skills in the following areas:\no Schedule development\no Facilitation\no Collaboration\no Completion and follow-up\n6) Demonstrated Skills in the following areas:\no Negotiation, persuasion and facilitation\no Collaboration\no Project cost development\no Conflict Resolution\no Leadership and teambuilding\n7) Personnel coaching and development.", "date_new": "2012-05-24 19:03:47", "url": "http://www.amgen.jobs/xml/28931880/job", "country": "Puerto Rico", "company": "Amgen", "title": "Principal Scientist", "reqid": "15675BR", "state": null, "state_short": null, "location": "Juncos, PTR", "uid": 28931880}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15795BR\nJob Posting Title Marketing and Commercial Development Director\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This is a leadership role shaping the long term strategic direction and reputation of Amgen\u2019s Japan and Asia Pacific (JAPAC) Region, and the role has a reporting relationship to the Regional Vice President/ Japan, Asia, Middle East, Africa and Russia. Deep and recent understanding of China and Japan market would be a significant advantage. The role is responsible for managing strategic and commercial elements of the JAPAC\nRegion.\n\nStrategy & Ops responsibilities include:\n\u2022Leads development of Regional Strategic Plan and ensure delivery of regional strategies\n\u2022Work with Region and other functions, e.g., BAI, GVA, to generate deep insights into Regional needs\n\u2022Work with Region and other functions, e.g., Global Marketing, to generate pipeline forecasts\n\u2022Provide commercial assessment of business development opportunities\n\u2022Working with the Region and Finance to manage the Regional P&L\n\u2022Delivers the cross functional work plan for the China entry and launch of Amgen\u2019s products.\n\u2022Develop reports and communications to provide visibility to JAPAC deliverables status to Corporate and internal customers\n\u2022Develop and maintain relationships with external consultants and regional experts\n\nSkills & Experience Utilized in the role\n\u2022Foreign language skills a plus \u2013 Japanese, Mandarin\n\u2022Maintaining an entrepreneurial spirit by making fast, robust and cost-effective decisions\n\u2022Problem Solving and creativity\n\u2022Forecasting\n\u2022Leading & collaborating across the matrix to deliver results\nBasic Qualifications \u2022Doctorate degree & 4 years of directly related experience\nOR\n\u2022Master\u2019s degree & 8 years of directly related years\nOR\n\u2022Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications \u2022MBA or other graduate degree preferred.\n\u2022Consulting background is beneficial\n\u20228 + years of pharmaceutical and/or biotech leadership experience\n\u2022Understanding of Asia Pacific regional requirements\n\u2022Excellent understanding of Amgen organization and culture \u2013 can navigate the company\n\u2022Ability to lead cross-functional teams and projects\n\u2022Track record of producing results and executing under tight deadlines\n\u2022Comfortable with ambiguity\n\u2022Ability to prioritize and resolve business issues\n\u2022Ability to manage and communicate with senior stakeholders\n\u2022Flexible, embraces new professional experiences\n\u2022Highly developed analytical skills\n\u2022Experience planning and executing new product launches", "date_new": "2012-05-24 19:03:31", "url": "http://www.amgen.jobs/xml/28931873/job", "country": "United States", "company": "Amgen", "title": "Marketing and Commercial Development Director", "reqid": "15795BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28931873}, {"country_short": "CAN", "city": null, "description": "Auto req 15811BR\nJob Posting Title Senior Associate, Supply Chain\nCareer Category Supply Chain\nEmployee Subgroup Salaried FT\nCountry (State/Region) Canada\nLocation (City) Mississauga\nAmgen Job Description Position: Senior Associate, Supply Chain\nReports to: Supply Chain Senior Manager\nGrade Level: 4\nStarting: June 2012\nLocation: Mississauga, ON (Head Office)\n\nInternal applicants are required to have a discussion with their current manager regarding intent to apply.\n\nJob Description:\n\nGeneral Accountability\n- Planning & scheduling of commercial goods in Canada in order to achieve seamless service to patients. Administer and manage local commercial inventories working together with our distribution group and 3rd party logistics providers. SAP Lead for item master inputs & metrics reporting. Strong collaboration with local & corporate groups in order to achieve these accountabilities.\n\nSpecific Responsibilities\n- Work with Supply Chain Senior Manager to manage local forecast planning, product supply planning and inventory / scrap planning. Maintain every patient-every-time performance.\n- Prepare monthly product supply files with actual, LE, & budget data. Work with Finance partner on validating planning inputs within Global system. Liaise with Finance on implementing enhanced forecasting techniques to manage submission deadlines to Corporate.\n- Modeling demand variability: Perform regular and ad-hoc depletion simulations, aging analysis and scrap scenarios for existing products & new launches.\n- Performance metrics: Develop and manage performance dashboards to report on SKU Splits tracking, New Product Launches, Forecast Accuracy, & Inventory / Scrap value.\n- Work with distribution group in optimizing inventory plan of Canadian distribution centers.\n- Work with analytics group on forecast scenarios & reporting for commercial products.\n- Active participation in Consensus Forecast & Forecast accuracy meetings.\n- Active participation in Global Inventory meetings to support SAP master data accuracy initiatives.\n- ERP: Responsible for SAP item master inputs & validation to support existing products & new product launches.\n- APO: Responsible for monthly planning inputs in APO aligned with Corporate planning cycles.\nBasic Qualifications Selection Criteria:\n- 3 to 5 years supply chain experience (pharmaceutical industry preferred)\n- Bachelor\u2019s degree \u2013 B.A. or B.Sc.\n- Experience in SAP (Plan to Stock module specifically), APO experience would be an asset or similar enterprise planning systems experience\n- Strong analytical & problem solving skills, Solutions mindset, strong attention to detail\n- Expertise in Microsoft office applications (Excel, Word, Powerpoint), Microsoft Project would be an asset\n- Strong interpersonal & written communications skills\n- High achiever with a keen interest in Supply Chain", "date_new": "2012-05-24 19:02:47", "url": "http://www.amgen.jobs/xml/28931861/job", "country": "Canada", "company": "Amgen", "title": "Senior Associate, Supply Chain", "reqid": "15811BR", "state": null, "state_short": null, "location": "Virtual, CAN", "uid": 28931861}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 8413BR\nJob Posting Title Category Sr Mgr\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Senior Category Manager is responsible for managing the overall sourcing and supplier management process for respective category. The individual is responsible for the category management process: leading the industry analysis to identify leading suppliers and specific industry characteristics; conducting client requirement analysis; developing a cost-effective comprehensive category strategy based on customer and industry analyses; developing global supply plans and developing contracts with new suppliers or renegotiating existing contracts. The Senior Category Manager is responsible for establishing and implementing a sustaining Supplier Relationship Management process with suppliers and internal business partners.\n\nIn addition to strategy development and SRM, the individual will also execute sourcing and supplier selection processes across several Operations related categories. The successful candidate will develop close relationships with both suppliers and business partner groups. The Senior Category Manager may supervise one or more staff.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\n-Master\u2019s degree & 6 years of directly related experience\nOR\n-Bachelor\u2019s degree & 8 years of directly related experience\nOR\n-Associate\u2019s degree & 10 years of directly related experience\nOR\n-High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Preferred 8+ years of experience (including 3-5 years experience with pharmaceutical/biotech preferred) and 3-5 year's strategic sourcing/category management experience.\n\u2022MBA preferred.\n\u2022The successful candidate should have excellent organizational, project management, communication (written and verbal), in-depth supplier/industry analysis knowledge, expertise in supplier and contracts negotiation and extensive knowledge of category management practices and principles.\n\u2022Candidates must possess strong interpersonal skills, financial skills, a high level of client focus and the ability to effectively interface with all levels of management, including executive management.\n\u2022In addition, candidates should have significant experience in leading cross-functional teams, conflict resolution and stakeholder management.\nCategory experience in one or more areas: Capital Construction, Manufacturing Equipment, Facilities management services or Direct Materials", "date_new": "2012-05-24 19:02:24", "url": "http://www.amgen.jobs/xml/28931855/job", "country": "United States", "company": "Amgen", "title": "Category Sr Mgr", "reqid": "8413BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28931855}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15737BR\nJob Posting Title Finance Sr Manager -- IT Vendor Management Office\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role reports into the lead of the Vendor Management Office VMO Lead, is an integral part of the overall Service Management and Governance (SM&G) team, and a resource for team members for pricing, new work, extensions of scope, and other financial analysis.\n\nThe Finance Sr Manager is accountable for assuring the accuracy and audit ability of all financial transactions related to the outsourced IT environment, and to make certain the proper financial controls are in place for the term of the agreement. This role is responsible for establishing and coordinating all SM&G organization budgets and reviews of business cases for business unit IT projects to ensure financial viability. The Finance Sr Manager is accountable to ensure accuracy of all Service Provider charges, retained expenses and pass-through expenses. The Finance Sr Manager is responsible for providing regular IT financial reporting, including budgeted vs. actual expenses, forecasts, and financial trend analysis.  The Finance Sr Manager is also responsible for ensuring that the appropriate investigation and validation processes are established to handle financial variances in forecasted expenses or usage.\n\nThe Finance Sr Manager will also work with other SM&G team members and lead or participate in such activities as: contract negotiations, vendor reviews, special projects, benchmarks and audits, root cause analysis and other assignments as needed.\n\nThis position works closely with the Contract Management Sr Manager, Contract Executive, other IT organizations and key Service Providers to ensure overall operational excellence and customer satisfaction.\n\nProvides direction and leadership to ensure that proper financial controls are in place for the term of the contract.\n- Establishes and maintains consistent methodologies for performing financial business reviews on effectiveness of the Service Provider relationship\n- Ensures compliance with GAAP and Client\u2019s internal accounting policies\n- Ensure compliance with tax laws\n- Ensure SOX control framework implemented and continuously reviewed if applicable\n- Ensure Service Provider implementation of required SOX controls if applicable\n\nDevelops, administers, controls and optimizes total cost of sourcing in line with the business and sourcing targets:\n- Plans and manages budget/ forecast\n- Investigates and resolves variances in forecasted expenses or usage\n- Manages variance in planned expenses or resource usage\n- Controls global sourcing budget and manages financial data and reporting\n- Manages any global special project budget in conjunction with the Sourcing Executive\n\nEnsures accuracy of all contract-related charges\n- Monitors and audits all monthly charges to ensure accuracy of Service Provider charges, Client-retained expenses, and pass-through expenses\n- Investigates and resolves discrepancies\n\nEnsures timely payment of Service Provider invoices\n- Establishes and maintains the charge-back process and system\n- Ensures timely and accurate payment of Service Provider invoices\n- In conjunction with the Service Management & Governance Executive and Contract Manager, ensures identification and collection/payment of any performance credits or other sums due/payable\n- Manages and controls the financial implications of contractual obligations\n\nProvides direction and support in the financial aspects of contract negotiations\n- Ensures overall effectiveness of the financial side outsourcing efforts\n- Serves as the liaison between outsourcing organization and other corporate entities on finance-related outsourcing issues\n- sures compliance with corporate policies and reporting requirements\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree or & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor Degree in Accounting/Finance\n\nEight years of financial accounting experience\n\nMBA/CPA certification\n\nThorough understanding of Outsourcing Services Agreements, Financial Analysis, Cost Accounting, Cost Models, Cost Allocation processes, and Economics\n\nUnderstanding of IT services such as computer/infrastructure services and telecommunications services; pricing models, and resource units (measures of service utilization)\n\nFinancial and Process skills; an understanding of the company's financial practices and goals \u2013 including drivers of process costs, ability to work with supplier to ensure effective cost solutions and agreed upon service level agreements\n\nKnowledge of Business Unit\u2019s business environment, service requirements and culture\n\nDemonstrated ability to manage a large budget and exercise fiscal responsibility\n\nDemonstrated ability to assess needs, creatively approach solutions, decide and influence appropriate courses of action.\n\nStrong persuasion and problem resolution skills\n\nService provider/vendor management experience\n\nStrong verbal and written communication skills with the ability to articulate complex ideas in easy to understand business terms to senior leaders\n\nStrong collaboration and partnering skills\n\nWorking knowledge of applicable Sarbanes-Oxley regulations\n\nWorking knowledge of any other biopharmaceutical industry", "date_new": "2012-05-23 18:45:31", "url": "http://www.amgen.jobs/xml/28892005/job", "country": "United States", "company": "Amgen", "title": "Finance Sr Manager -- IT Vendor Management Office", "reqid": "15737BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28892005}, {"country_short": "GBR", "city": "Cambridge", "description": "Auto req 15797BR\nJob Posting Title Associate Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Cambridge\nField Based\nUxbridge\nAmgen Job Description This role provides regular and ad-hoc financial, accounting, and analytical support. Responsibilities may include supporting various levels of Finance Managers and Revenue and Expense Analysts on tasks such as the monthly close, monthly forecasting, and ad-hoc projects related to our overall business. Additional responsibilities may include financial modeling, analysis of Finance spending, preparation and presentation of financial materials, variance analysis and special projects.\nBasic Qualifications Associate\u2019s degree & 4 years of experience directly related to the job OR High school diploma / GED & 6 years of experience directly related to the job\nPreferred Qualifications \u2022 Strong communication skills \u2022 Excellent organizational skills and detail oriented \u2022 Ability to use Microsoft Word, Excel, and Power Point \u2022 Able to multi-task and stay focused on priorities in a fast paced environment to meet deadlines \u2022 Strong team player who is able to collaborate with colleagues on complex tasks \u2022 Prior work experience a plus \u2022 Biotechnology, pharmaceutical or healthcare industry experience is a plus but not required", "date_new": "2012-05-23 18:45:28", "url": "http://www.amgen.jobs/xml/28892002/job", "country": "United Kingdom", "company": "Amgen", "title": "Associate Finance", "reqid": "15797BR", "state": null, "state_short": null, "location": "Cambridge, GBR", "uid": 28892002}, {"country_short": "SWE", "city": "Stockholm", "description": "Auto req 15747BR\nJob Posting Title Sr Associate BAI\nCareer Category Sales & Marketing Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) Sweden\nLocation (City) Stockholm\nAmgen Job Description As a member of the BPA team,\nEnsure technical sustainability for Sales Reporting\nSupport and ensure utilization and adherence of the N&B DWS model , local cubes and dashboards\nEnsure uniform standards and consistency in N&B Sales models .\nSupport and operational implementation of approved models or tools in N&B Region\n\nAs a member of the Sales Force Effectiveness team\nSupport to Activity reporting , target setting and SIP reporting\nSupport and ensure utilization and adherence of the N&B Activity, Target setting and SIP models\nEnsure uniform standards and consistency in N&B SFE models .\n\nAs a member of the SME team\nEnhance and develop other N&B SME models\nSupport and enhance any system requirements.\nProcesses and analyzes internal and external data sources.\nCoordinates with IS/COE to implement systems and processes initiated on both a European, Regional and an affiliate level.\nSupport maximization and utilization of the available primary and secondary data sources/systems in support of audience/product.\nAny ad-hoc analysis required\nBasic Qualifications Minimum requirements\n- Academic education or experience from similar positions\n- Demonstrated excellence in Excel and data bases management\n- Technically excellent in analytical disciplines\n- Technically excellent in Excel and data management and analytical tools.\n- Experience in the Pharmaceutical industry\nExperience in project management\nKnowledge of the pharmaceutical business\n- Project/project manager of new models development\n- Experience of system support and development in cross-functional environments\n- Fluency in English, both in oral and written communication\nPreferred Qualifications - Experience as consultant/advisor\n- Experience of N&B co-operation\n- Experience of working with advance Excel and tools/models/ systems development\n- University Degree (data and/or engineering)\n- >2 year Industry/pharmaceutical knowledge\n- Analytical and Technical skills to develop tools, models and analysis for business and management, and be able to continually evaluate and improve our current tools\n- Knowledge and ability to work well with Excel, data bases in system interfaces\n- Strong numerical skills and creative problem solver\n- Ability to champion ideas and projects\n- Good Interpersonal skills to interact with internal customers\n- Leadership skills with knowledge and ability to work well within a matrix environment and teams\n- Project management skills - planning, prioritization, meeting management, project management and plan execution\n- Communication skills with an ability to efficiently and productively communicate both orally and in writing at all levels\n- Demonstrates behavior consistent with Amgen\u2019s Values\n- Business professional with capacity to grow and learn, self aware, emotionally intelligent", "date_new": "2012-05-23 18:45:01", "url": "http://www.amgen.jobs/xml/28891992/job", "country": "Sweden", "company": "Amgen", "title": "Sr Associate BAI", "reqid": "15747BR", "state": null, "state_short": null, "location": "Stockholm, SWE", "uid": 28891992}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15742BR\nJob Posting Title Contract Management Sr Manager -- IT Vendor Management Office\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role reports into the Vendor Management Office Lead, works with the Various IS Operational leads and the Governance Services Team and is ultimately responsible for a contract or given set of contracts. This person acts as the one escalation point for any issues related to the contract(s) they are assigned. In addition this person is responsible for the overall relationship and performance of the Service Providers.\n\nThe Contract Management Sr Manager is accountable for managing all aspects of the client\u2019s contractual agreement(s) with the Service Provider on behalf of the client and client business units. The Contract Principal works in close collaboration with Governance Services (ISG), Legal, ISGS, Service Delivery and Finance to: maintain a thorough knowledge of all aspects of the contract; modify the contract as needed; educate client leadership on the client\u2019s and the Service Provider\u2019s obligations within the overall agreement; report on the status of these obligations; manage issues related to the contract; and assist in interpreting the contract as needed. The Contract Principal will also work with ISG on negotiating amendments to the Contract. In cases where contract terms are in dispute between the client and the Service Provider, this role is the subject matter expert advocate for the client.\n\nThe Contract Management Sr Manager:\n\nManages overall compliance with contractual terms & conditions with the support of ISG:\n- Develop tools to support the Service Delivery and Governance teams, specifically the Deliverables & Obligations trackers, and refresh these as the contract evolves over time\n- Develops a Deliverables & Obligations Tracker, establishes a process for D&O tracking, assigns D&O responsibilities and manages the client and Service Provider compliance with obligations on an ongoing basis\n- Monitor and maintain the Service Provider and Client\u2019s compliance with contract terms and conditions, commitments and notifications\n- Manages the end-to-end Supplier Audit process; ensures that appropriate audit controls are in place for Service Provider\u2019s processes and invoices, in accordance with the process established in the Client\u2019s Policy & Procedures Manual\n- Potentially manages Service Provider exit\n\nGuards the relationship with the Service Provider with support of ISG:\n- \"Guards and owns the integrity of the pricing schedules and mechanisms and ensure they are fit for purpose\"\n- Evaluate Performance Credits and approve any action plans resulting from critical service performance failures\n- Manages any re-pricing making use of existing contractual mechanisms for cost/price change\n\nIs responsible for contract maintenance with the support of ISG:\n- Manages the end-to-end lifecycle process of Contract Change from development through to execution, including obtaining the relevant stakeholder approvals;\n- Initiation + preparation of change request\n- Impact assessment and prioritization\n- Final approval\n- Physical update of contract\n- Evaluates innovation gain sharing mechanisms, and assures their alignment with the agreed-upon principles of innovation\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree or & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor\u2019s plus Eight years developing and managing contracts, procurement or other sourcing experience\n\nUnderstanding of IT services such as computer/infrastructure services and telecommunications services\n\nExtensive experience with negotiation with third parties\n\nExcellent verbal and written communication skills \u2013 with various levels of organization\n\nChange management and facilitation skills\n\nProven ability to manage the development, implementation and ensure adherence to processes\n\nPeople management and collaboration skills\n\nFirm but fair mindset\n\nWorking knowledge of any other biopharmaceutical industry", "date_new": "2012-05-23 18:44:37", "url": "http://www.amgen.jobs/xml/28891970/job", "country": "United States", "company": "Amgen", "title": "Contract Management Sr Manager -- IT Vendor Management Office", "reqid": "15742BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28891970}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15785BR\nJob Posting Title Scientific Director - Comparative Biology & Safety Sciences\nCareer Category Preclinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen is seeking an experienced drug development scientist to provide leadership and mentorship to the department and actively contribute in the drug development process from target selection and lead optimization through product registration. Working in a collaborative team environment with other colleagues in Research and Translational Sciences (e.g. therapeutic area scientists, drug metabolism, chemistry, protein sciences, early clinical development), the incumbent will contribute to the selection and safety assessment of small molecule and biologic therapeutics and represent Comparative Biology & Safety Sciences (CBSS) on drug development teams within Amgen. Amgen scientists make significant contributions, work in multiple therapeutic areas, and mentor and motivate their colleagues.\nAs a Scientific Director in CBSS, you will design, implement, analyze and integrate a wide range of datasets from investigative studies and nonclinical safety assessment programs in support of drug discovery, lead optimization and drug development. Experience in resolving nonclinical safety issues through the establishment of novel protocols to solve experimental questions, in addition to devising strategies and planning activities to achieve project goals is required. An understanding of cutting-edge science and technology employed to enhance investigation of drug development safety liabilities is needed. You will participate and contribute to key project teams and provide regular updates as appropriate to senior management. You will be asked to mentor other colleagues and to contribute your expertise in the peer-review of plans and work products emerging from the department. Opportunities exist to serve as a leader for cross-functional CBSS teams focused on new initiatives, in-licensing, and emerging strategies.\nBasic Qualifications Doctorate degree & 7 years of directly related experience\nOR\nMaster\u2019s degree & 13 years of directly related experience\nOR\nBachelor\u2019s degree & 15 years of directly related experience\nPreferred Qualifications A D.V.M., M.D. and/or a Ph.D in a biological science with expertise in a specific disease discipline, comparative medicine or pathology highly preferred.\nA minimum of a combined 10 years experience of academic and industry experience in nonclinical drug development demonstrating a sustained record of achievement.\nExperience is needed to critically evaluate and interpret integrated sets of data from scientific experiments and then translate the potential clinical impact.\nExcellent verbal and written communication skills are necessary as the incumbent will contribute to appropriate sections of regulatory documents.\nAdditional abilities expected include managing conflict, prioritization skills, resilience, and the demonstration of leadership through proactivity and influence, especially in a team environment.\nPost-doctoral research experience in toxicology, pathology or a disease specialty area.\nBoard certification in toxicology or pathology.\nThe preferred candidate will also have a working knowledge of computational and database tools for assessing multi-dimensional data and an ability to effectively query the literature and other public domain data repositories.\nThe ability to work independently and to build productive cross-functional collaborations both internally and externally is also preferred.", "date_new": "2012-05-23 18:44:03", "url": "http://www.amgen.jobs/xml/28891955/job", "country": "United States", "company": "Amgen", "title": "Scientific Director - Comparative Biology & Safety Sciences", "reqid": "15785BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28891955}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15768BR\nJob Posting Title Sr Project Mgr\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\n\nThe Sr. Project Manager provides project management support & leadership to PST sub-teams, sub-team projects and subprojects and is accountable to the Global Project Manager, Product Strategy Team & / or Research team leaders, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects.\n\nKey Responsibilities\n\n- Team Leadership- Provide operational leadership in team and/or sub-team meetings and identify cross-functional implications, risks and issues. Elevate sub-team issues and work to overcome implementation obstacles at the functional level. Ensure strategic alignment between sub-teams and PST / Research project teams. Drive effective sub-team operations, including goal setting, sub-team charters, functional mgmt reviews, etc. and ensure that all goals and objectives are well understood by the various functional areas.\n\n- Cross Functional Communication- Provide timely, accurate communication between teams / sub-teams and functional departments. Communicate appropriate information on functional team status & issues to stakeholders.\n\n- Strategic Thinking - Actively participate in all PST sub-team team discussions and ensure all views are heard. Assist teams and sub-team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan. Coordinate with the teams and the sub-teams to ensure sub-team plan alignment with the Project strategic plans.\n\n- Risk Management- Conduct functional team-level risk assessment and scenario planning to support sub-team issues. Proactively drive development of contingency and/or risk-mitigation plans at the sub-team level.\n\n- Resource Planning- Provide information to assist with resource planning at the sub-team level and elevate resource issues as needed. Identify and reconcile resource issues across sites or functions that may impact global coordination.\n\n- Project Management Process- Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate sub-team plans into actionable and measurable tasks. Follow up on action items from sub-team meetings. Establish and achieve project standards for work quality and quantity.\n\n- Product Team Deliverables- Ensure adherence to Commercialization and governance processes at the sub-team level. Assist in the development/update of key Commercialization sub-team deliverables, e.g., sub-team plans, etc. Generate periodic updates and/or prepare formal presentations to line managers and/or others for all management reporting. Provide detailed data support for portfolio management/DA processes. Drive the development of functional plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - Project Management Professional(PMP) certification desired.\n- MBA or PhD\n- 7 or more years of experience in cross-functional clinical development project teams and/or experience with project management practice within the pharmaceutical industry\n- Experience working on Phase 3 or marketed product development", "date_new": "2012-05-23 18:43:55", "url": "http://www.amgen.jobs/xml/28891953/job", "country": "United States", "company": "Amgen", "title": "Sr Project Mgr", "reqid": "15768BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28891953}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 15730BR\nJob Posting Title Sr Associate QA\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nAmgen Job Description Objective\n- To provide QA guidance and support in the production area at Amgen Breda\n- To perform batch record review of batches assembled, packaged and labeled and contract manufacturers.\n- To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person\n\nPosition Specific tasks:\n- Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.\n- Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.\n- Review and approve batch production record data entries before production activities take place\n- Perform finished product checks during (commercial) production runs\n- Compile and review batch records for lots assembled, packaged and labeled and contract manufacturers in preparation for disposition by Qualified Person.\n- Act as author for operational SOP\u2019s and Work Instructions\n- Review of operational SOP\u2019s and Work Instructions\n- Review and approve class I Non Conformances\n- Initiate and own QA Non Conformances as needed.\n\nIn this job you work in 3 shifts (including night shifts)\nBasic Qualifications - MBO or Bachelor\u2019s degree in Life Sciences or related field or the equivalent combination of education and/or experience.\n- Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.\n- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.\n- Manufacturing and/or Quality analytical processes and operations.\n- Fluent in English language.\nPreferred Qualifications - Fluent in Dutch language", "date_new": "2012-05-22 19:48:28", "url": "http://www.amgen.jobs/xml/28868677/job", "country": "Netherlands", "company": "Amgen", "title": "Sr Associate QA", "reqid": "15730BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 28868677}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15752BR\nJob Posting Title Marketing Sr Mgr, Nephrology\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Manages the development and execution of marketing strategies and tactics for Aranesp\u00ae Nephrology and Aranesp\u00ae Oncology in the Hospital and Epogen\u00ae. This position uniquely partners across both the NBU and OBU.\n\nResponsibilities:\n\n1. Leads cross-BU marketing for Aranesp in the Hospital (NBU and OBU).\n2. Develops and executes the brand campaign, messages and tactical plans within a competitive environment (personal and non-personal).\n3. Develops ESA-Nephrology patient resources.\n4. Lead for congresses, commercial advisory boards and engagement with Nephrologists and Pharmacists.\n5. Develops brand sales training programs and materials with Sales Training teams\n6. Adapts brand tools and messages for use on digital platforms\n7. Manages day-to-day operations of agency and vendors\n8. Manages program budgets\n9. Leads and coordinates market research for tools and programs with BAI\n10. Develops metrics for program and tool effectiveness with BAI\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 MBA in business or masters in health sciences or additional education in biology, chemistry, life sciences\n\u2022 2+ years in oncology or nephrology pharmaceutical / biotech hospital sales\n\u2022 2+ years of pharmaceutical or biotech industry experience with focus on developing and/or executing market strategies and tactics\n\u2022 Knowledge of nephrology, oncology, cardiology, endocrinology, or related disease model desired\n\u2022 Successful track record of increasing responsibility within marketing or sales\n\nCompetencies/Skills:\n\n\u2022 Strategic and tactical planning: demonstrated ability to analyze a business problem, develop an appropriate strategy, and implement effective tactics\n\u2022 Customer insights: ability to collaborate with internal and external groups and gain customer and patient insights\n\u2022 Brand Value\n\u2022 Commercial execution\n\u2022 Sales force engagement\n\u2022 Communication skills, written and oral\n\u2022 Matrix Management\n\u2022 Strong analytical and research skills\n\u2022 Project management: ability to set targets, track to milestones, and complete projects\n\u2022 Requires a thorough understanding of the legal and regulatory environment in pharmaceutical promotions and reimbursement.", "date_new": "2012-05-22 19:48:19", "url": "http://www.amgen.jobs/xml/28868665/job", "country": "United States", "company": "Amgen", "title": "Marketing Sr Mgr, Nephrology", "reqid": "15752BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28868665}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15758BR\nJob Posting Title Sr Project Mgr - Product Strategy Team\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\n\nThe Sr. Project Manager provides project management support & leadership to PST sub-teams, sub-team projects and subprojects and is accountable to the Global Project Manager, Product Strategy Team & / or Research team leaders, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects.\n\nKey Responsibilities\n\nTeam Leadership - Provide operational leadership in team and/or sub-team meetings and identify cross-functional implications, risks and issues. Elevate sub-team issues and work to overcome implementation obstacles at the functional level. Ensure strategic alignment between sub-teams and PST / Research project teams. Drive effective sub-team operations, including goal setting, sub-team charters, functional mgmt reviews, etc. and ensure that all goals and objectives are well understood by the various functional areas.\n\nCross Functional Communication - Provide timely, accurate communication between teams / sub-teams and functional departments. Communicate appropriate information on functional team status & issues to stakeholders.\n\nStrategic Thinking - Actively participate in all PST sub-team discussions and ensure all views are heard and aligned. Assist teams and sub-team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan. Coordinate with the teams and the sub-teams to ensure sub-team plan alignment with the Project strategic plans.\n\nRisk Management - Conduct functional team-level risk assessment and scenario planning to support sub-team issues. Proactively drive development of contingency and/or risk-mitigation plans at the sub-team level.\n\nResource Planning - Provide information to assist with resource planning at the sub-team level and elevate resource issues as needed. Identify and reconcile resource issues across sites or functions that may impact global coordination.\n\nProject Management Process - Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate sub-team plans into actionable and measurable tasks. Follow up on action items from sub-team meetings. Establish and achieve project standards for work quality and quantity.\n\nProduct Team Deliverables - Ensure adherence to Commercialization and governance processes at the sub-team level. Assist in the development/update of key Commercialization sub-team deliverables, e.g., sub-team plans, etc. Generate periodic updates and/or prepare formal presentations to line managers and/or others for all management reporting. Provide detailed data support for portfolio management/DA processes. Drive the development of functional plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan.\nBasic Qualifications Doctorate degree and 2 years of directly related experience\nOR\nMaster\u2019s degree and 6 years of directly related experience\nOR\nBachelor\u2019s degree and 8 years of directly related experience\nOR\nAssociate\u2019s degree and 10 years of directly related experience\nOR\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications - Demonstrated experience in project management, business analysis, or managing and/or coordinating domestic and/or international product development\n\n- Project Management Professional (PMP) certification desired\n\n- MS, MBA or PhD\n\n- 7 or more years of experience in cross-functional pharmaceutical development project teams and/or experience with project management practice within the pharmaceutical industry\n\n- Experience working on late stage product development\n\n- Experience working on BLA/NDA regulatory filing activities\n\n- Experience in oncology drug development\n\n- Experience in preparing for product launch\n\n- Excellent verbal and written skills", "date_new": "2012-05-22 19:47:52", "url": "http://www.amgen.jobs/xml/28868639/job", "country": "United States", "company": "Amgen", "title": "Sr Project Mgr - Product Strategy Team", "reqid": "15758BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28868639}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15741BR\nJob Posting Title Sr Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Serve as a technical expert on a drug product team to support commercialization and trouble shooting of manufacturing process. Activities will pertain to process design, scale-up, characterization and technology transfer of drug product manufacturing operations for validation and registration of protein parenteral products.\n\nThe responsibilities include designing and executing bench and pilot scale experimentation, applying sound scientific theory to experimental work, and optimizing various unit operations including protein freeze/thaw, ultrafiltration/diafiltration, formulation, sterile filtration, mixing, vial and syringe filling and lyophilization. Also conducts experiments, analyzes data, writes technical reports and assessments, and communicates frequently with management and team members. She/he serves as a reliable technical resource for clinical manufacturing support and scale-up of drug product operations for commercial production. The candidate will need to participate in cross-functional teams and work effectively in a highly matrixed team environment.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or Life Sciences with a pharmaceutical, vaccine, or biotechnology background with 3 + years experience in biotech/pharmaceutical industry.\n\u2022 Experience with formulation and filling process steps of cryopreservation, lyophilization, vial and syringe filling, sterile filtration, and aseptic processing is preferred.\n\u2022 Experience with statistical analysis, design of experiments, and writing/reviewing technical and manufacturing documents.\n\u2022 Experience with process development for Phase I \u2013 III biologic drug products.\n\u2022 Travel may be required.", "date_new": "2012-05-22 19:47:29", "url": "http://www.amgen.jobs/xml/28868627/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer", "reqid": "15741BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28868627}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15616BR\nJob Posting Title Feasibility & Patient Recruitment Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Manager, Feasibility & Patient recruitment will establish strategies and decision making processes to address the barriers in reaching goals around feasibility and identifying and recruiting appropriate patient populations within established timelines. There are many responsibilities associated with this role key to ensuring the timely and effective delivery of Amgen\u2019s strategy to its stakeholders including: setting project timelines and priorities based on study objectives and ongoing assignments; organizing and leading cross-functional meetings to develop and execute the enrollment forecasting strategies for our programs; identifying patient profiles, patient market dynamics, potential recruitment barriers, regional recruitment boundaries, triggers, contingency plans and implementation plans by country and site. Additionally, this individual will serve as a consultant and advisor to study teams and regions to help them maximize their enrollment rates. He/She will also gather historic regional performance data, track and report successes of various recruitment strategies and manage the inventory of recruitment tools and recruitment vendors and communicate best practices to teams and site management staff ensuring accurate and timely information exchange between departments. Also critical to the success of this role, will be maintaining therapeutic knowledge of Amgen products; knowledge of performance measurement at a departmental level and a fundamental understanding of the organizational change management process.\nBasic Qualifications ?Doctorate degree\nOR\n?Master\u2019s degree & 3 years of directly related experience\nOR\n?Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Advanced Degree preferred\n- Excellent communication, organizational, and interpersonal skills\n- Ability to plan and work on projects with minimal supervision\n- Effective at working with colleagues from all departments and organizational levels while meeting commitments.\n- Experience working as a member of global drug development teams preferred\n- Previous management experience of direct reports or clinical projects\nProven experience in a pharmaceutical environment\n- Good experience of biopharmaceutical clinical research\n- Experience involving a broad exposure to biopharmaceutical clinical development process and procedures\n- Experience developing and implementing recruitment and retention plans\n- Experience working independently across departments within a team/matrix environment\n-Detailed knowledge of international clinical research and drug development\n- Strong understanding of program and study operations in an international setting\n-Relevant therapeutic area(s)\n- Strong computer literacy, including word processing, presentation, spreadsheet and project management applications\n- Organizational change management process", "date_new": "2012-05-21 18:12:39", "url": "http://www.amgen.jobs/xml/28833051/job", "country": "United States", "company": "Amgen", "title": "Feasibility & Patient Recruitment Mgr", "reqid": "15616BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833051}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15637BR\nJob Posting Title Associate Manufacturing\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Under general supervision, performs manufacturing unit operations according to Manufacturing Procedures (MPs) and Standard Operating Procedures (SOPs).\n\nSpecific Job Duties:\nThis is a production floor position supporting fermentation and or purification unit operation execution.\n- Use understanding of process theory to perform and monitor critical processes.\n- Perform routine manufacturing operations and operate equipment in the manufacturing area.\n- Execute routine validation protocols.\n- Set-up, clean, and sanitize labware and equipment.\n- Prepare media and/or buffers and other process materials.\n- Recognize & accurately report problems.\n- Generate and own class 1 non-conformances.\n- Participate in resolving problems during operations.\n- Document activities as appropriate (i.e., MPs and logs) using Good Documentation Practices (GDPs).\n- May draft and revise documents (e.g., SOPs).\n- Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records).\n- Comply with and reinforce cGMPs and safety requirements.\nBasic Qualifications \u2022 Bachelor\u2019s degree\nOR\n\u2022 Associate\u2019s degree & 4 years of directly related experience\nOR\n\u2022 High school diploma / GED & 6 years of directly related experience\nPreferred Qualifications - Bachelor\u2019s degree in Science or Engineering and 3 years experience in a biotech/pharma manufacturing environment or /manufacturing support role (i.e. laboratories, engineering, utilities/facilities, quality).\n- Ability to assemble, disassemble, operate, and understand complex equipment per procedures.\n- Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).\n- Ability and willingness to work any day, swing, or grave shift in support of operations that may include 24/7.\n- Ability to understand, apply, and evaluate basic chemistry, biology and physical principles as appropriate for the position.\n- Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.\n- Documentation skills.\n- Written and oral communication skills. Proficiency in reading and writing English.\n- Basic problem solving skills.\n- Ability to lift 30 lbs.", "date_new": "2012-05-21 18:12:07", "url": "http://www.amgen.jobs/xml/28833041/job", "country": "United States", "company": "Amgen", "title": "Associate Manufacturing", "reqid": "15637BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833041}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15634BR\nJob Posting Title Compliance Sr Mgr, Global Privacy and Data Protection, Policies, Training and Communication\nCareer Category Compliance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Experienced Privacy Professional to work in the Worldwide Compliance and Business Ethics Department of a global pharmaceutical/biotechnology company (Company\u201d) located in Southern California. The individual will report directly to the Chief Privacy Officer and will:\n\n\u2022 Develop, lead and continuously improve, in collaboration with the Chief Privacy Officer, programmatic efforts designed to build effective global and cross-functional privacy and data protection controlled documents (including policies, procedures, templates and forms), training and communication in a manner conducive to the success of the business\n\u2022 Develop and maintain a multi-year plan outlining the strategy for development and execution of global and cross-functional privacy and data protection-related controlled documents, training and communication\n\u2022 Anticipate project challenges, troubleshoot, problem solve, recommend solutions\n\u2022 Author, update, maintain and serve as subject matter expert on privacy and data protection-related controlled documents, working objectively to analyze compliance issues or concerns\n\u2022 Develop and design comprehensive long-term sustainable role-based training curricula for privacy roles globally\n\u2022 Serve as a subject matter expert on both policy and training content for targeted and company-wide privacy and data protection-related training courses\n\u2022 Provide official interpretation of privacy and data protection-related controlled documents to stakeholders, as warranted, including the preparation of official clarifications or guidance documents based on appropriate inputs (such as legal, regulatory, and business inputs)\n\u2022 Perform research on privacy and data protection-related laws, regulations, and industry developments and interpret their impact on Company\u2019s business practices and policies\n\u2022 Engage with attorneys to ensure that privacy and data protection-related controlled documents, training and communication efforts meet legal and regulatory expectations and are implemented to support identified needs\n\u2022 Collaborate with local and international colleagues to develop appropriate and usable global and regional controlled documents, training and communications\n\u2022 Respond to Audit and Investigations findings by determining appropriate privacy and data protection-related actions based on audit requirements\n\u2022 Annually assess controlled documents and training to determine what revisions are warranted\n\u2022 Own and manage projects and reporting on progress, obstacles, and execution\n\u2022 Manage the ongoing revisions of controlled documents\n\u2022 Issue and track the issuance of controlled documents, both internally and with vendors and external service providers\n\u2022 Benchmark our privacy and data protection-related policies and training against those of our peers\n\u2022 Represent Global Privacy Office on corporate cross-functional working teams\n\u2022 Support the global privacy and data protection needs of Company\u2019s Global Operations and Manufacturing function\n\u2022 Prepare for and deliver regular management reviews and operating reviews\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Responsibility for developing and implementing global, cross-functional policy, training and communications initiatives, including creation of global annual and multi-year plans\n\u2022 2+ years of relevant privacy experience at a law firm or global company\n\u2022 Strong working knowledge of global privacy and data protection laws and regulations\n\u2022 Substantial experience building and/or implementing global and cross-functional policy, training and communication efforts including annual/multi-year planning (global experience preferred)\n\u2022 Strong strategic thinking skills and ability to translate strategy into action plans\n\u2022 Excellent ability to interact and build relationships at all levels of management and staffing across organizational/jurisdictional boundaries\n\u2022 Ability to understand, plan and navigate in a matrix environment\n\u2022 Excellent project management skills\n\u2022 Excellent command of English (spoken and written) and public-speaking skills\n\u2022 Availability in crisis\n\u2022 Understanding of global aspect of position\n\u2022 Strong working knowledge of SharePoint, EDMQ and Articulate software and instructional design\n\u2022 Self-starter with a high level of initiative and strong work ethic\n\u2022 Significant experience working with senior management, including both internal and external law departments\n\u2022 Meaningful ability to effectively and timely manage multiple initiatives and cross-departmental projects (i.e., strong project management skills).\n\u2022 Proven ability to multi-task, thrive and deliver in a highly-regulated and increasingly-demanding matrixed corporate environment. Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on an evolving corporate and regulatory landscape. Ability to deal well with ambiguity and complex situations.\n\u2022 Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude.\n\u2022 Strong knowledge of applicable global privacy and data protection laws and regulations as well as ability to perform research to identify and interpret such laws and regulations.\n\u2022 Demonstrable political acumen to collaborate, drive results and influence cross-organizational stakeholders and decision makers with different operational and jurisdictional responsibilities.\n\u2022 Significant company representation (preferably public)\n\u2022 Proven communication, relationship-building and collaboration skills\n\u2022 Responsibility for building, improving and/or re-engineering projects and programs\n\u2022 Development and updating of intra- and internet content\n\u2022 Familiarity with in-house learning management systems\n\u2022 Crisis management and handling\n\u2022 Proven commitment to delivering high-quality and timely output\n\u2022 Proven to have a strong work ethic demonstrated by being self-starter, resourceful and able to participate in a highly collaborative team-oriented environment\n\nAdditional Competencies/Skills:\n\u2022 Effective leadership skills\n\u2022 Effective organizational and creative problem solving skills\n\u2022 Strong understanding of the role of compliance professionals\n\u2022 Healthcare/pharmaceutical company experience\n\u2022 CIPP certification from the International Association of Privacy Professionals\n\u2022 Willingness to travel", "date_new": "2012-05-21 18:12:06", "url": "http://www.amgen.jobs/xml/28833040/job", "country": "United States", "company": "Amgen", "title": "Compliance Sr Mgr, Global Privacy and Data Protection, Policies, Training and Communication", "reqid": "15634BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833040}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15775BR\nJob Posting Title Executive Medical Director Global Development - Neurology\nCareer Category Clinical Development\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The neuroscience group is looking for a Global Development Leader to serve as co-lead on a multidisciplinary strategy team for a neuroscience product. This position will be located in Thousand Oaks, California.\n\nThe ideal candidate will represent the unified global medical voice and be the single point of accountability for evidence generation and scientific communication. The candidate will also be responsible for developing and executing the global scientific/medical evidence plan, collaborating cross-functionally and globally to integrate broad medical, scientific, and commercial input into the program and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, and Commercial outputs.\n\nKey Activities include the following:\n\nScientific\n- Oversee activities related to planning for studies across the product lifecycle\n- Interpret and integrate the results of research programs (e.g. study data, competitor data, publications) into the overall program strategy\n- Provide input to regulatory and safety groups for queries from regulatory agencies and negotiate with these groups\n- Provide medical and scientific input into key deliverables (e.g., regulatory filings and interactions, clinical study reports, publications and reimbursement submissions)\n- Provide strategic medical input into all aspects of the Commercialization process (pre-clinical through launch)\n- Approve medical/scientific components of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial materials and outputs\n- Communicate current safety and efficacy/effectiveness status of the product internally and externally\n- Review, approve, and execute publication plan\n- Provide medical support for licensing activities and support partner relationships\n\nLeadership, Collaboration and Management\n- Co-lead multidisciplinary product strategy team with the Global Commercial Leader\n- Co-author Global Strategic Plan\n- Lead Global Development Team and represent the team in Multidisciplinary and Senior Management Interactions\n- Mentor, coach, and oversee the performance of direct reports\n- Provide oversight and ensure alignment between clinical development and development operations.\n- Provide medical/scientific support to other functions as appropriate\n- Support regional needs for medical/scientific evidence generation\n- Develop key relationships with global opinion leaders\n\nKnowledge\n\n- Proven success in development and execution of clinical trials\n- Excellent knowledge of disease states in therapeutic area\n- Familiar with investigators or institutions in therapeutic area\n- Knowledge of regulatory affairs and drug safety\n- Proven track record in publications\n- Proven track record in commercialization and business practices\n- Documented success leading, managing and motivating staff in a complex, multi-functional matrix environment\nBasic Qualifications MD\n\u2022 Five (5) or more years of either industry or academic research experience\n\u2022 Previous management experience\nPreferred Qualifications Preferred Qualifications\n\u2022 MD plus accredited residency in relevant sub-specialty (ie, Neurology), board certified\n\u2022 Eight (8) or more years of either industry or academic research experience\n\u2022 Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n\u2022 Clinical research experience with Migraine programs", "date_new": "2012-05-21 18:11:47", "url": "http://www.amgen.jobs/xml/28833024/job", "country": "United States", "company": "Amgen", "title": "Executive Medical Director Global Development - Neurology", "reqid": "15775BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833024}, {"country_short": "USA", "city": "San Francisco - Field Based", "description": "Auto req 15782BR\nJob Posting Title Sr Biopharmaceutical Rep, Bone Health - Berkley, CA\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - California\nLocation (City) San Francisco - Field Based\nAmgen Job Description Territory #58317 Berkley, CA - covering - east bay area-Walnut Creek, Berkeley, Lafayette, Oakland\n\nAmgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. As a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications 2 years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries Previous experience selling in the osteoporosis market. Expert local knowledge in the primary care or specialty market. Successful launch experience in a highly competitive market. Outstanding business acumen including experience with: Medicare Part B Contracting Managed Care or pull-through Capital equipment or durable medical device sales Proven strategic account management Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve", "date_new": "2012-05-21 18:11:43", "url": "http://www.amgen.jobs/xml/28833020/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Bone Health - Berkley, CA", "reqid": "15782BR", "state": "California", "state_short": "CA", "location": "San Francisco - Field Based, CA", "uid": 28833020}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15638BR\nJob Posting Title Compliance Sr Mgr, Global Privacy and Data Protection Incident, Inquiry, Monitoring and Reporting\nCareer Category Compliance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Experienced Privacy Professional to work in the Worldwide Compliance and Business Ethics Department of a global pharmaceutical/biotechnology company (Company\u201d) located in Southern California. The individual will: (1) report directly to the Chief Privacy Officer, (2) develop and lead, in collaboration with the Chief Privacy Officer, programmatic efforts designed to build an effective global privacy and data protection incident, inquiry, monitoring and reporting function, (3) collaborate and work directly with in-house and external attorneys responsible for global privacy and data protection, (4) interact with global senior Company management as well as governmental agencies; (7) lead and direct the data protection efforts undertaken by the internal team dedicated to identifying, containing and remediating any found privacy and/or data protection vulnerabilities; (8) implement and execute effective testing, auditing, monitoring, tracking and reporting procedures and programs to ensure the success of the program, as measured by regular assessments and metric-based analysis; (9) compile clear, accurate and timely reports for senior management and the Board of Directors, as needed; (10) to support the Chief Privacy Officer in preparing Operating and/or Management Reviews, as required; and (11) support the global privacy and data protection needs of Company\u2019s Global Research and Development function.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Candidate should have legal training and 2+ years of relevant international privacy/data protection experience at a law firm or global company, including experience managing personal data incident inquiry and response efforts, implementing effective testing, monitoring, tracking and reporting procedures and programs, and compiling clear, accurate and timely reports for senior management including a Board of Directors\n\u2022 Health care/pharmaceutical company and multiple data stream (e.g., employee, vendor, customer, patient) experience, is a plus\n\u2022 Candidate should also possess a working knowledge of information technology/security capabilities\n\u2022 Experience should include meaningful project direction and coordination responsibility; significant experience working with senior management, including both internal and external law departments\n\u2022 Significant company representation (preferably public); and responsibility for global, cross-functional data protection initiatives\n\u2022 Candidate must be able to handle, prioritize and follow through on diverse issues on a timely basis. Candidate must be a self-starter and hard worker, resourceful and able to participate in a highly collaborative team-oriented environment.\n\u2022 Proven ability to effectively and timely manage multiple initiatives and cross-departmental projects (i.e., strong project management skills).\n\u2022 Proven ability to multi-task, thrive and deliver in a highly-regulated and increasingly-demanding matrixed corporate environment.\n\u2022 Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on an evolving corporate and regulatory landscape.\n\u2022 Ability to deal well with ambiguity and complex situations.\n\u2022 Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude.\u2022 Demonstrable political acumen to collaborate, drive results and influence cross-organizational stakeholders and decision makers with different operational and jurisdictional responsibilities.\n\u2022 Proven communication, relationship-building and collaboration skills.\n\u2022 Experience in building programs, process improvements and/or re-engineering.\n\u2022 Experienced in crisis management and handling.\n\u2022 Proven commitment to delivering quality and timely output.\n\u2022 Legal training\n\u2022 2+ years of relevant privacy experience at a law firm or global company\n\u2022 Strong awareness of global privacy laws and regulations and experience with associated compliance\n\u2022 Substantial experience building and/or implementing operational privacy and data protection programs in a corporate environment (global experience preferred)\n\u2022 Strong strategic thinking skills and ability to translate strategy into action plans\n\u2022 Excellent ability to interact and build relationships at all levels of management and staffing across organizational/jurisdictional boundaries\n\u2022 Ability to understand, plan and navigate in a matrixed environment\n\u2022 Excellent project management skills\n\u2022 Excellent command of English (spoken and written) and public-speaking skills\n\u2022 Availability in crisis\n\u2022 Strong working knowledge of information technology systems would be an advantage\n\u2022 Understanding of global aspect of position\n\u2022 Effective leadership skills\n\u2022 Effective organizational and creative problem solving skills\n\u2022 Self-starter with a high level of initiative and strong work ethic\n\u2022 Strong understanding of the role of compliance professionals\n\u2022 Healthcare/pharmaceutical company experience", "date_new": "2012-05-21 18:11:30", "url": "http://www.amgen.jobs/xml/28833012/job", "country": "United States", "company": "Amgen", "title": "Compliance Sr Mgr, Global Privacy and Data Protection Incident, Inquiry, Monitoring and Reporting", "reqid": "15638BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833012}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 15718BR\nJob Posting Title Clinical Operations Manager\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nField Based\nAmgen Job Description Initiates and coordinates feasibility assessment, potential investigator identification\nand site selection\nStrategically plans and coordinates Amgen sponsored trials (forecasting,\nresourcing, timelines, baseline recruitment)\nAdapt ICF to local requirements\nDefines study specific processes including study communication plans\nEnsures all study staff understand study deliverables and timelines\nTracks local trial implementation, data collection and study reporting\nReviews and approves monitoring reports and Site Initiation Packages (SIPs)\nResponsible with Medical staff for vendor selection and performance evaluation for\nlocal studies, including HE studies (services other than FSP)\nProvides regular updates on study progress to DOM and study sponsors as\nrequired, identifying barriers to site activation and patient enrollment and identifying\npotential solutions\nEnsures quality of study execution\nEscalates study-related issues\nProvides Amgen presence at investigator meetings / key visits\nCoordinate & actively participate at local investigators meetings\nReview GCA Site audit reports and work in conjunction with FSP staff and Site staff\nas required to fix issues\nKey interface with Safety reporting group to oversee collection and distribution of safety reports from sites via FSP, including query follow up\nProject manages local clinical study teams\nCoordinates SACOM tasks, according to the COM-SACOM RASCI, when those are\nallocated to support COMs in the oversight of operational activities related to\nplanning, executing and reporting of phase 3 / 4 studies\nSingle point of contact at a project level for LOC staff and GSM\nPartners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs)\nIdentifies and highlights risk areas (concerning operational readiness,\ncommunication and management)\nEnsures CRA receives necessary TA-related and study-related training\nCoordinates local study-related administrative tasks e.g. information to finance,\nstatus update to BU, status updates in local meetings\nActively participates in the regional COM network as required\nParticipate in the hub or country level Functional Management Team (FMT Governance)\nBasic Qualifications BA/BS/BSC or qualified nurse (RN)\nwork experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained\nworking on clinical trials in a biotech, pharmaceutical or CRO company or other relevant clinical setting)\nPreferred Qualifications Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company\nClinical trial management experience\nOperational performance measurement experience\nInternational collaboration experience", "date_new": "2012-05-21 18:11:05", "url": "http://www.amgen.jobs/xml/28832994/job", "country": "Netherlands", "company": "Amgen", "title": "Clinical Operations Manager", "reqid": "15718BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 28832994}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15617BR\nJob Posting Title Feasibility & Patient Recruitment Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Manager, Feasibility & Patient recruitment will establish strategies and decision making processes to address the barriers in reaching goals around feasibility and identifying and recruiting appropriate patient populations within established timelines. There are many responsibilities associated with this role key to ensuring the timely and effective delivery of Amgen\u2019s strategy to its stakeholders including: setting project timelines and priorities based on study objectives and ongoing assignments; organizing and leading cross-functional meetings to develop and execute the enrollment forecasting strategies for our programs; identifying patient profiles, patient market dynamics, potential recruitment barriers, regional recruitment boundaries, triggers, contingency plans and implementation plans by country and site. Additionally, this individual will serve as a consultant and advisor to study teams and regions to help them maximize their enrollment rates. He/She will also gather historic regional performance data, track and report successes of various recruitment strategies and manage the inventory of recruitment tools and recruitment vendors and communicate best practices to teams and site management staff ensuring accurate and timely information exchange between departments. Also critical to the success of this role, will be maintaining therapeutic knowledge of Amgen products; knowledge of performance measurement at a departmental level and a fundamental understanding of the organizational change management process.\nBasic Qualifications ?Doctorate degree\nOR\n?Master\u2019s degree & 3 years of directly related experience\nOR\n?Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Preferred Qualifications - Advanced Degree preferred\n- Excellent communication, organizational, and interpersonal skills\n- Ability to plan and work on projects with minimal supervision\n- Effective at working with colleagues from all departments and organizational levels while meeting commitments.\n- Experience working as a member of global drug development teams preferred\n- Previous management experience of direct reports or clinical projects\nProven experience in a pharmaceutical environment\n- Good experience of biopharmaceutical clinical research\n- Experience involving a broad exposure to biopharmaceutical clinical development process and procedures\n- Experience developing and implementing recruitment and retention plans\n- Experience working independently across departments within a team/matrix environment\n-Detailed knowledge of international clinical research and drug development\n- Strong understanding of program and study operations in an international setting\n-Relevant therapeutic area(s)\n- Strong computer literacy, including word processing, presentation, spreadsheet and project management applications\n- Organizational change management process", "date_new": "2012-05-21 18:10:58", "url": "http://www.amgen.jobs/xml/28832988/job", "country": "United States", "company": "Amgen", "title": "Feasibility & Patient Recruitment Mgr", "reqid": "15617BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28832988}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 11978BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Fort Worth S, TX\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Texas\nLocation (City) Field Based\nAmgen Job Description Territory #33707, Fort Worth S - covers, Fort Worth, Arlington, Midland\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-05-21 18:10:40", "url": "http://www.amgen.jobs/xml/28832969/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Fort Worth S, TX", "reqid": "11978BR", "state": "Texas", "state_short": "TX", "location": "Field Based, TX", "uid": 28832969}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15771BR\nJob Posting Title Biostatistical Programming Mgr\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Biostatistical Programming Manager will be accountable for Global Statistical Programming (GSP) study activities and oversight of contingency workers within the product team. This role is part of a Therapeutic study team located at Amgen's headquarters in Thousand Oaks, CA .\n\nThe Biostatistical Programming Manager is responsible for:\n\u2022 Writing, testing and validating software programs in UNIX to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications\n\u2022 Writing and/or reviewing statistical programming plans and dataset specifications.\n\u2022 Ensuring the analysis and presentation of biomedical data is accurate and complete.\n\u2022 Adherence to Amgen Policies, SOPs and other controlled documents\nBasic Qualifications \u2022 Bachelor\u2019s degree & 5 years of directly related experience\nPreferred Qualifications \u2022 MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject\n\u2022 Biostatistical Programming using the SAS System\n\u2022 Drug Development (pre-, early, late and/or observational) in related industries or academic research\n\u2022 Project planning\n\u2022 Process improvement participation\n\u2022 International co-operation\n\u2022 Team participation and effectiveness\n\u2022 Six (6) years relevant career experience", "date_new": "2012-05-20 19:44:41", "url": "http://www.amgen.jobs/xml/28824683/job", "country": "United States", "company": "Amgen", "title": "Biostatistical Programming Mgr", "reqid": "15771BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28824683}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15090BR\nJob Posting Title Principal IS Architect - Principal Design Engineer\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\n\nThe Principal Design Engineer for Amgen's Enterprise IS Technology Services (EISTS) Design & Engineering is part of a team responsible for the development, delivery, and life cycle of all Amgen IS Infrastructure technologies. Multiple cross-disciplinary experts are being sought to provide Engineering direction across the Infrastructure organization in their areas and relationships to other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle.\n\nJob Responsibilities\n\n\u2022 Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas.\n\n\u2022 Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners.\n\n\u2022 Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS.\n\n\u2022 Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans.\n\n\u2022 Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency.\n\n\u2022 Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks.\n\n\u2022 Lead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Master\u2019s degree\n\u2022 Bachelor\u2019s Degree in Information Systems, Computer Science, or Electronics\n\u2022 10 + years experience working within Information Systems\n\u2022 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus.\n\u2022 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with key Internet technologies and protocols\n\u2022 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus\n\u2022 5+ years biotechnology or pharmaceutical experience are a plus.\n\u2022 Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments.\n\u2022 The ability to function in multiple roles based on project demands.\n\u2022 Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines.\n\u2022 Excellent oral, written and interpersonal communication skills.\n\u2022 Experience with a range of IT service, architecture, engineering, and design frameworks and languages\n\n\u2022 This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices.\n\u2022 Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes.\n\u2022 This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services", "date_new": "2012-05-20 19:42:38", "url": "http://www.amgen.jobs/xml/28824682/job", "country": "United States", "company": "Amgen", "title": "Principal IS Architect - Principal Design Engineer", "reqid": "15090BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28824682}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15091BR\nJob Posting Title Principal IS Architect - Principal Design Engineer\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\n\nThe Principal Design Engineer for Amgen's Enterprise IS Technology Services (EISTS) Design & Engineering is part of a team responsible for the development, delivery, and life cycle of all Amgen IS Infrastructure technologies. Multiple cross-disciplinary experts are being sought to provide Engineering direction across the Infrastructure organization in their areas and relationships to other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle.\n\nJob Responsibilities\n\n\u2022 Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas.\n\n\u2022 Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners.\n\n\u2022 Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS.\n\n\u2022 Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans.\n\n\u2022 Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency.\n\n\u2022 Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks.\n\n\u2022 Lead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Master\u2019s degree\n\u2022 Bachelor\u2019s Degree in Information Systems, Computer Science, or Electronics\n\u2022 10 + years experience working within Information Systems\n\u2022 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus.\n\u2022 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with key Internet technologies and protocols\n\u2022 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus\n\u2022 5+ years biotechnology or pharmaceutical experience are a plus.\n\u2022 Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments.\n\u2022 The ability to function in multiple roles based on project demands.\n\u2022 Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines.\n\u2022 Excellent oral, written and interpersonal communication skills.\n\u2022 Experience with a range of IT service, architecture, engineering, and design frameworks and languages\n\n\u2022 This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices.\n\u2022 Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes.\n\u2022 This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services", "date_new": "2012-05-20 19:42:07", "url": "http://www.amgen.jobs/xml/28824681/job", "country": "United States", "company": "Amgen", "title": "Principal IS Architect - Principal Design Engineer", "reqid": "15091BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28824681}, {"country_short": "TUR", "city": "Field Based", "description": "Auto req 15762BR\nJob Posting Title Sr Biopharmaceutical Rep\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Turkey\nLocation (City) Field Based\nAmgen Job Description Provides input and agrees to territory annual sales objectives with manager\nCollaborates with manager to develop and implement territory POA and key account plans\nCollaborates with relevant stakeholders (Medical Affairs, etc.) to agree on account plan objectives/responsibilities\nEvaluates progress vs. plan monthly, and agrees to course corrections with manager where necessary\nDevelops and maintains up-to-date customer/market understanding\nReports customer activity in the CRM system and ensures customer profiles are kept up-to-date\nDetails products in accordance with Amgen\u2019s sales process and agreed marketing strategy\nProvides feedback to product/sales management on competitor activity\nOperates within the agreed expense budget\nContinuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs\nEnsures open communication and shares best practices\nParticipates in the Amgen Performance Management System (MAP)\nBasic Qualifications Minimum 3 to 5 years of experience in the pharmaceutical industry in a sales-related job\nSome experience with computer systems (CRM databases and MS Office)\nPreferred Qualifications Bachelor\u2019s degree in life science or (bio) medical sciences\nKnowledge of Customer Relation Management principles\nExposure to interactions with various disciplines and organizational levels\nExposure to project management principles\nFluency in English, both in oral and written communication", "date_new": "2012-05-18 18:07:55", "url": "http://www.amgen.jobs/xml/28792893/job", "country": "Turkey", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "15762BR", "state": null, "state_short": null, "location": "Field Based, TUR", "uid": 28792893}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15636BR\nJob Posting Title Sr Assoc Clinical Trial Mgmt Systems\nCareer Category Clinical\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Review and track global organizational performance metrics\nHighlight performance gaps and identify root cause; recommend meaningful improvement opportunities\nCo-ordinate the creation and distribution of metrics reports and other status reports as required\nManage benchmarking efforts\nInitiate and build relationships with study teams and business partners to understand study requirements\nDevelop protocol builds and budgets to meet study team requirements\nPartner with appropriate Dev IS resources on CAAS tools to meet client needs\nCollaborate with appropriate Dev IS resources of other systems to ensure consistency of data standards and quality\nCreate and distribute written materials to support training, data integrity, or other special projects (as assigned)\nProvide clients with outstanding support through effective communications and robust processes\nLead special projects as assigned\nGather stakeholder requirements on applications, metrics and reports\nDevelop processes and reporting to ensure compliance to data standards and compliance to business processes\nBasic Qualifications Master\u2019s degree\nOR\nBachelor\u2019s degree & 2 years of directly related experience\nOR\nAssociate\u2019s degree & 6 years of directly related experience\nOR\nHigh school diploma / GED & 8 years of directly related experience\nPreferred Qualifications BA/BS/BSc in the sciences or RN\nSpecialist work experience in business support role in the life sciences or medically related field\n5 years work experience in life sciences or medically related field, including 2 years of clinical development experience involving clinical applications (e.g. CTMS, IVRS, EDC", "date_new": "2012-05-18 18:07:27", "url": "http://www.amgen.jobs/xml/28792892/job", "country": "United States", "company": "Amgen", "title": "Sr Assoc Clinical Trial Mgmt Systems", "reqid": "15636BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28792892}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 15751BR\nJob Posting Title Corporate Account Mgr - Southwest PPM CAM\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Arizona\nUnited States - Colorado\nUnited States - Missouri\nUnited States - Nebraska\nUnited States - New Mexico\nUnited States - Oklahoma\nUnited States - South Dakota\nUnited States - Texas\nUnited States - Utah\nUnited States - Wyoming\nLocation (City) Boulder\nField Based\nLake Centre\nLongmont\nAmgen Job Description Territory #17001 - Southwest PPM CAM\nArea covered: TX, AZ, NM, UT, CO, OK, WY, Arkansas, W. S Dakota, W. Nebraska, S. Missouri, N. Louisiana\n\nThe PPM (Physician Practice Management) Corporate Account Manager's primary responsibility is to Assess and diagnose the current business environment in each key account in relation to Amgen Oncology products and plan actions required for success in these accounts.\n\u2022 Develop and implement in partnership with BSR/DM, a comprehensive business plan to gain trial and adoption of Aranesp, XGEVA, and Neulasta. Plan will include but not limited to comprehensive account profile, business strategies, financial models, key result areas, information systems, inventory management strategies, competitive intelligence for each account, current resources being utilized, new resources to be implemented, action plan for key personnel, timelines for execution of above, follow-up action steps to ensure compliance, and coordination / procurement of all available resources. (Primary customers include executive management (CEO, CFO, Director of Pharmacy Services, or fiscal intermediaries), medical directors, and key physicians and secondary customers include pharmacists and nurses).\n\u2022 Facilitates account management by coordinating selling activities and customer interactions through effective leadership, communication and implementation with field sales staff to ensure appropriate customer needs are met.\n\u2022 Implements approved plans and monitors plan execution against targets.\n\u2022 Develops and implements business reviews of key accounts on at least a quarterly basis with RSDs and GPO NAMs\n\u2022 Serve as a resource at RSD discretion for DM's/BSR's when appropriate for accounts within their districts / territories. Will include joint customer calls, consultation on clinic accounts outside of assigned key accounts, and specific skill building with BSR's on clinic selling.\n\u2022 Participates in other projects as assigned by management.\n\nEnvironment: Driving/Extensive Travel including overnights (up to 75% of time).\n\u2022 Excellent interpersonal skills, which include networking, influencing, negotiation, presentation and written and verbal communication.\n\u2022 Demonstrated Business Acumen and Excel skills.\n\u2022 Demonstrated leadership ability with a focus on influence, impact and leading without authority.\n\u2022 Requires excellent customer service skills.\n\u2022 Ability to work independently.\n\u2022 Ability to understand and identify key staff and departments that influence decision-making for biopharmaceutical product utilization within each key account, then maintain and grow relationships with these key decision makers within the accounts\n\u2022 Ability to identify and obtain appropriate Amgen resources to achieve account objectives.\n\u2022 Contract negotiation.\n\u2022 Ability to analyze and interpret clinic economics/financial performance.\n\u2022 Ability to successfully navigate through clinic reimbursement.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022\u2022 BA/BS degree\n\u2022 7+ years of healthcare sales and/or marketing experience\n\u2022 Clinic, hospital, oncology, injectable experience preferred\n\u2022 Reimbursement/managed care experience preferred\n\u2022 Advanced Degree preferred\n\u2022 Strong business acumen and analysis skills\n\u2022 Proficient with Excel and PowerPoint\n\u2022 Demonstrated track record of success\n\nDiscretion: Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Impact: Failure to obtain results or erroneous decisions or recommendations would usually result in financial impact. Liaison: Frequent inter-organizational and outside customer contacts. \u2018Do It\u2019 level of competency development as defined by the ACT competency model in: Professional Mastery, Managing the Business, Communication, and Leadership with focus on: Excellent communication skills, organizational skills and presentation skills to senior level management. Understand financial impact of Amgen products. Translates brand planning/POA into account specific business plans. Ability to work in teams, to coordinate development of Amgen account teams to cross-functionally match players between organizations. Ability to maintain and grow customer relationships. Negotiation skills. Proven analytical skills / business acumen especially in the area of resource allocation. Ability to analyze and interpret complex clinical problems", "date_new": "2012-05-18 18:07:26", "url": "http://www.amgen.jobs/xml/28792891/job", "country": "United States", "company": "Amgen", "title": "Corporate Account Mgr - Southwest PPM CAM", "reqid": "15751BR", "state": "Arizona", "state_short": "AZ", "location": "Boulder, AZ", "uid": 28792891}, {"country_short": "GBR", "city": "Cambridge", "description": "Auto req 15726BR\nJob Posting Title Regulatory Affairs Director - Biosimilars Policy\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Cambridge\nUxbridge\nAmgen Job Description Overview:\n\nThe Global Regulatory Affairs and Safety (GRAAS) Biosimilar Policy Director is accountable for defining Amgen positions on the scientific, medical and regulatory aspects of biosimilars. Advocating those standards to external policy makers while concurrently providing key internal subject-matter expertise to cross-functional executive leadership and teams\n\nResponsibilities:\n\n\u2022 Develop, direct and deliver strategic regulatory plans that are in-line with regulatory and business needs\n\u2022 Develop innovative solutions to complex problems through in-depth analysis, coordination and negotiation with subject-matter experts and key decision makers\n\u2022 Work in partnership with cross-functional teams and Amgen leadership to develop regulatory plans that support the direction of the business\n\u2022 Advocate to a broad spectrum of internal and external stakeholders the adoption of policies for achieving regulatory and business goals\n\u2022 Develop mutually beneficial strategic alliances with internal and external subject-matter experts and external key decision makers\n\u2022 Engage in direct advocacy with national, regional and global policy makers and regulators\n\u2022 Represent Amgen and the innovator industry in policy testimony and on trade association key issue team\n\u2022 May have direct reports, but spends more than 50% of their time working as a individual contributor\n\nKey Relationships:\n\n\u2022 Internal cross-functional project teams (national, regional and global)\n\u2022 Amgen leadership teams\n\u2022 Internal subject-matter experts and external key decision makers\n\u2022 Government and Regulatory Agency officials\nBasic Qualifications \u2022 University degree with significant directly related experience\nPreferred Qualifications \u2022 Science-background (eg. BSc, PhD, MD)\n\u2022 Experience in regulatory or clinical development, ideally with biologics\n\u2022 Understanding of national and global healthcare system, including payers\n\u2022 Critical thinker, able to analyze and critique data\n\u2022 Intellectually creative, able to assess a situation from multiple perspectives\n\u2022 Skilled and credible advocate with experience in 1:1 engagement, large audiences, panel debates\n\u2022 Able to form and defend a position under challenge", "date_new": "2012-05-18 18:07:00", "url": "http://www.amgen.jobs/xml/28792889/job", "country": "United Kingdom", "company": "Amgen", "title": "Regulatory Affairs Director - Biosimilars Policy", "reqid": "15726BR", "state": null, "state_short": null, "location": "Cambridge, GBR", "uid": 28792889}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15609BR\nJob Posting Title GRAAS Operations Senior Manager\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The focus of this group is to support the business and project needs of the GRAAS International Region through detailed strategic planning and delivery of analytical, logistical, financial, and organisational data, support and advice.\n\nSpecifically, this job provides comprehensive strategic business & operations support within GRAAS International across a broad range of strategic issues (governance, organisation, productivity, etc.) and assist the GRAAS International Core Senior Management Team (SMT) in effective and productive leadership and management of the GRAAS International business and organisation and internal and external communication.\n\nKey activities include:\n- Provide strategic and operational support including strategic planning and communications, operational project management and implementation of functional projects\n- Contribute through SME or facilitation to department and/or cross-functional projects and process improvement initiatives\n- Support for the (sub-functional) leadership through tracking of project progress, issue tracking, problem solving, organizational management, and presentation development\n- Implement tools, techniques and processes to enable continuous improvement across GRAAS International regions\n- Provide cross-functional and GRAAS internal communications where applicable\n- Support and/or direct leadership of various external development initiatives partnering with global functions and regional leaders\n- Provide strategic analysis managing benchmarking to capture industry best practices, organization design and operations for critical business functions\n- Develop and manage budgets and contribute to the International budget process (if requested)\n- Manage special projects, as required.\n- Ensure cross-functional liaison (e.g. ICO, GDO, Operations)\n- Contribute through influence and direct support to the activities and goals of other international functions\n- Support to GRAAS International VP and /or GRAAS International Core Senior Management Team (SMT)members with International governance forums (e.g. IMC, ISC, EMST and RMCs)\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - Solid understanding of working within global complex matrix organisations\n- Ability to engage different personalities\n- Ability to influence\n- Motivating and leading (cross functional) teams on a functional level\n- Strong critical thinking\n- Planning and Prioritisation\n- Good interpersonal skills\n- Knowledge of the fields of Regulatory & Safety and biopharmaceutical industry\n- Excellent communication skills\n- Experience of working with and for senior executives\n- Stakeholder management\n- Presentation skills\n- Microsoft Office applications\n- Basic Financial Understanding\n- Project management tools and methodologies\n- Change Management", "date_new": "2012-05-18 18:06:17", "url": "http://www.amgen.jobs/xml/28792882/job", "country": "United States", "company": "Amgen", "title": "GRAAS Operations Senior Manager", "reqid": "15609BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28792882}, {"country_short": "USA", "city": "San Francisco - Field Based", "description": "Auto req 15745BR\nJob Posting Title Sr Biopharmaceutical Rep, Bone Health - San Francisco, CA\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - California\nLocation (City) San Francisco - Field Based\nAmgen Job Description Territory #58311 San Francisco, CA\n\nAmgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. As a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications 2 years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries Previous experience selling in the osteoporosis market. Expert local knowledge in the primary care or specialty market. Successful launch experience in a highly competitive market. Outstanding business acumen including experience with: Medicare Part B Contracting Managed Care or pull-through Capital equipment or durable medical device sales Proven strategic account management Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve", "date_new": "2012-05-17 20:58:43", "url": "http://www.amgen.jobs/xml/28771086/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Bone Health - San Francisco, CA", "reqid": "15745BR", "state": "California", "state_short": "CA", "location": "San Francisco - Field Based, CA", "uid": 28771086}, {"country_short": "USA", "city": null, "description": "Auto req 15691BR\nJob Posting Title Compliance Senior Manager - GCP - Field Based\nCareer Category Compliance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Field Based\nLocation (City) Field Based\nAmgen Job Description This is a field based position which can be based anywhere near a major US metropolitan area with the preference being the Eastern US.\n\nThis is an exciting opportunity for a Compliance Senior Manager position with Amgen's Global Compliance Auditing (GCA) team. It is a key GCA position for planning and participating in global audits of Amgen\u2019s clinical trials and pharmacovigilance activities. The position also provides a wide range of compliance advice and may also support regulatory inspections of clinical sites and Amgen facilities. This position is home-based in the US and reports into a Senior Compliance Manager, who manages four other home based staff. The home-based (regional) auditors are part of Amgen\u2019s Global Compliance Auditing department located in Thousand Oaks, Ca.\n\nThe position requires approximately 40% travel to US and international audit sites.\n\nKey responsibilities of the Compliance Senior Manager include:\n- Plan, conduct and report routine and directed clinical trial and PV compliance audits\n- Provide GCP and PV compliance advice in line with current best practices\n- Manage the planning and implementation of compliance programs for specific area of expertise and act as point of contact for this area\n- Host and/or play a lead role in regulatory authority inspections\n- Lead GCA process improvement initiatives\n- Author and contribute to the development of GCA cross-functional controlled documents\n- Provide coaching / mentoring to staff and provide cross training for staff in area of expertise\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - Bachelor\u2019s degree in Science\n- Minimum of 5 years experience in GCP/Pharmacovigilance/auditing\n- Experience supporting regulatory authority inspections of clinical research and/or pharmacovigilance activities\n- International auditing experience\n- Participation in process improvement initiatives\n- Leadership or mentoring experience\n- 7 or more years experience in GCP/Pharmacovigilance/auditing\n\n\nKNOWLEDGE\n- Knowledge of regulations applicable to area of technical expertise\n- General knowledge of clinical development and PV process and operations\n- Knowledge of audit/compliance program design and audit methodology\n\nKEY COMPETENCIES\n- Team work\n- Motivation skills\n- Leadership skills\n- Verbal and written communication\n- Results oriented\n- Analytical skills\n- Time management", "date_new": "2012-05-17 20:58:35", "url": "http://www.amgen.jobs/xml/28771082/job", "country": "United States", "company": "Amgen", "title": "Compliance Senior Manager - GCP - Field Based", "reqid": "15691BR", "state": null, "state_short": null, "location": "Virtual, USA", "uid": 28771082}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 15464BR\nJob Posting Title Sr Associate QA\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Job Description\n\nPosition Title: QA Snr Associate\nReports to:  QP\nGroup/Division: Amgen Dun Laoghaire\nDepartment:  QA\nShift        Yes 24/5\n\nPosition Summary:\n\nThis job specification outlines the general responsibilities associated with the role of QA Snr Associate at ADL. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.\n\nThe QA Snr Associates duties are as follows;\n\n\u2022 Compiles QC and Manufacturing batch records and reviews for compliance to cGMPs and\nProduct Licenses.\n\n\u2022 Review and approve Master Batch Records\n\n\u2022 Review non conformances for completeness\n\n\u2022 Prepare the agenda for Site Quality Review Team and submits non conformances for\nreview/discussion.\n\n\u2022 Prepares the SQRT minutes.\n\n\u2022 Assigns expiry date to products.\n\n\u2022 Prepare deviation trend reports bi annually to establish any evident trends.\n\n\u2022 Schedules products to be placed on the stability program\n\n\u2022 Status changes and yields product on the computer system\n\n\u2022 Prepares non conformance reports for shipments as required\n\n\u2022 Tracks CAPA\u2019s detailed in non conformance reports\n\n\u2022 Writes, reviews and approves Standard Operating Procedures in accordance with Amgen\nPolicies\n\n\u2022 Prepares Monthly Metrics.\n\n\u2022 Ensure compliance with Amgen procedures\n\n\u2022 Performs Quality Audits to ensure compliance with cGMPs\n\n\u2022 Maintains databases and other informational systems as necessary.\n\n\u2022 Prepares the KPI reports as required.\n\n\u2022 Complies with responsibilities as outlined in the site Safety Statement section 3.6.\n\n\u2022 Performs all tasks with due care and attention and in accordance with Good\nManufacturing Practices and Amgen requirements, policies and procedures.\n\n\u2022 Participates in a learning and development programme which will include goal setting, annual performance reviews and   individual development plans.\n\n\u2022 Is a champion for safe working practices and safety initiatives within their functional\narea.\nBasic Qualifications Education:\n\nThird level qualification, preferably to degree level, in a Science discipline.\n\nExperience:\n\nMinimum three years industrial experience or equivalent\nPreferred Qualifications Knowledge and training in QMTS, SAP, EBR and Maximo  Strong organizational skills and ability to manage multiple tasks at one time Ability to follow assignments through to completion and meet timelines Self motivated Strong communication skills (both written and verbal) Demonstrated ability to work as both a team player and independently Ability to evaluate documentation and operations according to company procedures Ability to make decisions independently or elevate to management, as appropriate in an environment that balances business need, quality and compliance risk Strong word processing, database and spreadsheet application skills", "date_new": "2012-05-17 20:58:26", "url": "http://www.amgen.jobs/xml/28771078/job", "country": "Ireland", "company": "Amgen", "title": "Sr Associate QA", "reqid": "15464BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 28771078}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15746BR\nJob Posting Title Specialist IS Bus Sys Analyst\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position will be part of the Information System Global Regulatory Affairs and Safety team within the Development Information system (Dev IS) function and will be responsible for management of the Global Regulatory Affairs and Safety (GRAAS) system solutions.\n\nThis position will serve as a liaison between Safety business function and Information system team and to provide technical solutions to the GRAAS business function.\n\nThe primary responsibilities of this position will be to support and drive the following:\n\u2022 Partner with Amgen Safety Globally to translate high-level business requirements into functional specifications for system implementation and configuration.\n\u2022 Communicate and manage the client area expectations in the delivery of solutions.\n\u2022 Develop requirements and design artifacts including architectural components\n\u2022 Develop system testing and validation strategy\n\u2022 Provide technical support to implement application software changes\n\u2022 Manage system maintenance downtime needs between the user community and system support personnel\n\u2022 Partner with IS shared service group to manage the safety platform\n\u2022 Participate in Incident and Problem Management functions for incidents related to safety platform\n\u2022 Liaise with vendors to obtain resolution to technical application issues\n\u2022 Responsible for planning and execution of annual Disaster Recovery exercise for safety platform.\n\u2022 Lead the system upgrade effort including planning, documenting and implementing.\n\u2022 Following Amgen change management process, manage indentified issues/incidents from production system(s), perform root cause analysis and provide appropriate resolution.\n\u2022 Organize and lead meetings of cross functional IS and supplier support groups. Will be expected to develop recommendations and lead the implementation of improvements in documented practices and reports.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications This position requires advanced knowledge and proven skills in administration and management of drug safety systems; a proven record of leading changes and delivering software solutions by working in a highly regulated and service oriented environment; and in depth knowledge and understanding of information system infrastructure.\n\nRequires a candidate with experience in all aspects of SDLC from requirements, design, testing, strong business analysis and data analysis.\n\n\u2022 Experience of working on major programs/projects that involved multiple stakeholders from inception to completion\n\u2022 Knowledge of SDLC and must have experience in a highly regulated environment closely with quality and validation\n\u2022 Strong analytical skills, good at system design and architect\n\u2022 Working knowledge of RDBMS, such as Oracle; advanced experience of writing SQL queries and developing functions/packages with PL/SQL\n\u2022 Knowledge of database and data warehouse modeling\n\u2022 Familiar with change control process; experience of maintaining and supporting systems\n\u2022 Experience with Oracle Argus Suite is preferred.\n\u2022 Good documentation and communication skills\n\u2022 Must be capable of prioritizing tasks and multi-tasking in an environment that can require changing and varied demands from ad hoc reporting to management to engaging development staff at a technical level to resolve issues and meet release schedules.\n\u2022 Demonstrate learning agility\n\u2022 Should be self motivated and a quick learner", "date_new": "2012-05-17 20:57:34", "url": "http://www.amgen.jobs/xml/28771039/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Bus Sys Analyst", "reqid": "15746BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28771039}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 15588BR\nJob Posting Title CDM Systems Mgr\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nThousand Oaks\nAmgen Job Description The CDM Systems Manager will serve as global manager and as a technical team point-of-contact within Electronic Trial Operations (ETO). This role will work with cross-functional Amgen teams of Clinical, Biostatistical, Data Management, Supply Chain, as well as with external representatives. This role will drive the design, implementation and maintenance of outsourced electronic solutions in support of clinical trials. The role will provide the technical oversight required to ensure adherence to study specific requirements, Amgen policies, procedures, standards all within a regulated environment.\n\nThe position is expected to partner effectively with other CDM System staff to ensure high quality deliverables and to aggressively pursue opportunities to further propagate the use of ETO technology and services.\n\nKey Responsibilities include:\n\u2022 Lead study level system requirements meetings with internal and external clients\n\u2022 Design and oversee the development of study specific technical documents\n\u2022 Document possible risk and implement mitigation plans\n\u2022 Manage project related timelines and associated activities\n\u2022 Identify and track study-related technical issues to resolution\n\u2022 Provide a supportive framework for continuous process and quality improvements\n\nOther responsibilities include:\n\u2022 Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines.\n\u2022 Provide feedback on clinical protocols as it relates to electronic solutions and ensure the use of data standards and adoption of configurable modules\n\u2022 Procurement and program management of resources, timeline, and services from both internal and external service providers\n\u2022 Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology\n\u2022 Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers\n\u2022 Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives\n\u2022 Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished\n\u2022 Develop strong relationship with external providers (such Vendor Providers) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications 5 years of experience implementing clinical systems, such as CTMS, EDC, IVRS, IWRS, ePRO or other related technology in the pharmaceutical/biotechnology industry\n\n3 years of biopharmaceutical clinical research experience\n\nCandidate will demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\n\u2022 6+ or more years of experience in a technical role within clinical data management, clinical development, clinical setting, or IS/IT\n\u2022 Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Experience successfully implementing and IVR and IWR systems\n\u2022 Work experience integrating other clinical technologies including but not limited to such technologies such as eClinical, RAVE, EDC or other related technology in the pharmaceutical/biotechnology industry\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Working knowledge of Good Clinical Practices and Global Regulatory regulations as applicable\n\u2022 Previous line management experience", "date_new": "2012-05-17 20:57:32", "url": "http://www.amgen.jobs/xml/28771038/job", "country": "United States", "company": "Amgen", "title": "CDM Systems Mgr", "reqid": "15588BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 28771038}, {"country_short": "BEL", "city": "Field Based", "description": "Auto req 15630BR\nJob Posting Title Product Specialist Oncology\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Belgium\nLocation (City) Field Based\nAmgen Job Description Develops and implements territory Plan of action (POA) and key account plans.\nAchieve/exceeds POA.\nEvaluates progress vs. plan monthly, and conducts systematic analysis of problems.\nAnticipates situation in which performance goals may be missed in order to make appropriate adjustments\nProactively collaborates with Cluster/Territory Team members to ensure alignment throughout the Territory and agrees on actions regarding specific accounts and key customers\nContribute s through constructive feedback\nApplies knowledge of retail/hospital environment to pre-calls plans by selecting the right message which suits the needs of different stakeholders\nResponds to competitive threats and opportunities by keeping informed and contributing to competitive intelligence\nMeets customer expectations in terms of standards of service and addresses services breakdowns in a timely fashion\nReports customer activity in the Customer Relation Management (CRM) system and ensures customer profiles are kept up to date\nConsistently uses Amgen\u2019s Performance 4 selling platform\nOperates within the agreed expense budget aligned with POA priorities\nOrganizes and manages activities in a timely fashion and follow-up with customers\nAttends and positively contributes to all relevant training programs. Plays a leading role in cycle meeting s and training events.\nDemonstrates mastery of objection handling techniques\n\nRegion: Flemish Brabant, Antwerp South and 3 hospital groups in East Flanders\nBasic Qualifications Minimum 3 to 5 years of experience in the pharmaceutical industry in a sales-related job\nBasic knowledge of and experience in a hospital environment\nExperience with computer systems (CRM databases and MS Office)\nFluency in Dutch and English, both in oral and written communication\nPreferred Qualifications Bachelor\u2019s degree in life science or (bio) medical sciences\nKnowledge of Customer Relation Management (CRM) principles\nExposure to interactions with various disciplines and organizational levels\nExposure to project management principles", "date_new": "2012-05-16 19:09:00", "url": "http://www.amgen.jobs/xml/28737817/job", "country": "Belgium", "company": "Amgen", "title": "Product Specialist Oncology", "reqid": "15630BR", "state": null, "state_short": null, "location": "Field Based, BEL", "uid": 28737817}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15711BR\nJob Posting Title Medical Information Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This professional will be responsible for working within Medical Information in the Scientific Affairs organization and will be involved with communicating product information to internal and external customers. This position offers an opportunity to work in a matrix environment on a cross-functional team that is focused on supporting Amgen\u2019s innovative scientific programs.\n\nPrimary responsibilities include providing verbal and written clinical and technical information to internal and external customers as it relates to Amgen\u2019s inflammation products; facilitating intake and documentation of adverse events and product complaints as they relate to Amgen products; conducting literature reviews and analyses around the potential impact to the business; monitoring and reviewing the literature to identify competitive issues.\n\nAdditional responsibilities will include developing key deliverables in support of Amgen inflammation products; providing clinical support to other Amgen departments; developing and/or participating in training programs; supporting Amgen customers at major scientific meetings.\n\nKey deliverables and activities include the development of medical information letters; development of Clinical FAQs to be used by the MedInfo healthcare professional staff, regional medical liaisons and/or call center representatives; developing key literature surveillance outputs to ensure timely communication of key data across Amgen; and training vendor HCP staff on data and processes.\nBasic Qualifications ?Doctorate degree\nOR\n?Master\u2019s degree & 3 years of directly related experience\nOR\n?Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Prior experience in Medical Information / Drug Information is strongly preferred. Two or more years of biotech/pharmaceutical and/or clinical experience are also preferred. Knowledge and understanding of clinical and therapeutic issues relevant to Rheumatology and Dermatology preferred.\nStrong verbal and written communication skills are required along with the ability to work in a matrix environment, across multiple teams. Proven scientific literature analysis and evaluation skills; organizational and project management skills, technical writing skills; computer literacy; and the ability to manage a large number of complex projects simultaneously.", "date_new": "2012-05-16 19:08:46", "url": "http://www.amgen.jobs/xml/28737812/job", "country": "United States", "company": "Amgen", "title": "Medical Information Mgr", "reqid": "15711BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28737812}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15349BR\nJob Posting Title Dir Information Systems (Quality Lab Systems)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Director of Information Systems Quality Lab Systems (within OIS) will be responsible for the successful management and execution of all the IS activities supporting the Quality Control (QC) within the Operations Quality organization.  The key focus area will be the leadership and management of our Quality Lab Systems Portfolio, which includes LIMS with Stability Management, LMES (Electronic Notebook) with Consumable Inventory Management, and CDS systems. The person in this role will lead the Corporate Quality Lab IS team that supports the AMGEN QC Network globally. The person will have direct client executive relationship management responsibility with Amgen Corporate QC executive as primary client, as well as site business executives as stakeholders of the delivered systems and solutions. This person will become part of the overall Global OIS Leadership team and will have opportunities to lead strategic issues and/or to help influence corporate/global wide directions within OIS.\nThis position will be based in Thousand Oaks, California and travel at various times is anticipated to be approximately 20% to support globally distributed staff and portfolio execution.\nSpecific Responsibilities are:\n\u2022 The Director will manage a staff of Lab Systems Analyst distributed globally across Amgen locations, in delivery of Lab Systems services utilizing and enhancing the Lab Systems Global Delivery Model and Business Practices. The Lab Systems portfolio spans across both Commercial and Clinical areas and includes a mix of facility expansions, systems upgrades and new construction projects. Oversight responsibilities will include individual project governance with stakeholders and service providers including business case justification, scope, schedule, resourcing, application of technology, reporting as well as portfolio level demand management, resourcing, reporting and prioritization with clients.\n\u2022 This person will be responsible for developing and driving the overall global Quality Lab Systems Project Portfolio, including the governance and budget strategies that can deliver the global portfolio.\n\u2022 This person will also be responsible for developing and driving a global IS Support Model (for day-to-day operations, software product roadmap, and life-cycle management) for the lab systems; one that will leverage the existing Global external partnerships, IS network and staff at each of the major Operations sites.\n\u2022 The candidate must be able to influence the development of business area strategy where appropriate and be expected to partner with key stakeholders to drive the lab systems roadmap and its\u2019 evolution looking ahead to Quality\u2019s strategy.\n\u2022 The individual will develop and chair the Amgen\u2019s Lab Systems network through a cross site and cross functional team setting, and will participate in several Global QC forums representing the voice of Amgen Lab Systems network.\n\u2022 The individual will also manage key strategic supplier relationships from both product and services side as required.\n\u2022 The individual will ensure compliance with Amgen and industry practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies with supporting documentation and monitoring.\n\u2022 Continuously drive improvement processes & governance for IS in support of QC organization\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience OR\n\u2022Master\u2019s degree & 8 years of directly related years experience OR\n\u2022Bachelor\u2019s degree & 10 years of directly related experience\n\n\u2022 AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Advanced degree in Computer Science, Engineering, Life or Physical Sciences, or Business (MBA)\n\u2022 12+ years of biopharma experience with 15+ years experience in operations/manufacturing/clinical manufacturing/IS, including cGMP regulated environments\n\u2022 5 years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development.\n\u2022 Experience working cross-functionally and building collaborative working relationships; interfacing effectively with Operations and IS Senior and Executive Management to resolve issues\n\u2022 Excellent communication capabilities vertically and horizontally.\n\u2022 Ability to deal with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making\n\u2022 Certified or experience in process improvement methodologies such as Lean/Six Sigma\n\u2022 Facilitation/ Planning / Negotiation / Coaching & Project Management skills\n\u2022 Results oriented, strong adherence to timelines and ability to maneuver in large corporate setting\n\u2022 Excellent ability to translate knowledge and build high performing teams\n\u2022 Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation.\n\u2022 Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering.\n\u2022 ERP experience is a plus.", "date_new": "2012-05-16 19:08:38", "url": "http://www.amgen.jobs/xml/28737808/job", "country": "United States", "company": "Amgen", "title": "Dir Information Systems (Quality Lab Systems)", "reqid": "15349BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28737808}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15701BR\nJob Posting Title Scientist - Analytical Research and Development\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen\u2019s Analytical Research and Development (AR&D) organization seeks an outstanding scientist to support our clinical pipeline and commercial activities at our Thousand Oaks, CA facility.\n\nKey responsibilities for this incumbent will include the development and application of traditional and novel enabling analytical approaches through the use of, for example, chromatographic, spectroscopic, and solid-state methodology used during, and support of, drug substance/product development and manufacturing.\n\nOther responsibilities also include investigating, recommending, developing, and driving the implementation of analytical enabling workflows with automation and information technology. The successful candidate will also participate in and contribute on multi-disciplinary project and technology teams across a matrix organization.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 6 years of scientific experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of scientific experience\nPreferred Qualifications \u2022 Ph.D. degree, or equivalent, in analytical chemistry, chemistry, pharmaceutical sciences, biochemistry, or related field\n\u2022 Excellent written and oral communication skills are required for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment.\n\u2022 Strong abilities in trouble-shooting, problem-solving, data review and interpretation, and multi-tasking\n\u2022 Theoretical and practical understanding and experience in wet chemistry, separation/spectroscopic sciences and associated instrumentation\n\u2022 Understanding of laboratory automation and information technology\n\u2022 Familiarity with drug substance/product development and manufacturing", "date_new": "2012-05-16 19:08:01", "url": "http://www.amgen.jobs/xml/28737796/job", "country": "United States", "company": "Amgen", "title": "Scientist - Analytical Research and Development", "reqid": "15701BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28737796}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15705BR\nJob Posting Title CDM Systems Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Serve as primary point-of-contact to coordinate and lead comprehensive and holistic Clinical Data Management system services to Data Management Therapeutic teams.\n\nThe Manager of Client System Services \u2013 CDM Systems Interface (CSI) role will ensure the proper, timely, and successful setup and implementation of clinical data management services during study startup, study maintenance, and study closeout for individual study teams. The CSI will ensure the most effective use, implementation, and observance of systems and data standardization, and status of CDM System services including but not limited to EDC, clinical trial database programming deliverables, including database, edit check, custom report programming, CDM Systems lab administration, CDM SAS programming deliverables, including data transfer plans, electronic data load, lab range entry, lab data review, IVRS, IWT, and SAS macros and other clinical data management activities according to study startup timelines in a regulatory compliant manner.\n\nThis position is expected to partner effectively with other CDM System team members to seamlessly ensure high quality deliverables serving as the primary point of contact as a program management function to the systems and technology setup and operations supporting study management activities. The CSI is expected to ensure and support continuous global operations of Amgen\u2019s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization.\nMentor and support junior staff\n\u2022 Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines.\n\u2022 Procurement and program management of resources, timeline, and services from both internal and external service providers\n\u2022 Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology\n\u2022 Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers\n\u2022 Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives\n\u2022 Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished\n\u2022 Develop strong relationship with external providers (such as FSP and Vendor Provider) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT\n\u2022 Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery\n\u2022 Previous experience working in a global environment\n\u2022 Previous Data Manager in clinical development setting or study team related experience\n\u2022 Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable\n\u2022 Work experience implementing other clinical technologies including but not limited to IVRS, IWT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary\n\u2022 Knowledge of ITIL v3 and basic Industry IS best practices\n\u2022 Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills\n\u2022 Excellent time management and organization skills required\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\u2022 Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable", "date_new": "2012-05-16 19:07:37", "url": "http://www.amgen.jobs/xml/28737777/job", "country": "United States", "company": "Amgen", "title": "CDM Systems Mgr", "reqid": "15705BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28737777}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15677BR\nJob Posting Title Specialist IS Architect - Unified Communications - Microsoft Lync / Cisco\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\n\nService Manager responsible for defining, developing the delivery and the support of the Unified Communication technologies at Amgen. A key deliverable will be developing a long term roadmap for the deployment of Unified Communications (UC) at Amgen.\n\nDaily oversight and operations of Amgen\u2019s Unified Communications Services and infrastructure, resolution of escalated Service issues and oversight and guidance of Level 2 support staff. Candidate will operate from Amgen\u2019s Thousand Oaks, California, location. A critical part of the role will be to ensure operational support is defined and implemented in the most effective and efficient manner.\n\nJob Responsibilities\n\n\u2022 Owner of the UC Service delivery strategy\n\u2022 Define and Communicate to staff the UC Service\u201d\no Ensure training and education is available and in place.\n\u2022 Responsible for defining, maintaining and roll out of the UC strategy roadmap\no Define UC equivalent operational model of existing services\no Development and implementation of roadmap for 2012\n\u2022 Responsible for the delivery and support of the Lync IM and Presence service globally\no Define/enhance current operational support model\n\u2022 Responsible for the delivery and support of the UC Enterprise Voice and Conferencing service to existing pilot projects.\no Plan for future expansion based on roadmap.\no Plan to enhance current operational support model based on expansion\n\u2022 Develop and maintain Service Catalog description of the Service\n\u2022 Communication and promotion of the service to clients to ensure use cases are identified to ensure the service continues to meet client needs\n\u2022 Financial responsibility for Operational/Project budget\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 College Graduate, preferably in Telecommunications, Networking or Computer Sciences\n\u2022 Minimum 10 years experience PBX/VOIP including Nortel and Cisco environments\n\u2022 Management of project teams of 5 or more staff\n\u2022 Delivery of Telecom/VOIP services to 30,000+ environment\n\u2022 Minimum 3 years Microsoft Lync IM and Presence, Video and VOIP experience\n\u2022 Minimum 3 years Unified Communications and collaboration including Lync or Cisco call center manager\n\u2022 Minimum 3 years experience working in Biotechnical, Pharma or related industry\n\u2022 Minimum 5 years experience with call center solutions\n\u2022 Minimum 5 years project management or direct management responsibilities\n\u2022 Strong written and verbal communications skills, including the ability to converse with both technical and non-technical users\n\u2022 Working knowledge of Word, Excel, Outlook, SharePoint, File Maker Pro, Visio and other standard\u201d business software platforms", "date_new": "2012-05-16 19:06:30", "url": "http://www.amgen.jobs/xml/28737717/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Architect - Unified Communications - Microsoft Lync / Cisco", "reqid": "15677BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28737717}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15721BR\nJob Posting Title Finance Mgr\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Hybrid position supporting both Partnership and G&A FP&A teams. This role will provide financial oversight, analyses and management reporting of (1) external alliances to forecast partnership revenues and expenses and (2) functions within the G&A organization to forecast operating budgets and headcount. Job functions include, but not limited to the following:\n\nPartnership Responsibilities\n\u2022Work closely with Amgen staff and external representatives to prepare detailed financial modeling and analysis to support strategic planning, negotiations and operational decision making. This includes working with Finance, Accounting, Corporate Development, Alliance Management, Legal, Tax, Treasury and Operations/R&D personnel.\n\u2022Review and become a content expert for external alliance agreements. Provide guidance when questions arise as to why and how costs are accounted for, billed and forecasted.\n\u2022Ensure milestones associated with partnerships are planned for and managed appropriately through an existing database tool.\n\u2022Manage royalty expense and income forecasts via input from Legal and Accounting.\n\nG&A Responsibilities\n\u2022Lead financial expense planning processes such as the monthly Close, Latest Estimates, and annual Planning activities including headcount management.\n\u2022Prepare, analyze and present operating expense results for various department managers and communicate expense plans and results.\n\u2022Prepare standard and ad hoc expense analyses including headcount related costs and outside expenses.\n\u2022Provide client support as needed\nBasic Qualifications Doctorate degree OR Master\u2019s degree & 3 years of experience directly related to the job OR Bachelor\u2019s degree & 5 years of experience directly related to the job OR Associate\u2019s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications -MBA and/or CPA\n-5+ years experience in Financial Planning & Analysis and/or Accounting\n-Prior work experience in, and understanding of, pharmaceutical business\n-Demonstrated leadership capability and team leader/player skills\n-Strong analytic, organization, problem-solving and communication skills\n-Working knowledge of Cognos PowerPlay, TM1, GPS and SAP applications.\n-Excellent Excel and PowerPoint skills", "date_new": "2012-05-15 20:55:36", "url": "http://www.amgen.jobs/xml/28712276/job", "country": "United States", "company": "Amgen", "title": "Finance Mgr", "reqid": "15721BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28712276}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15715BR\nJob Posting Title Sr Exec Assistant\nCareer Category Administrative\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Reporting to the VP of Oncology Sales, the Senior Executive Assistant (SEA) will be responsible for performing senior level administrative support. The SEA\u2019s administrative and project work assignments will be complex in nature requiring absolute discretion, as well as considerable tact, judgment, creativity and initiative in resolving issues. The SEA must also be able to manage multiple priorities in a continually changing environment.\n\nThis role will also be responsible for the orderly establishment, maintenance and retrieval of filed information and correspondence, composing and editing correspondence on behalf of the Vice President, maintaining calendars, scheduling appointments and coordinating arrangements for meetings, and coordinating domestic and international travel.\n\nSpecific responsibilities of this position include helping to organize workflow by reviewing and managing correspondence sent to the executive; screening and directing incoming calls/correspondence/visitors; and answering questions/providing information when appropriate.\n\nThis SEA will process expense reports, gather data from a variety of sources for inclusion into technical reports and presentations, perform independent research and prepare information for special projects as assigned.\nBasic Qualifications Associate\u2019s degree & 4 years of experience directly related to the job OR High school diploma / GED & 6 years of experience directly related to the job\nPreferred Qualifications \u2022 Bachelor\u2019s degree\n\u2022 Strong project management experience\n\u2022 Executive assistance experience\n\u2022 Strong technical knowledge and experience especially with Amgen\u2019s internal infrastructures (Microsoft Vista, Sharepoint, SAP, Cognos, IS Online Service Request, Help Desk; Concur/Expense Reporting; Concur Carlson Wagonlit Travel; e-Finity)\n\u2022 Exceptional communication skills \u2013 oral and written\n\u2022 Team Player\n\u2022 Honed leadership skills\n\u2022 Outstanding interpersonal skills\n\u2022 Excellent Microsoft suite ability\n\u2022 Excellent time management and project management skills\n\u2022 Innovative, creative, flexible", "date_new": "2012-05-15 20:54:13", "url": "http://www.amgen.jobs/xml/28712214/job", "country": "United States", "company": "Amgen", "title": "Sr Exec Assistant", "reqid": "15715BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28712214}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15729BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Fort Worth, TX\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Texas\nLocation (City) Field Based\nAmgen Job Description Territory #33707 - Fort Worth covering Arlington, Abilene, Midland, Odessa, San Angelo\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-05-15 20:52:39", "url": "http://www.amgen.jobs/xml/28712130/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Fort Worth, TX", "reqid": "15729BR", "state": "Texas", "state_short": "TX", "location": "Field Based, TX", "uid": 28712130}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15693BR\nJob Posting Title Health Economics Sr Mgr - Nephrology\nCareer Category Health Economics\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Develops scientific evidence to support global value and access strategies for Amgen products in Nephrology therapeutic area\n\nResponsibilities:\n1. Develops Global and Regional value propositions\n2. Develops economic models (cost effectiveness, budget impact, etc) and conducts analyses of existing data, both independently and in collaboration with vendors and key opinion leaders.\n3. Develops annual strategic plans and research projects that support the value proposition including outcomes research, patient reported outcomes, and health economics modeling\n4. Creates and maintains the Global Value Dossier\n5. Performs health economics projects from inception to completion and publication including creation of Study Concept Documents, Protocols, Analysis Plans, Study Reports, abstracts and manuscripts\n6. Reviews and critiques medical and evidence-based outcomes literature\n7. Manages researchers and health economics vendors external to the company, including scientific guidance, contracting, and budgets\n8. Works with clinical and commercial teams to create and implement payer, value and publication plans, and to provide inputs into clinical development programs including payer endpoints and PROs design and analysis\n9. Interacts with and presents to multiple departments within Amgen, both in the US and internationally, including health economics, clinical development, biostatistics, observational research, commercial, brand teams, payer and pricing\n10. Builds relationships with Key Researchers and Opinion Leaders\nBasic Qualifications - Doctorate degree & 2 two years of directly related experience\nOR\n- Master\u2019s degree & 6 six years of directly related experience\nOR\n- Bachelor\u2019s degree & 8 years of directly related experience\nPreferred Qualifications - PhD in Health Economics, Epidemiology, Outcomes Research, Health Services Research\n- 4 or more years of experience in global outcomes research including dossier submissions for reimbursement\n- 3 or more years of experience developing economic models and conducting observational research e.g. in claims data\n- 3 or more years of experience in PRO/HRQOL research including questionnaire design, evaluation, and/or analysis\n- Direct experience in economic modeling, statistical analysis, and observational research", "date_new": "2012-05-15 20:52:38", "url": "http://www.amgen.jobs/xml/28712129/job", "country": "United States", "company": "Amgen", "title": "Health Economics Sr Mgr - Nephrology", "reqid": "15693BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28712129}, {"country_short": "USA", "city": "West Greenwich", "description": "Auto req 15708BR\nJob Posting Title Sr Mgr Information Systems (Automation)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen Job Description The Sr Mgr IS - Automation leads a group of engineers to provide automation technical and engineering support for the 24x7 manufacture of biopharmaceuticals. This individual will define automation strategy and manage the automation team to deliver high quality requirements, design, implementation, commissioning, qualification, operation and maintenance of computer related systems to meet business expectations in a GAMP and cGMP compliant manner.\n\nResponsibilities include:\n\n\n- Establishing strategy and direction for automation in support of strategic business needs as it pertains to multiproduct commercial and clinical biopharmaceutical manufacturing.\n- Providing direct and indirect supervision of full time staff plus supplemental contractors as needed to support project activities.\n- Working with engineering, process development, manufacturing and quality groups to provide support for the design, installation, start-up, validation and operation of facility and/or process equipment.\n- Supporting the ongoing enhancement and optimization of automation systems by using a cGMP change management and software development lifecycle approach.\n- Providing solutions to a wide range of difficult problems by applying industry wide knowledge in the development of automation systems.\n- Translating strategic business needs into a project methodology framework.\n- Driving continuous improvement and high reliability performance by building a culture of innovation, organizational learning and zero defect thinking.\n- Managing non-conformance, corrective and preventive actions for automation systems.\n- Providing direction and resource prioritization relative to multiple projects, programs and on-going initiatives.\n- Guiding the successful completion of complex projects by applying extensive technical and managerial expertise in the design, maintenance and alteration of automation systems to meet scope, schedule, quality and management strategic objectives.\n- Interacting with senior internal and external personnel, often requiring coordination between organizations.\n- Understanding regulatory trends in industry. Direct experience with FDA or equivalent regulatory body is required. Acts as the primary automation technical lead during internal and external audits.\n- Providing 7x24 escalation support for major manufacturing automation issues.\n- Other functions may be assigned.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience OR\n\u2022 Master\u2019s degree & 6 years of directly related experience OR\n\u2022Bachelor\u2019s degree or & 8 years of directly related experience OR\n\u2022 Associate\u2019s degree & 10 years of directly related experience OR\n\u2022 High school diploma / GED & 12 years of directly related experience\n\u2022 AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Advanced degree in Engineering or Life Science.\n\n\u2022 8+ years of biopharma experience with 5+ years experience in operations/manufacturing, to include cGMP regulated, Delta V process control/automation.\n\n\u2022 4+ years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development.\n\n\u2022 Technical expertise with batch process control systems and industry standards, including ISA S88, S95 and GAMP. Familiarity with DCS, MES, BAS and PLC/SCADA systems.\n\n\u2022 Demonstrated skill in the practical application of Engineering principals and Project Management techniques.", "date_new": "2012-05-15 20:52:36", "url": "http://www.amgen.jobs/xml/28712128/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Information Systems (Automation)", "reqid": "15708BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 28712128}, {"country_short": "TUR", "city": "Istanbul", "description": "Auto req 13822BR\nJob Posting Title Sr Associate Human Resources\nCareer Category Human Resources\nEmployee Subgroup Salaried FT\nCountry (State/Region) Turkey\nLocation (City) Istanbul\nAmgen Job Description Ensures job descriptions for all positions are written and agreed with line management and HR\nManages the recruitment processes in partnership with line management\nConducts HR programs such as orientation, recruiting events, employee relations meetings\nCoordinates on-boarding, hiring and payroll processess\nCreates training plan in order to develop employees\u2019 skills\nEnsures HR programs are communicated and understood by employees\nImplements international HR policies and procedures\nManages day-to-day relationship with external suppliers/vendors\nFacilitates communication between individuals and departments/business units\nSupports performance management processes\nEnsures compliance with local labor laws through review of work contracts and status changes\nEnsures accurate and compliant pay and benefits administration\nConducts annual competitive benchmarking analysis and other HR reports for the site\nBasic Qualifications University Degree: HR, Business or similar\n3 to 5 years of related industry experience\nKnowledge of recruitment, communication, training process\nFluency in English, both in oral and written communication\nComputer skills\nPreferred Qualifications Minimum 3 years of experience in HR\nExperience in multinational pharmaceutical company", "date_new": "2012-05-14 18:35:07", "url": "http://www.amgen.jobs/xml/28674621/job", "country": "Turkey", "company": "Amgen", "title": "Sr Associate Human Resources", "reqid": "13822BR", "state": null, "state_short": null, "location": "Istanbul, TUR", "uid": 28674621}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15659BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - Houston West\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Texas\nLocation (City) Field Based\nAmgen Job Description Territory:(#17411) Houston West, TX - covering - West Houston from but not including the medical center, Lake Jackson, Pearland, Richmond, Wharton, Katy\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-05-14 18:35:06", "url": "http://www.amgen.jobs/xml/28674620/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - Houston West", "reqid": "15659BR", "state": "Texas", "state_short": "TX", "location": "Field Based, TX", "uid": 28674620}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15656BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - San Antonio South\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Texas\nLocation (City) Field Based\nAmgen Job Description Territory:(#17418) San Antonio South, TX - covering - Brownsville, Laredo, Harlingen, McAllen, Corpus Christi, Victoria, South San Antonio\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-05-14 18:34:44", "url": "http://www.amgen.jobs/xml/28674613/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - San Antonio South", "reqid": "15656BR", "state": "Texas", "state_short": "TX", "location": "Field Based, TX", "uid": 28674613}, {"country_short": "CAN", "city": null, "description": "Auto req 15518BR\nJob Posting Title Scientist - Biologics Discovery\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) Canada\nLocation (City) Burnaby\nAmgen Job Description Amgen\u2019s Therapeutic Discovery (TD) organization seeks an experienced and outstanding Scientist to support the Biologics Discovery efforts undertaken at Amgen British Columbia.\n\nAmgen\u2019s research facility located in Burnaby, British Columbia, Canada is focussed on the use of XenoMouse technology for the generation and characterization of therapeutic antibody panels.\n\nThe successful employee will be responsible for providing scientific leadership and participate in the strategic design of the screens used to select best-in-class therapeutic molecules, by leveraging experience in large molecule pharmacodynamics, pharmacokinetics and biophysical interactions.\n\nIn addition, this scientist will develop and carry out biochemical characterization screens utilizing BiaCore, KinExA, ForteBio and other common platform screening technologies. A core component of this role will be the development of novel and innovative screening methods to interrogate properties of molecules which will aide the selection of the best drug candidate panels.\n\nThe successful incumbent also will develop high throughput screening, binding assays and innovative platform technologies that enable the selection of best therapeutic drug panel.\n\nOther responsibilities will include working locally and cross-site with scientists within other functional areas of the Therapeutic Discovery department and the greater Discovery Research organization to develop therapeutic design goals and recommendations on the best strategy for identifying the molecule of interest.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 6 years of scientific  experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of scientific experience\nPreferred Qualifications \u2022 Ph.D. degree, or equivalent, in biochemistry, analytical chemistry, biophysics, pharmaceutical sciences, chemistry, or related field with 3-5 years of postgraduate research experience\n\u2022 Large molecule drug development experience with an emphasis on pharmacokinetics and biophysical interactions.\n\u2022 Theoretical and practical understanding and experience in wet biochemistry, assay development and screening, and associated instrumentation with special skill sets in Biacore, ForteBio and KinExA\n\u2022 Experience with laboratory automation and information technology\n\u2022 Strong abilities in trouble-shooting, problem-solving, data review and interpretation, and multi-tasking\n\u2022 Excellent written and oral communication skills.\n\u2022 Enthusiasm for working in a fast-paced, multi-disciplinary, team-based environment", "date_new": "2012-05-14 18:34:21", "url": "http://www.amgen.jobs/xml/28674601/job", "country": "Canada", "company": "Amgen", "title": "Scientist - Biologics Discovery", "reqid": "15518BR", "state": null, "state_short": null, "location": "Virtual, CAN", "uid": 28674601}, {"country_short": "TUR", "city": "Istanbul", "description": "Auto req 15170BR\nJob Posting Title Sr Biopharmaceutical Rep\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Turkey\nLocation (City) Istanbul\nAmgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2012-05-14 18:33:19", "url": "http://www.amgen.jobs/xml/28674573/job", "country": "Turkey", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "15170BR", "state": null, "state_short": null, "location": "Istanbul, TUR", "uid": 28674573}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15682BR\nJob Posting Title Disbursements Shared Services Manager\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Responsible for the assessment and development of training strategies for Global Expense Report area (Accounts Payable and Payroll) Effectively plan, coordinate and conduct necessary training as required to ensure best in class customer support Responsible for developing and executing client outreach strategies domestically and internationally Successfully manage and cultivate key client relationships to ensure that Staff Expense Management objectives are met in a cost-effective and timely manner Lead effort to translate the needs of key clients into training programs and drive communication in support of projects and other key initiatives Responsible for training documentation and measuring the effectiveness of training through metrics and other tracking methodology Responsible for strategic business partnering with key clients; including participating in work streams for process improvement initiatives Responsible for electronic expense report system implementation; including program communications, training and change management Travel domestically and internationally up to 20% per year\nBasic Qualifications Doctorate degree OR Master\u2019s degree & 3 years of experience directly related to the job OR Bachelor\u2019s degree & 5 years of experience directly related to the job OR Associate\u2019s degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications Advanced degree / certification such as Accounts Payable Professional (CAPP), CPA , CMA, MBA is desired 5 years of progressive operational experience in expense reporting, accounts payable, payroll, purchasing, finance, accounting, and / or auditing Experience with ERP systems (SAP) Experience with electronic expense reporting sytems (Concur is preferred) Strong, proven management, leadership, and communication skills (written and oral) Strong presentation skills Advanced public speaking skills Minimum of 2 years leading global project teams Proficient in Microsoft Word, Excel, Power Point Knowledge and understanding of procurement to pay process is desirable Excellent and insightful analytical skills; ability to be decisive, build teams and provide leadership Excellent business acumen (e.g., knowledge of business drivers, finding solutions and knowledge of accounting, finance and other business areas) Advanced skills in Microsoft Visio and Access Multilingual", "date_new": "2012-05-14 18:32:14", "url": "http://www.amgen.jobs/xml/28674548/job", "country": "United States", "company": "Amgen", "title": "Disbursements Shared Services Manager", "reqid": "15682BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28674548}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15570BR\nJob Posting Title Scientist \u2013 Clinical Immunology\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Scientist for our Medical Sciences / Clinical Immunology group will be responsible for the design and execution of specific scientific experiments for the development and implementation of methods in cell biology and immunology as supported by flow and imaging cytometry/microscopy platforms. This includes that development and implementation of novel approaches and protocols that are more sensitive, of higher throughput and/or of decreased cost. This includes the ability to conduct data analysis and interpretation, and assess impact of the data on a given projects as well as the ability to provide technical support and expertise to department operating groups when needed. The scientist in this role will represent the group on cross-functional project teams and will have the ability to contribute as lead author on scientific documents such as journal publications, technical reports, etc.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 6 years of scientific  experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of scientific experience\nPreferred Qualifications The ideal candidate should have the following:\n\nQualifications and experience:\n\n\u2022 PhD in Life Sciences or related field with 2 plus years of relevant laboratory experience\n\u2022 Or, Master's degree in Life Sciences or related field, or Medical Technologist certification (with Bachelor's) with 8 or more years of relevant laboratory experience\n\nGeneral Knowledge:\n\n\u2022 Demonstrated innovation in cell biology, flow or imaging cytometry/microscopy.\n\u2022 The ability to solve complex problems, demonstrating a deep understanding in a scientific area of expertise.\n\u2022 A demonstrated ability to drive scientific excellence and innovation.\n\u2022 Knowledge of the drug development process.\n\u2022 The ability to effectively present scientific information both internally and externally to influence decisions and/or scientific practices.\n\nSpecialized Knowledge:\n\n\u2022 In depth knowledge of fluorescence probes as they relate to a multiplexed assay design.\n\u2022 In depth knowledge of at least one pertinent cytometry platform (flow cytometry, high content imaging cytometry, microscopy) and how it may be applied to experiments in the field(s) of Immunology, Hematology, Oncology, Neurology, etc.\n\u2022 The ability to work with cell lines, whole blood and tissue specimens from animals and humans.\n\u2022 Project Management as it pertains to multi-tasking and charting the course to meet timelines.\n\nIn addition these general competencies are highly desirable:\n\n\u2022 Ability to communicate complex ideas to audiences with varying degrees of knowledge.\n\u2022 Initiative.\n\u2022 Attention to detail.\n\u2022 Independence of thought demonstrated through hypothesis formulation, experimental design, interpretation and innovation.\n\u2022 Demonstrated critical thinking with an ability to integrate data and information to solve complex problems.\n\u2022 Ability to balance collaboration on a functional and/or cross-functional team as a leader and/or a member against hands-on experimentation in the laboratory.", "date_new": "2012-05-14 18:32:09", "url": "http://www.amgen.jobs/xml/28674545/job", "country": "United States", "company": "Amgen", "title": "Scientist \u2013 Clinical Immunology", "reqid": "15570BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28674545}, {"country_short": "TUR", "city": "Istanbul", "description": "Auto req 15495BR\nJob Posting Title Training & Development Mgr\nCareer Category Training\nEmployee Subgroup Salaried FT\nCountry (State/Region) Turkey\nLocation (City) Istanbul\nAmgen Job Description This role is responsible for development, coordination and execution of field training for the BHBU, including New Hire Training, Semester Meeting Training, curriculum review, and ongoing clinical and skill training. Individual will be a liaison with the BHBU Sales and Marketing teams to evaluate and identify training needs based on strategic plan, and develop and implement training to reflect those needs. Individual will work with business unit to effectively develop and deliver training solutions that have universal application. Review and assist with developing and updating training modules, field training curriculum, training exams and role play scenarios. Work with BU and Sales Operations to train on automated customer management system and sales reporting tools. Interface with Sales and Marketing team to understand brand strategy and goals. Responsible for translating national brand plan, and its tactics into training curriculum/content for new hire training execution. Responsible for MAC review of training materials in conjunction with marketing. Prepare, coordinate, and facilitate training with field leadership and guest trainers. Establish training metrics/assessments to measure performance during phase 1 and 2 new hire curriculum and report findings to sales leadership. Develop/facilitate additional POA training as requested by Strategic Training Managers. Interface with Strategic Training Manager group to provide new hire curriculum updates.\nBasic Qualifications Doctorate degree OR Master\u2019s degree & 3 years of experience directly related to the job OR Bachelor\u2019s degree & 5 years of experience directly related to the job\nPreferred Qualifications Bachelor\u2019s degree. 3 years of biotech or pharmaceutical selling experience. Ability to travel 50-75% of the time. Documented ability to consistently achieve or exceed sales goals. Demonstrate strong communication, leadership, and presentation/facilitation skills. Able to influence and build cross-matrix relationships. Strong analytical and technical skills, creative problem solving, and excellent oral, written and interpersonal skills.", "date_new": "2012-05-14 18:32:00", "url": "http://www.amgen.jobs/xml/28674543/job", "country": "Turkey", "company": "Amgen", "title": "Training & Development Mgr", "reqid": "15495BR", "state": null, "state_short": null, "location": "Istanbul, TUR", "uid": 28674543}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 15679BR\nJob Posting Title Sr Associate (Purification)\nCareer Category Process Development\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - Washington\nLocation (City) Seattle\nAmgen Job Description The candidate will be a member of the Purification Process Development (PPD) department. Candidate will be part of a technical team involved in product recovery and purification process development of monoclonal antibodies and other proteins.\n\nWork will involve bench and pilot scale process and technology development activities in the areas of harvest clarification, chromatography, and/or filtration. Technology transfer to pilot, clinical and commercial manufacturing as well as data documentation will be aspects of this job.\nBasic Qualifications - Master\u2019s degree, or will have obtained degree by August 2012\nOR\n- Bachelor\u2019s degree & 2 years of directly related experience\nOR\n- Associate\u2019s degree & 6 years of directly related experience\nOR\n- High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications - Master\u2019s degree in Biochemistry, Chemical Engineering or scientific field\nOR\n- BS in Biochemistry, Chemical Engineering or scientific field and 3+ years in purification process development\n- Experience in product recovery/clarification, chromatography, filtration, and/or high throughput screening (HTS) technologies\n- Experience in developing purification processes for clinical and/or commercial manufacturing\n- Ability to work well in a team environment\n- Excellence in communication skills \u2013 both verbal and written", "date_new": "2012-05-13 20:34:33", "url": "http://www.amgen.jobs/xml/28663965/job", "country": "United States", "company": "Amgen", "title": "Sr Associate (Purification)", "reqid": "15679BR", "state": "Washington", "state_short": "WA", "location": "Seattle, WA", "uid": 28663965}, {"country_short": "CAN", "city": null, "description": "Auto req 15700BR\nJob Posting Title Sr Associate Contract Management (Contract)\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) Canada\nLocation (City) Mississauga\nAmgen Job Description Position: Senior Associate Clinical Contracts & Budgets\nReports to: Manager, Clinical Research Services\nGrade: 4\nStarting:August 2012 (13-month maternity-leave contract)\nLocation: Head Office, Mississauga\n\nInternal Candidates are required to have a discussion with their current manager regarding intent to apply.\n\nJob Purpose:\n\nTo manage all site-related contracting and budget negotiations and to process and track related payments in a timely and efficient manner.\n\nKey Job Functions:\n\n\n1. Negotiates contract with clinical trial site, responding to comments within defined parameters set (produced by Legal) and seeking legal input for issues outside parameters set\n\n2. Leads the review of the budget template with local project manager for country feedback on FMV (Fair Market Value) and the Schedule A template\n\n3. Negotiates site budget from the base budget and payment milestones using appropriate guidelines\n\n4. Escalates contract/budget issues to Legal, Pricing, and/or local & global study manager as appropriate\n\n5. Coordinates and participates in meetings with site/legal to resolve contract issues\n\n6. Manages, executes and reconciles payments ensuring that spending is within approved contract budgets\n\n7. Maintains contract and payment data tracking in appropriate databases and financial systems\n\n8. Manage internal stakeholder needs and expectations through regular communication regarding progress/status of pending contract and payment requests.\n\n9. Actively contributes to results-oriented global and local departmental goals\n\n10. Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness\nBasic Qualifications Qualifications/Experience\n\n\u2022 Bachelor\u2019s degree in a science or business field\n\u2022 3-5 years or more related experience in finance administration, project management, contracting or other relevant work experience in life sciences or medically related field\n\u2022 Work experience in clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO is preferred.\n\nCompetencies\n\n\u2022 Ability to work independently with little supervision as well as in a team environment\n\u2022 Strong Negotiation skills\n\u2022 Strong analytical and presentation skills\n\u2022 Excellent written and oral communication skills\n\u2022 Attention to detail\n\u2022 Persistent, tactful and persuasive\n\u2022 Proficiency with computer/database systems\n\u2022 Strong organizational skills with the ability to manage multiple priorities", "date_new": "2012-05-11 18:20:30", "url": "http://www.amgen.jobs/xml/28633380/job", "country": "Canada", "company": "Amgen", "title": "Sr Associate Contract Management (Contract)", "reqid": "15700BR", "state": null, "state_short": null, "location": "Virtual, CAN", "uid": 28633380}, {"country_short": "AUS", "city": "Brisbane", "description": "Auto req 15688BR\nJob Posting Title Sr Biopharmaceutical Rep - Qld North (Bone)\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Australia\nLocation (City) Brisbane\nAmgen Job Description Part time (4 days per week) permanent role, based in Queensland, Australia. Territory: Queensland North.\nReporting to the National Sales Manager(Bone).\n\nAccountabilities:\n- Maximizes revenue and market share of Amgen\u2019s products in territory and achieves/exceeds sales targets.\n- Develops and maintains in-depth knowledge of the product, market and stakeholders\n- Collaborates with manager to implement agreed Plan of Action in line with marketing strategy and works within agreed budgets.\n- Establishes and manages high quality customer relationships\n- Establishes and manages effective relationships with territory partners\n- Proactively collaborate with a team of GP representatives to build an advocacy cascade to primary care through meetings\n\nResponsibilities:\nTerritory Analysis & Planning:\n- Collaborates with manager and territory partners to develop and implement territory Plan of Action and key account plans\n- Collaborates with relevant stakeholders (Medical /Key Account Manager, Territory Partner, GP team) to agree on key account/primary care plan objectives/responsibilities\n- Evaluates progress vs. plan monthly, and agrees to course corrections with manager where necessary\n- Provides feedback to product/sales management on competitor activity\n\nCustomer Relations and Clinical Selling:\n- Develops and maintains up-to-date customer/key account/market understanding\n- Details products in accordance with Amgen\u2019s sales process (Performance 4) and agreed marketing strategy\n- Continuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs and mentors GP team\n- Build and maintain long-term associations with physicians and other health care professionals based on trust\n\nOrganization & Administration:\n- Proactively Reports customer activity in the CRM system and ensures customer profiles are kept up-to-date\n- Operates within the agreed expense budget\n- Follows up on customer queries in a timely manner\n\nCollaboration:\n- Ensures open communication and shares best practices, is in close collaboration with the rest of the team, actively exchanging ideas\n- Participates in the Amgen Performance Management System (MAP)\n- Help develop product and disease state knowledge in their GP territory partners to ensure high impact calls in their territories.\nBasic Qualifications Minimum requirements:\n\n- Minimum 3 years GP or Hospital sales experience (or combination of)\n- Some experience with computer systems (CRM databases and MS Office)\n- Fluency in English, both in oral and written communication\n- Relevant local qualifications e.g. Medicines Australia Accreditation\n- Valid Driver's licence\n\nApplicants must be located in and have work rights in Australia to be considered for this position\nPreferred Qualifications Preferred Requirements:\n- Science or nursing or business qualifications (Bachelor\u2019s degree)\n- Basic knowledge of and experience in a hospital environment\n- Knowledge of Customer Relation Management principles\n- Exposure to interactions with various disciplines and organizational levels\n- Exposure to project management principles", "date_new": "2012-05-11 18:20:29", "url": "http://www.amgen.jobs/xml/28633379/job", "country": "Australia", "company": "Amgen", "title": "Sr Biopharmaceutical Rep - Qld North (Bone)", "reqid": "15688BR", "state": null, "state_short": null, "location": "Brisbane, AUS", "uid": 28633379}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15692BR\nJob Posting Title Sr Project Manager - IS Application Hosting Services Infrastructure Group\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Senior Project Manager position resides in the Application Hosting Services (AHS) infrastructure group within Amgen and provides an exciting opportunity to work in a leading biotechnology company that uses cutting edge research to discover, develop, manufacture, and deliver innovative human therapeutics. The AHS group is responsible for designing, testing, implementing, and operating the shared infrastructure services for Amgen\u2019s worldwide IS needs across such diverse disciplines as storage, virtualization, private and public clouds, database, datacenter management, operating systems, and data protection. The core responsibility of this position will be to plan, manage, and track major projects that use resources across all the AHS disciplines. In addition, the successful candidate will be working directly with Director and Executive Director leadership in planning effective resourcing directions, cost containment, and efficiency strategies in project management and human resourcing. This position is a senior-level opportunity working in multiple disciplines including the following: program and project management, finance, and technical experience in infrastructure technologies and services.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree or & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Extensive experience in managing a software development and/or infrastructure engineering development lifecycle using both waterfall and agile methodologies and driving, tracking and reporting on multiple projects simultaneously\n\nProven track record tracking complex projects using industry standard project management software such as Microsoft Project\n\nExperience designing, deploying, and maintaining project reporting and tracking system(s) using a self-service web portal where project status can be viewed by interested members of the company\n\nProficient level of scripting, software development, or web service development to deploy and maintain a reporting and tracking portal\n\nDemonstrated financial experience in budgeting, tracking, and reporting financial status to all levels of management\n\nStrong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management.\n\nUnderstanding of, and experience with, ITIL 3.0 best practices and enterprise change control procedures.\n\nExperience working with different forms of project resourcing strategies, such as vendor outsourcing, staff augmentation, SOW creation, FTE hiring, and matching near-term and long-term human resource planning to project load\n\nDemonstrated experience planning complex dependencies into simplified timelines and deliverable schedules, managing rapidly changing priorities, and tracking financial status of many simultaneous projects.\n\nAbility to effectively communicate status, progress, issues, and roadblocks in a timely and effective manner to technical engineers, client representatives, and senior and C-level executives.\n\nExperience rolling up 25-30 simultaneous projects into an on-line reporting and tracking system where project teams, technical leadership, and client teams can visit the portal to find the status of a given project within a two-day reporting window.\n\nA consistent track record of delivering complex technical projects on time and to budget is a must for this role.", "date_new": "2012-05-11 18:18:23", "url": "http://www.amgen.jobs/xml/28633343/job", "country": "United States", "company": "Amgen", "title": "Sr Project Manager - IS Application Hosting Services Infrastructure Group", "reqid": "15692BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28633343}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15191BR\nJob Posting Title Principal Engineer - Primary Container Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful candidate for this position is required to provide hands-on technical leadership to primary container selection and commercialization as it relates to Design for Manufacturability (DFM) . Job responsibilities will be primarily focused on providing expert technical leadership in ensuring that the design of primary containers, and their packaging systems (for aseptic containers) integrate flawlessly with fill finish equipment. This includes expertise in determining critical interfaces of the container design and equipment.\n\n\u2022 Apply expertise in a fundamental scientific principles to analyze the component design and machinery interfaces both in terms of geometric dimensions and tolerances, forces and kinetics.\n\u2022 Evaluate and solve complex technical issues, design, execute and interpret necessary experiments, lead technology transfers, and address complex process deviations.\n\u2022 Communicate and/or present scientific and technical information within area of expertise to a diverse set of audiences, including project teams, and senior management.\n\u2022 Operate in a highly matrixed environment to collaborate effectively with cross functional teams, critically analyze study protocols, reports and risk assessments, communicate and elevate technical or strategic issues to team members and management as needed, and make recommendations and/or decisions to guide successful execution of process transfers.\n\u2022 Apply fundamental scientific (Mechanical Engineering, Material Sciences, statistics, etc.) to identify and ensure scalable component/equipment systems that can be transferred to high speed production.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph.D. in Mechanical Engineering, or Material Science, or related field with 3 + years experience within a regulated industry; experience to include physical characterization of componnets, and experience in developing manufacturing processes from pilot to production scale with an aim for zero preventable defects. .\n\u2022 Experience including optimization of equipment designs, and equipment interactions, statistical design (Six sigma is highly desired), Geometric Dimensions and Tolerances, Kinetic modeling, DOE, and DFM tool sets.\n\u2022 Strong problem solving, trouble shooting, and communication skills are required.\n\u2022 Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment.\n\u2022 Participate as author for process documentation of primary containers, technical reports.\n\u2022 The candidate must have experience in scaling production processes in a regulated environment.", "date_new": "2012-05-11 18:17:19", "url": "http://www.amgen.jobs/xml/28633309/job", "country": "United States", "company": "Amgen", "title": "Principal Engineer - Primary Container Engineering", "reqid": "15191BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28633309}, {"country_short": "USA", "city": null, "description": "Auto req 15620BR\nJob Posting Title Hospital System Mgr - Long Beach/San Diego Academic Orange Territory\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Field Based\nLocation (City) Field Based\nAmgen Job Description Territory #18713 - Long Beach/San Diego Academic Orange; Territory Covered: University of California, Irvine Medical Center, Long Beach VAMC, Scripps-Green Hospital and Clinics, San Diego VAMC, University of California, San Diego Medical Centers, Naval Regional Medical Center\n\nThe Hospital System Manager will act as the primary customer contact for demand creation within targeted hospitals through the execution of marketing strategy techniques and promotion of Amgen products as directed by HS District Managers to achieve or exceed sales objectives. Primary customers include physicians, pharmacists, prescribing physician assistants, nurse practitioners, and executive management; and secondary customers include nurses. Employees may also give additional support to buyers and reimbursement coordinators.\n\nSpecific responsibilities of this position include achieving or exceeding sales targets by executing marketing strategy techniques such as delivering branded sales messages or executing POA through business-to-business selling techniques. This role will also resolve / triage reimbursement issues, maintain and negotiate hospital product contracts\n\nHospital System Managers are also responsible for maintaining and growing executive relationships with key customer base, managing accounts to ensure optimal product formulary access, and influencing positive formulary decisions with key P & T committee members. Additional responsibilities include providing feedback on marketing strategies, developing territory plans with HS District Manager, and implementing approved territory plan and monitor plan executions against targets.\nBasic Qualifications - Master\u2019s degree & 3 years of directly related experience\nOR\n- Bachelor\u2019s degree & 5 years of directly related experience\nPreferred Qualifications Bachelors or advanced degrees preferred (e.g. MBA, MPH, etc.)\n- 5+ years of healthcare sales experience, including teaching hospital or health systems (executive level), and/or P & T selling.\n- Hospital clinic, oncology, nephrology, or rheumatology experience\n- Injectable experience preferred\n- Knowledge of territory and reimbursement/managed care experience ideal.\n- Ability to demonstrate excellent communication skills, mock/detail/presentation skills, and a proven track record selling multiple products in the hospital setting\n- Ability to develop thought leaders/residents & fellows, and maintain and grow executive relationships (e.g., CEO, CFO, CMO) in health systems\n- Ability to analyze and interpret hospital economics/financial performance, successfully navigate through health systems reimbursement, and experience with contract negotiation", "date_new": "2012-05-11 18:16:58", "url": "http://www.amgen.jobs/xml/28633302/job", "country": "United States", "company": "Amgen", "title": "Hospital System Mgr - Long Beach/San Diego Academic Orange Territory", "reqid": "15620BR", "state": null, "state_short": null, "location": "Virtual, USA", "uid": 28633302}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15468BR\nJob Posting Title Clinical Research Medical Director - Oncology - Xgeva\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Clinical Research Medical Director is responsible for:\n\n- Supporting the development, execution and communication of the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Supporting the development of key scientific external relationships with opinion leaders\n- Participating and providing clinical input into safety and regulatory interactions\n\nKey Activities:\n\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Interpret clinical trial data\n- Participate in safety assessments\n- Participate in interactions with regulatory agencies\n- Author CSRs, publications and regulatory submissions\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL\n- Identify new clinical research opportunities\n- Support in-licensing and out-licensing activities and partner relationships\n- Support product lifecycle management for new indications as directed by Global Development Leader\n- Provide clinical content input to:\n- Regulatory interactions and documents\n- Safety interactions and documents\n- Materials to be used in Scientific Affairs\n- Materials to be used by the Commercial Organization\nBasic Qualifications - MD\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\nPreferred Qualifications - MD plus accredited residency in oncology, board certified or equivalent\n- Experience in GU Oncology\n- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\n- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n- prior oncology clinical research / experience\n\nKnowledge\n\n- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Sound scientific and clinical judgment\n- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- Demonstrated ability as a medical expert in a complex matrix environment\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-05-10 18:49:03", "url": "http://www.amgen.jobs/xml/28605679/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Director - Oncology - Xgeva", "reqid": "15468BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28605679}, {"country_short": "GBR", "city": "Cambridge", "description": "Auto req 13698BR\nJob Posting Title Regulatory Affairs Sr Mgr\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Cambridge\nUxbridge\nAmgen Job Description Overview:\n\nThe Regulatory Affairs Senior Manager is responsible for leading regulatory aspects of a product\u2019s development, blending strategic and project delivery; team management and providing subject matter expertise globally.\n\nThe emerging markets team is responsible for development and implementation of regional regulatory strategies to expedite global development and registration. This includes:-\n\u2022 Interfacing with the Amgen Regional Hubs for specific strategies or activities that impact a specific region.\n\u2022 Managing the execution of regional strategies and regulatory communications and submissions.\n\u2022 Providing expertise on regional regulatory requirements and precedence to interdepartmental teams.\n\n\nResponsibilities:\n\u2022 Lead the international regulatory aspects of a product\u2019s development.\n\u2022 Be responsible for the regional strategy and execution of the preparation of MA and life cycle submissions.\n\u2022 Assemble and provide timely regional regulatory input to Global Development Team (GDT) and other cross-functional project meetings consistent with Global Regulatory Team (GRT) strategy.\n\u2022 Ensuring global and regional strategy can be implemented within constraints of local requirements through coordination of LOC expertise.\n\u2022 Assist GDT to develop study protocols reports and development plans aimed at achieving regulatory approval and product labelling that supports key messages.\n\u2022 Develop proactive relationship with these regulatory authorities.\n\u2022 Providing technical and/or managerial support for the creation review and finalisation of components of CTA and/or Marketing Applications as well as routine regulatory submissions\n\u2022 Troubleshoot and resolve any problems on the critical path to regional registration in concert with global registration strategy.\nBasic Qualifications \u2022 Relevant Bachelor\u2019s degree is essential\n\u2022 In depth practical experience of the drug development process, from early phase to approval, as well as post-marketing experience.\n\u2022 Experience of managing a centralised procedure for regulatory submission.\n\u2022 Scientific expertise and acumen to work with colleagues across disciplines leading the regulatory agency submission process\n\u2022 Direct line management experience\n\u2022 Experience of liaising with relevant regulatory authorities for scientific advice.\nPreferred Qualifications \u2022 Experience gained within a biologics organisation\n\u2022 Second degree or further education/qualifications\n\u2022 Project management expertise", "date_new": "2012-05-10 18:48:28", "url": "http://www.amgen.jobs/xml/28605646/job", "country": "United Kingdom", "company": "Amgen", "title": "Regulatory Affairs Sr Mgr", "reqid": "13698BR", "state": null, "state_short": null, "location": "Cambridge, GBR", "uid": 28605646}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15652BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - Cincinnati, OH\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Ohio\nLocation (City) Field Based\nAmgen Job Description Territory#15305, Cincinnati North, which is part of the Indianapolis Blue District; covering - Portsmouth, OH and areas around north Cincinnati, into Indiana, including Richmond, Greensburg, Shelbyville, Connersville and Madison\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-05-10 18:48:24", "url": "http://www.amgen.jobs/xml/28605642/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - Cincinnati, OH", "reqid": "15652BR", "state": "Ohio", "state_short": "OH", "location": "Field Based, OH", "uid": 28605642}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14384BR\nJob Posting Title Clinical Research Senior Medical Scientist - Oncology\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Clinical Research Senior Medical Scientist is responsible for:\n\n- Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Participating and providing clinical input into safety and regulatory interactions\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols)\n- Interpret clinical trial data\n- Participate in safety assessments\n- Review and provide clinical scientific input to TLGs and safety narratives\n- Review scientific literature\n- Initiate database analyses to support commercial/clinical objectives\n- Contribute to the preparation of clinical study reports and regulatory submissions\n- Participate in interactions with regulatory agencies\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL\n- Identify new clinical research opportunities\nBasic Qualifications -MD\nPreferred Qualifications - MD plus accredited residency in oncology, board certified or equivalent\n- Two (2) or more years of clinical research experience and/or basic science research\n\nKnowledge:\n\n- Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Medical knowledge in the relevant therapeutic area\n- Sound scientific and clinical judgment\n- Familiarity with regulatory agency organization, guidelines, and practices\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-05-10 18:47:06", "url": "http://www.amgen.jobs/xml/28605575/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Senior Medical Scientist - Oncology", "reqid": "14384BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28605575}, {"country_short": "USA", "city": "Woburn", "description": "Auto req 15596BR\nJob Posting Title Sr Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Massachusetts\nLocation (City) Woburn\nAmgen Job Description Under general direction provide the coordination and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support manufacturing facilities. In addition the candidate will have to have an understanding of how the various pieces of manufacturing equipment operate, and experience in the field of Validation and Engineering. Self motivated individual who can function with minimal directions.\nKey Responsibilities:\n\u2022 Assist with the administrative and execution of Validation plans and validation protocols for major projects on site (facility, manufacturing processes, equipment, cleaning, and software).\n\u2022 Assist with the validation activities for the expansion project.\n\u2022 Prepare and /or revise validation protocols/procedures as required.\n\u2022 Review and execute qualification and summary reports, write and revise as needed.\n\u2022 Participate in review of manufacturing operational SOPs and maintenance for facility and process.\n\u2022 Assist in troubleshooting, complex or usual problems arising from equipment/system failures.\n\u2022 Ensure continuous validation maintenance for facility and process through change control program.\n\u2022 Analyze validation data, prepare reports, and make recommendations for changes and or/improvements.\n\u2022 Represent department in meetings when required.\n\nOther Responsibilities:\n\u2022 Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.\n\u2022 Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.\n\u2022 Interface with manufacturing, technical operation and QC group.\nBasic Qualifications Doctorate degree\n\nOR\n\nMaster\u2019s degree and 3 years of directly related experience\n\nOR\n\nBachelor\u2019s degree and 5 years of directly related experience\n\nOR\n\nAssociate\u2019s degree and 10 years of directly related experience\n\nOR\n\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications Educational Requirements: Minimum of a BS in Engineering or related technical discipline.\nExperience and Skill Requirements:\n\u2022 6-8+ years experience in the validation of biotechnology or pharmaceutical equipment and processes.\n\u2022 Technical understanding of pharmaceutical/biotechnology unit operations.\n\u2022 Strong communication and interpersonal skills\n\u2022 Good knowledge of cGMP requirements and current industry practices\n\u2022 Demonstrate ability to work in a cross-functional team environment\n\u2022 The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.", "date_new": "2012-05-09 20:34:40", "url": "http://www.amgen.jobs/xml/28581296/job", "country": "United States", "company": "Amgen", "title": "Sr Validation Engineer", "reqid": "15596BR", "state": "Massachusetts", "state_short": "MA", "location": "Woburn, MA", "uid": 28581296}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14257BR\nJob Posting Title Director, Quality Engineering- Drug Delivery\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful Director of Device Quality Engineering will lead and build a dynamic team that supports all new product development across the organization. In this high profile assignment you will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing technology. This team is responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. A key driver of success in this role is to translate design requirements into processes that ensure quality attributes in the design are maintained and are practical for manufacturing. You also will be the Device Quality Project lead on various high profile combination product teams.\nThe candidate will work closely with Device Engineering to facilitate the development of innovative technology in a timely manner. Programs are focused on early development through transition to manufacturing with some sustaining work and will include risk management, reliability and failure analysis, and quality planning. Other responsibilities include independently determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements.  The incumbent should have an understanding of drug product and drug product development requirements.\nKey Responsibilities:\n\u2022 Plans, conducts and executes design control activities requiring judgment in the independent evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria.\n\u2022 Ensure team works closely with product development engineering and the supplier/contractor team to establish the system design specifications and product requirements.\n\u2022 Ensure team works closely with design, development, quality, regulatory, and the supplier/contractor team to establish and document the master verification and validation plans in conformance with the system design specification and sound testing principles.\n\u2022 Assists in the planning, coordinating and execution of design verification and validation testing to directly support the master verification and validation plans, including any additional activities such as HALT/HASS and IEC 60601-1-x testing, HFE studies, clinical trials and other standardized test methods.\n\u2022 Participates with the engineering team to establish and drive the design FMEA, FMECA and other risk related activities (ISO14971).\n\u2022 Facilitate the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device quality improvements, customer satisfaction, supplier and component initiatives, and safety.\n\u2022 Product reliability design improvements by ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction. Validated product changes with completed documentation that meets or exceeds established guidelines, plus well-documented research/analyses that support decisions and conclusions.\n\u2022 Validation of supplier processes and support of supplier/contractor Quality Agreements.\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nAND\n\u2022 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Advanced degree in an Engineering discipline, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments.\n\u2022 4 years of Quality managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources and have lead the commercial launch of a medical device.\n\u2022 CQA, CQM, Six Sigma Black Belt preferred.\n\u2022 ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485).\n\u2022 Lean and or Six Sigma Certification.\n\u2022 Previous experience in Quality engineering and commercialization process with drug delivery devices and combination drug/device products is desired\n\u2022 Design assurance experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal).\n\u2022 Familiar with PCB/PCA assembly and fabrication.\n\u2022 Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools\n\u2022 Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected.\n\u2022 Experience with complex, cross-functional development projects.\n\u2022 Experience working with and leading cross-cultural teams.\n\u2022 Proven ability to apply situational leadership concepts across various intra and inter-departmental matters.\n\u2022 Demonstrated time management, decision making, presentation and organization skills.\n\u2022 Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.", "date_new": "2012-05-09 20:34:27", "url": "http://www.amgen.jobs/xml/28581281/job", "country": "United States", "company": "Amgen", "title": "Director, Quality Engineering- Drug Delivery", "reqid": "14257BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28581281}, {"country_short": "CHE", "city": "Zug", "description": "Auto req 15674BR\nJob Posting Title Senior Associate Clinical Operations Management\nCareer Category Clinical\nEmployee Subgroup Invoice Paid FT\nCountry (State/Region) Switzerland\nLocation (City) Zug\nAmgen Job Description The Sr. Associate, Clinical Operations Management will support Clinical Operations Managers with overseeing operational activities related to planning, executing, and reporting of Phase 3 and 4 Amgen sponsored clinical trials. Main responsibilies include:\n\nContribute to the design and preparation of the draft informed consent template, ensuring Local content is added\nAssist in the conduct of feasibility assessments for new clinical protocols if required\nContribute to the identification and selection of clinical investigators\nWork with the Clinical Operations Managers (COM\u2019s) and Senior Associate Clinical Operations Management (SACOMs) colleagues to formulate a comprehensive recruitment plan for each new project.\nContribute to the development of study specific processes including study communication plans\nParticipate in identifying study related issues, and work with the COM and MCFO to initiate corrective actions when necessary\nWith the study-specific COM, plan and conduct monthly project review meetings in order to update all Managers on study progress, issues and planned resolutions.\nParticipate in local team meetings, task forces and liaise with Global Study Team if required\nIdentifying and reviewing process issues within the clinical development group and recommending improvements when required\nAccompany CRA in site evaluations, initiations, monitoring and close out if required.\nAct as back up to COMs when required\nCoordinate & actively participate at local investigators meetings\nReview CQA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues\nPartners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs)\nFor studies with sole project management responsibility (eg Phase 4, follow up and extension studies)\nBasic Qualifications BA/BS/BSc or qualified nurse (RN)\nWork experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)\nPreferred Qualifications Project management experience in life sciences or medically related field obtained working on clinical trials in a biotech, pharmaceutical or CRO company\nOperational performance measurement experience\nInternational collaboration experience", "date_new": "2012-05-09 20:33:38", "url": "http://www.amgen.jobs/xml/28581226/job", "country": "Switzerland", "company": "Amgen", "title": "Senior Associate Clinical Operations Management", "reqid": "15674BR", "state": null, "state_short": null, "location": "Zug, CHE", "uid": 28581226}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15650BR\nJob Posting Title Sr Mgr Biostatistics\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Senior Manager Biostatistics will implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis\n\u2022Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications\n\u2022Complete statistical analysis of multiple studies/projects\n\u2022Hire, manage and develop statistical staff\n\u2022Contribute to resource and budget planning\n\u2022Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)\n\u2022Be familiar with statistical policy and strategy at Amgen\n\u2022Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field\n\u2022Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen\n\u2022Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents\n\u2022Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings\n\u2022May lead and/or participate in change / process improvement initiatives\n\u2022May participate in external activities (e.g. Industry, academic)\nBasic Qualifications .Doctorate degree & 2 years of directly related experience\nOR\n.Master\u2019s degree & 6 years of directly related experience\nOR\n.Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nAND\n. 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry,\nwith Bachelor\u2019s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer\nScience, Mathematics, Life Sciences, or other relavent scientific subject\nStrong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines\nStrong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues\nDisplays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes\nTrack record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results\nTakes steps to ensure the ongoing technical development", "date_new": "2012-05-08 18:44:22", "url": "http://www.amgen.jobs/xml/28541377/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Biostatistics", "reqid": "15650BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28541377}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15592BR\nJob Posting Title Business Performance Mgr (Finance)\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Business Performance Mgr will be Finance and G&A focused but will also support other functional areas as well. The Manager of Business Performance will respond to project requests from executives and supervise / execute work with high quality results. In doing so s/he will structure the issues and analyses, manage the work, and prepare and present findings. This role will also support business functions by identifying opportunities and risks and developing the strategies to address them. The Manager of Business Performance will be responsible for developing approaches to improve productivity and implement comprehensive change strategies to transform an organization and enable it to adapt to business challenges. This role will interact with a wide range of leadership and staff inside and outside of Amgen (consultants).\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Doctorate or Masters in finance, business, science, and/or technology\n\u2022 3+ years experience in finance, biotechnology /pharmaceutical, top tier Management Consulting and / or Investment Banking firms\n\u2022 Experience at a top tier Management Consulting Firm\n\u2022 Strong presence with Senior Executives including ability to communicate effectively on a prepared and ad-hoc basis\n\u2022  Experience in financial modeling and budgeting\n\u2022 Strong quantitative and qualitative analytic skills, specifically financial analysis with an emphasis on valuation\n\u2022  Certification in lean and / or Six Sigma\n\u2022 Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution\n\u2022 Strong leadership skills with a demonstrated ability to influence different styles\n\u2022 Proven experience as a member of a high performing team", "date_new": "2012-05-08 18:43:57", "url": "http://www.amgen.jobs/xml/28541363/job", "country": "United States", "company": "Amgen", "title": "Business Performance Mgr (Finance)", "reqid": "15592BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28541363}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15647BR\nJob Posting Title Scientist (Cell Sciences & Technology)\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position is for an entry level scientist that will be involved in cell culture process development in support of pipeline molecules. The successful candidate will play a key role in leading and supporting various project teams.\n\nAside from process optimization, the work will frequently involve scale-up of bioreactors and transfer of processes to pilot plant and cGMP manufacturing facilities. The individual will also be responsible for advancing process technology and proprietary cell culture medium in order to improve productivity and efficiency, and control desirable product quality. The person will also be expected to play a technical leadership role in the department for various technology development initiatives in the organization.\n\nNeeds to be very hands-on with all scales of cell culture operation from plate to shake flask to bioreactors. Will often conduct independent research studies and be expected as a self-starter of research projects. Must consistently keep up-to-date of scientific publications in order to incorporate new scientific understanding and technology into development work. This person will also author technical reports and publications on a routine basis.\nBasic Qualifications - Doctorate degree\nOR\n- Master\u2019s degree & 6 years of scientific  experience\nOR\n- Bachelor\u2019s degree & 8 years of scientific experience\nPreferred Qualifications - Ph.D. in chemical engineering, biochemical engineering, bioengineering or biochemistry; some experience post Ph.D. in a postdoctoral research or industrial setting is desirable\n- Must be familiar with mammalian cell culture in the context of process development such as host cell engineering, transfection, stable cell line generation, clone selection, medium development, bioreactor design, optimizing productivity, and characterization using different modes of reactor operation\n- Knowledge of cellular metabolism and glycosylation, molecular cloning techniques, assay development for understanding cellular mechanisms, and high-throughput cell culture technology are strongly desired\n- Ability to use various statistical methods to analyze and interpret data is critical.\n- Need to have strong project management and organizational skills", "date_new": "2012-05-08 18:42:31", "url": "http://www.amgen.jobs/xml/28541276/job", "country": "United States", "company": "Amgen", "title": "Scientist (Cell Sciences & Technology)", "reqid": "15647BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28541276}, {"country_short": "USA", "city": null, "description": "Auto req 15490BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - Miami, FL\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Field Based\nLocation (City) Field Based\nAmgen Job Description Sr Biopharmaceutical Rep, Oncology - Miami, FL\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-05-08 18:40:38", "url": "http://www.amgen.jobs/xml/28541245/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - Miami, FL", "reqid": "15490BR", "state": null, "state_short": null, "location": "Virtual, USA", "uid": 28541245}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15524BR\nJob Posting Title Engineering Projects Sr Mgr (IS Project Controls)\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The IS Project Controls Senior Manager will be responsible to handle a broad range of projects executed at multiple locations around the world.  The scope of responsibilities span from liaison with corporate management to obtaining project funding, through managing and objectively reporting project status to senior management. Projects typically range in value from a few hundred thousand  dollars to multi million dollars. Project complexity ranges from simple hardware replacement to complete business system replacements. The successful candidate will be the IS project control\u2019s Lead, and will interface with all levels of management across functional areas. The individual in this position will report directly to the Executive Director Engineering Project Controls and via dotted line to the Director Information Systems Business Services.\n\nThe IS Project Controls Senior Manager will be responsible for developing, with the project team, project funding documents, assisting in budget, schedule and change management, cost and schedule risk analysis, cash flow analysis, and developing historical cost data for bench marking purposes. In addition, he/she will review and analyze contractor cost estimates, bids, change orders, invoices, labor rates, physical engineering/construction progress, etc. The IS Project Controls Senior Manager will be responsible for budgeting, tracking and controlling Amgen costs as well as Construction, IS and Automation engineer, vendors and contractor costs.\n\nThe IS Project Controls Senior Manager will also be responsible for sourcing, onboarding, training, and overseeing all of the contingent workers who are assigned to IS projects. In addition, he/she will also lead the standardization of all project control processes to be used in IS.\n\nFunctions (Duties/Accountabilities):\n1. Assist the Project Manager(s) in developing project strategies\n2. Assist in the preparation of Amgen project funding documents\n3. Assist in developing strategies and negotiating pricing for scope of work for subcontractors and vendors such as G-Max, unit pricing, time and material, etc.\n4. . Reviewing and analyzing Construction, IS and Automation engineers, vendors and contractor bids\n5. Evaluate Construction, IS and Automation engineers, vendors and contractors physical progress\n6. Develop and monitor project schedules and cash flow\n7. Develop Construction, IS and Automation engineering, vendors and construction cost forecasts for remaining work\n8. Reviewing, approving Construction, IS and Automation engineers, vendors and contractor buy outs, change orders and invoices\n9. Administrating the closeout of contracts and purchase orders.\n10.Prepare monthly project status reports for senior management\n11 Lead risk analysis reviews for cost estimates, cost forecasts and schedules using applicable software packages.\n12. Project controls resource planning for IS\n13. Development of common project control standards to be used in IS\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Bachelors Degree in Engineering, Technology or Life Sciences\n\u2022 8 + years of experience in commercial and/or industrial construction in project controls: i.e. cost control, scheduling and estimating\n\u2022 5 + years in biotechnology/pharmaceutical industries\n\u2022 Experience in IS systems supporting global/multiple sites\n\n\u2022 Proficiency in using SAP, CPM Scheduling and @ Risk software\n\u2022 Proven ability to manage and deliver results in a highly fluid, interactive matrix environment\n\u2022 Commercial and/or industrial construction experience could include: strong technical knowledge in construction cost and schedule management. In addition, have strong analytical skills for estimate analysis, bid evaluations, budget monitoring, cash flow analysis, risk analysis and benchmarking project costs. The individual must have a good understanding of all types of estimating from conceptual through definitive construction estimates\n\u2022 Lean Construction, Six Sigma certifications and/or other continuous improvement methods", "date_new": "2012-05-08 18:40:38", "url": "http://www.amgen.jobs/xml/28541246/job", "country": "United States", "company": "Amgen", "title": "Engineering Projects Sr Mgr (IS Project Controls)", "reqid": "15524BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28541246}, {"country_short": "AUS", "city": "Sydney", "description": "Auto req 15613BR\nJob Posting Title Associate Congress & Events\nCareer Category Sales & Marketing Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) Australia\nLocation (City) Sydney\nAmgen Job Description 11 month full time contract role, based in Sydney, Australia.\nReporting to: Senior Associate Congress & Events\n\nAccountabilities:\n- Ensure coordination and organisation of Amgen\u2019s participation (as sponsor, co-sponsor or guest) at third party international congresses and events\n- Facilitate and oversee full event management services for Amgen owned educational events and staff internal meetings\n- Ensures an optimal liaison between the different parties (Business Unit stakeholders, external agencies & suppliers)\n\nResponsibilities:\n- Supports the Business Unit (BU) Project Lead in organising participation (i.e sponsorship) at 3rd Party Events, including sponsorship of Healthcare Professionals\n- Supports the BU Project Lead with end-to-end event management services for Amgen owned educational events\n- Ensure high quality services in planning and onsite at all congress & events\n- Complies with and educates others on company policy & procedures as per formal BPPs\n- Updates, maintains all relevant event, delegate & budget data in StarCite\n- Communicates with internal stakeholders & agency partners to disseminate all information relevant to Congress & Events, providing clear guidance on service requirements aligned with Amgen policies & procedures\n- Monitors and meets deadlines (e.g. invoices, purchase orders, promotional materials, payments to Healthcare Professionals, etc)\n- Organises and attends site inspections, where appropriate\n- Facilitate and/or coordinate supplier agreements(e.g., venues, restaurants, exhibition hire, agencies etc)\n- Organises and follows-up on tenders in order to select the appropriate agency\n- Liaise with European Congress Team to provide updates on Australian affiliate attendance at Congresses\n- Manages each event within agreed budget\nBasic Qualifications Minimum requirements:\n- High School Certificate\n- Minimum 2 \u2013 3 years of related meetings & event industry experience\n- Knowledge and experience with Medicine\u2019s Australia Code of Conduct\n- Knowledge of travel and tourism industry\n- Fluency in English, both verbally and written\n- Experience with MS Office programs\n\n\nApplicants must be based in Australia, with relevant work rights, to be considered for this position.\nPreferred Qualifications Preferred qualifications:\n\n- Degree in Business or Marketing\n- Basic knowledge of Marketing and Finance procedures\n- Experience in the pharmaceutical industry\n- Experience in Hotel administration or Hospitality industry\n- Experience with StarCite", "date_new": "2012-05-07 18:07:34", "url": "http://www.amgen.jobs/xml/28478117/job", "country": "Australia", "company": "Amgen", "title": "Associate Congress & Events", "reqid": "15613BR", "state": null, "state_short": null, "location": "Sydney, AUS", "uid": 28478117}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15646BR\nJob Posting Title Hospital System Mgr - Columbus, OH Academic Blue\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Ohio\nLocation (City) Field Based\nAmgen Job Description Territory #15702 Columbus, OH covering Columbus, OH\n\nThe Hospital System Manager will act as the primary customer contact for demand creation within targeted hospitals through the execution of marketing strategy techniques and promotion of Amgen products as directed by HS District Managers to achieve or exceed sales objectives. Primary customers include physicians, pharmacists, prescribing physician assistants, nurse practitioners, and executive management; and secondary customers include nurses. Employees may also give additional support to buyers and reimbursement coordinators.\n\nSpecific responsibilities of this position include achieving or exceeding sales targets by executing marketing strategy techniques such as delivering branded sales messages or executing POA through business-to-business selling techniques. This role will also resolve / triage reimbursement issues, maintain and negotiate hospital product contracts\n\nHospital System Managers are also responsible for maintaining and growing executive relationships with key customer base, managing accounts to ensure optimal product formulary access, and influencing positive formulary decisions with key P & T committee members. Additional responsibilities include providing feedback on marketing strategies, developing territory plans with HS District Manager, and implementing approved territory plan and monitor plan executions against targets.\nBasic Qualifications - Master\u2019s degree & 3 years of directly related experience\nOR\n- Bachelor\u2019s degree & 5 years of directly related experience\nPreferred Qualifications Bachelors or advanced degrees preferred (e.g. MBA, MPH, etc.)\n- 5+ years of healthcare sales experience, including teaching hospital or health systems (executive level), and/or P & T selling.\n- Hospital clinic, oncology, nephrology, or rheumatology experience\n- Injectable experience preferred\n- Knowledge of territory and reimbursement/managed care experience ideal.\n- Ability to demonstrate excellent communication skills, mock/detail/presentation skills, and a proven track record selling multiple products in the hospital setting\n- Ability to develop thought leaders/residents & fellows, and maintain and grow executive relationships (e.g., CEO, CFO, CMO) in health systems\n- Ability to analyze and interpret hospital economics/financial performance, successfully navigate through health systems reimbursement, and experience with contract negotiation", "date_new": "2012-05-07 18:07:30", "url": "http://www.amgen.jobs/xml/28478116/job", "country": "United States", "company": "Amgen", "title": "Hospital System Mgr - Columbus, OH Academic Blue", "reqid": "15646BR", "state": "Ohio", "state_short": "OH", "location": "Field Based, OH", "uid": 28478116}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15649BR\nJob Posting Title Clinical Research Medical Dir\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Research Medical Director (Biosimilars) is responsible for:\n\u2022 Supporting the development, execution and communication of the global clinical plan\n\u2022 Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n\u2022 Participating and providing clinical input into safety and regulatory interactions\n\u2022 Supporting the development of key scientific external relationships with opinion leaders\n\nKey Activities\n\u2022 Provide clinical/scientific input during the development and execution of clinical trials\n\u2022 Interpret clinical trial data\n\u2022 Participate in safety assessments\n\u2022 Participate in interactions with regulatory agencies\n\u2022 Author regulatory submissions and publications\n\u2022 Develop key opinion leaders and make scientific presentations\n\u2022 Support in-licensing and partner relationships\n\u2022 Support product lifecycle management\nBasic Qualifications \u2022 MD with clinical experience in Oncology\n\u2022 Three (3) or more years of clinical research experience in biotechnology/pharmaceutical industry or CRO company\nPreferred Qualifications \u2022 MD plus accredited residency in Oncology, board certified or equivalent\n\u2022 Five (5) or more years of clinical research experience in biotech/pharma/CRO company and basic science research combined with clinical teaching or patient care activities\n\u2022 Experience in all phases of clinical research (Phase 1-4)\n\u2022 Experience interacting with FDA and international regulatory agencies\n\u2022 In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n\u2022 Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n\u2022 Sound scientific and clinical judgment\n\u2022 Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements\n\u2022 Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n\u2022 Demonstrated ability as a medical expert in a complex matrix environment\n\u2022 History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-05-07 18:07:01", "url": "http://www.amgen.jobs/xml/28478115/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Dir", "reqid": "15649BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28478115}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 15553BR\nJob Posting Title Specialist IS Analyst - Data Center Infrastructure Lead\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nUnited States - Washington\nLocation (City) Seattle\nThousand Oaks\nAmgen Job Description The Data Center Operations Lead position resides in the Application Hosting Services (AHS) group within Amgen.\n\nThis role can be based at either Amgen's Thousand Oaks, California headquarters or at Amgen's site in Seattle, Washington.\n\nThis position is both a strategic-leadership position as well as an operational excellence position in providing direction in Amgen\u2019s future data center strategy as well as supporting and improving our current global data center footprint. This position requires a qualified candidate to be up-to-date in all data center best practices, technologies, and environmental directions. The primary responsibilities of this position will be to support and drive Amgen\u2019s future data center center directions, provide leadership in financial and technical analysis for both strategic and operational directions, manage daily operations and lead datacenter team, support SOX and GxP audits, and provide data center best practices for Amgen\u2019s worldwide data center infrastructure.\n\nThe following highlights some of the functions of this position:\n\n\u2022 Leading data center designs for any new builds, upgrades or retrofits, migrations, and interfacing with facilities or other data center experts as needed.\n\u2022 Lead the development of Standard Operating Procedures (SOPs), Manuals (MANs), Standards (STNDs) and other documented processes for data center processes.\n\u2022 Reviewing, enhancing, and improving the monitoring of power, cooling, space and other capacity metrics and managing appropriate capacity reports.\n\u2022 Support, coordination, planning and/or oversight of data center shutdown and startup efforts and other data center related maintenance activities.\n\u2022 Maintain data center drawings using CAD tools, and manage / track all physical assets in the data center management tool.\n\u2022 Assist with and/or provide direct support of SOX reporting in regards to data center access, including the collection and organization of associated supporting objective evidence.\n\u2022 Plan for and provide 24x7 on-call datacenter access to support production system issues.\n\u2022 Work with IS staff across the functional areas to facilitate process and tool changes, align execution standards, and communicate changes.\n\u2022 Analyze and report on incident trends, process adherence, service performance and metrics.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor\u2019s degree plus five or more years of data center infrastructure experience.\n\nExtensive data center domain knowledge and/or five (5) or more years experience in supporting and/or managing Data Center Facilities in a corporate enterprise environment.\n\nOne or more vendor certifications and/or training and competencies (AutoCAD, AFCOM, ACM, ITIL) and/or one or more vendor certifications or training (Uptime Institute, IDCP).\n\nStrong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management.\n\nDemonstrated experience leading project planning, deployment, and lifecycle management for datacenter projects and managing competing priorities and time constraints to meet business objectives.\n\nThe ability to perform financial analysis and manage appropriate budgetary items.\n\nUnderstanding of, and experience with, ITIL 3.0 best practices and enterprise change control procedures.\n\nExperience running facilities in a highly regulated environment.\n\nHigh skill level of standard tools\u2014Microsoft Excel, Word, and PowerPoint.", "date_new": "2012-05-07 18:06:51", "url": "http://www.amgen.jobs/xml/28478114/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Analyst - Data Center Infrastructure Lead", "reqid": "15553BR", "state": "California", "state_short": "CA", "location": "Seattle, CA", "uid": 28478114}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15608BR\nJob Posting Title Sr Biopharmaceutical Rep, Bone Health - Cleveland, TN\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Tennessee\nLocation (City) Field Based\nAmgen Job Description Territory \u2013#53214, Cleveland, TN\ncovering; Cleveland, W Knoxville, Oak Ridge\n\nAmgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\n\nAs a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.\n\nAs a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager\nBasic Qualifications Bachelor\u2019s degree & 2 years of directly related experience\nOR\n- Associate\u2019s degree & 6 years of directly related experience\nOR\n- High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications 2+ years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries\n- Previous experience selling in the osteoporosis market.\n- Expert local knowledge in the primary care or specialty market.\n- Successful launch experience in a highly competitive market.\n- Outstanding business acumen including experience with:\n- Medicare Part B\n- Contracting\n- Managed Care or pull-through\n- Capital equipment or durable medical device sales\n- Proven strategic account management\n\nCore Competencies:\n- Planning and Organizing Work\n- Engaging Others Through Effective Communication\n- Drive to Achieve", "date_new": "2012-05-07 18:05:32", "url": "http://www.amgen.jobs/xml/28478107/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Bone Health - Cleveland, TN", "reqid": "15608BR", "state": "Tennessee", "state_short": "TN", "location": "Field Based, TN", "uid": 28478107}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15618BR\nJob Posting Title Epidemiology Sr Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Observational research (OR) makes important contributions to drug development and commercialization along with randomized clinical trials. OR contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, cost and utilization patterns, and the safety and effectiveness of interventions. In the current environment, there is increasing demand for information from OR studies by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) has been created to address this imperative.\n\nJob Summary\n\nThe OR Sr. Manager is a major contributor within one of the CfOR Therapeutic Areas (Oncology, Bone, Cardio/Renal, General Medicine & Inflammation) and reports directly to a Product Lead.\n\nThis position will be located at Amgen's Thousand Oaks headquarters.\n\nAn OR Sr. Manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer reviewed journals or for internal reports that enhance the company\u2019s mission.\n\nKey Activities Include\n\u2022 Contributes to research strategy within the product team and observational research TA\n\u2022 Responsible for conducting high-quality observational research to support product strategy within TA\n\u2022 Executes safety-related analyses/studies\n\u2022 Provides support for safety surveillance across the life cycle of Amgen products\n\u2022 Support preparation of PSRM materials\n\u2022 Executes process of patient exposure estimation for marketed products\n\u2022 Supports development of risk management plans\n\u2022 Plans and conducts database analyses to answer key questions with the product teams\n\u2022 Collaborates with Health Economics colleagues to generate evidence to support the value plan\n\u2022 Participates in cross-functional teams to develop the research strategy for products and conducts the observational research\n\n\u2022 Supports relationships with key leaders in observational research\n\u2022 Sets annual product-specific and personal goals\n\u2022 Provides input into observational research department meetings\n\u2022 Stays abreast of the latest developments in the field of observational research and drug development and contributes to the field\n\u2022 Promotes observational research awareness\n\u2022 Promotes understanding and use of state of the art observational research methods\n\u2022 Communicates significant scientific information to a variety of audiences\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Preferred Qualifications \u2022 PhD degree in Epidemiology or Medical degree with observational research experience\n\u2022 6 or more years experience in observational research\n\u2022 Record of publications in peer-reviewed journals\n\u2022 3 years experience with Medical or Doctoral degree\n\u2022 Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting\n\u2022 Experience in research to support drug development\n\u2022 Experience in observational research project planning and management\n\u2022 Experience communicating observational research information (written and oral)\n\u2022 Experience working in multi-disciplinary teams\n\u2022 Managerial experience\n\nKnowledgeable in\n\u2022 Basic observational research study designs and analysis\n\u2022 Programming in SAS or other software (e.g. STATA)\n\u2022 Literature search methods\n\u2022 Observational research methodology and applications within Drug Development\n\u2022 Drug development process and operations\n\u2022 Observational research databases\n\u2022 Knowledge of adverse drug experience data", "date_new": "2012-05-07 18:05:15", "url": "http://www.amgen.jobs/xml/28478106/job", "country": "United States", "company": "Amgen", "title": "Epidemiology Sr Mgr", "reqid": "15618BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28478106}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15619BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - Portland, OR\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Oregon\nLocation (City) Field Based\nAmgen Job Description Territory (#18104) Portland, OR; Covering - Portland, Salem, Longview, OR\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-05-06 18:16:30", "url": "http://www.amgen.jobs/xml/28470538/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - Portland, OR", "reqid": "15619BR", "state": "Oregon", "state_short": "OR", "location": "Field Based, OR", "uid": 28470538}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 15522BR\nJob Posting Title Research Operations Sr Mgr\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nUnited States - Washington\nLocation (City) Seattle\nThousand Oaks\nAmgen Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science\u2019s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people\u2019s lives.\n\nThe Research Operations Sr. Manager position involves project, portfolio and budget management responsibilities in addition to providing Chief of Staff support to the Therapeutic Area (TA) head and Senior Management team.\n\nThe Research Operations Sr. Manager will be required to provide portfolio management support to the Research TA by tracking go/no-go decision points for all department projects and working with Sr. Management to outline department strategy and ensure implementation across teams. This employee will participate in departmental alignment meetings with executive staff and is responsible for recording and distributing strategies to internal business partners. This includes responsibility for departmental tracking of FTE (full-time equivalent) allocation and internal portfolio prioritization exercises for resource allocation purposes. The Research Operations Sr. Manager will ensure seamless communication flow between diverse groups, assist with issue resolution and escalation, and ensure timely information transfer between sites and functional areas.\n\nThe Research Operations Sr. Manager is also responsible for department logistics including the planning and execution of department Capital, Collaborator and Travel Budgets; ensuring department compliance of company-wide initiatives and organization of department retreats, poster sessions and all-staff meetings. This position will also serve as the Chief of Staff to the TA Head and will execute projects as requested.\n\nThis employee may be required to provide project management support to early stage cross-functional cross-site research project teams. Duties will include assisting with team formation, creation of team strategy and goals, monitoring project status, documenting team meetings through agendas and minutes, and providing follow up to action items generated at either process team meetings or other relevant meetings. The Research Operations Sr. Manager will ensure seamless communication flow between diverse groups, assist with issue resolution and escalation, and ensure timely information transfer between sites and functional areas.\n\nThe Inflammation TA is a cross-site organization, so travel to alternate sites will be required.\n\nThis role can be filled in either Thousand Oaks, Ca or Seattle, WA.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications The ideal candidate will have minimum of a BS with 8 plus years of related experience in the biotechnology field. An advanced degree is helpful.\n\nThe ability to be proactive and independently understand, follow and implement complex instructions is crucial.\n\nStrong organizational and proven project management skills are extremely desirable.\n\nThis employee should be able to manage multiple tasks at one time and to work effectively with teams using strong interpersonal skills. Working in a collaborative and cross-functional environment will make excellent verbal and written communication expertise essential.\n\nStrong attention to detail, including the ability to proofread and reformat documents will be vital. Evidence of computer literacy required, specifically advanced word processing, spreadsheet and/or database application, and Power Point.", "date_new": "2012-05-06 18:16:10", "url": "http://www.amgen.jobs/xml/28470523/job", "country": "United States", "company": "Amgen", "title": "Research Operations Sr Mgr", "reqid": "15522BR", "state": "California", "state_short": "CA", "location": "Seattle, CA", "uid": 28470523}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15528BR\nJob Posting Title Principal Scientist - Cardiovascular Discovery Research\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science\u2019s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people\u2019s lives.\n\nA new position is available in the Department of Metabolic Disorders at Amgen. The Amgen cardiovascular research group in Metabolic Disorders is looking for a highly motivated principal scientist with experience in biopharmaceutical discovery research and/or academic basic research to join them in their R&D facility in Thousand Oaks, CA.\n\nThe successful candidate will have the primary responsibility of leading a large animal cardiovascular physiology laboratory, focusing on models of heart failure and arrhythmias. This individual must have strong technical skills in such models, and the candidate\u2019s primary responsibility will be hands on implementation and critical interpretation of experiments required to assess compound efficacy using state of the art techniques and methods. The successful candidate must also possess the communication/managerial skills along with the level of expertise such needed to teach relevant techniques to less experienced colleagues and reports.\n\nThe successful candidate will need to work effectively in a fast-paced environment, have the ability to multi-task and work effectively with multiple groups (internal and external to Amgen), have strong oral and written communication skills, and be self-motivated. This position will report directly to the Executive Director of the Cardiovascular Discovery Research Group at Amgen.\nBasic Qualifications Doctorate degree & 5 years of scientific experience\nOR\nMaster\u2019s degree & 12 years of scientific experience\nOR\nBachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications The ideal candidate will have an MD or PhD in a scientific discipline, e.g,. physiology or pharmacology. A minimum of 5 to 10 years or more industrial experience in cardiovascular physiology using models of disease to interrogate the efficacy of therapeutic agents. Hands-on experience with canine models of heart failure and arrhythmias in support of early and late stage preclinical drug discovery projects is highly desirable.\nThe ideal candidate will specifically have hands-on experience with cardiovascular imaging techniques (e.g. echocardiography) and invasive assessment of cardiovascular hemodynamics in large animals. The ideal candidate will also have excellent communication and teaching skills required to head a small group of scientists working interactively within a highly matrixed research environment.", "date_new": "2012-05-04 19:32:51", "url": "http://www.amgen.jobs/xml/28441231/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - Cardiovascular Discovery Research", "reqid": "15528BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28441231}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15520BR\nJob Posting Title Regulatory Affairs Director (Policy, Biosimilars)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description GRAAS Biosimilar Policy is accountable for defining Amgen positions on the scientific, medical and regulatory aspects of biosimilars and advocating those standards to external policy makers while concurrently providing key internal subject-matter expertise to cross-functional executive leadership and teams.\n\nJob Summary:\n- Develop, direct and deliver strategic regulatory plans that are in-line with regulatory and business needs\n- Develop innovative solutions to complex problems through in-depth analysis, coordination and negotiation with subject-matter experts and key decision makers\n- Work in partnership with cross-functional teams and Amgen leadership to develop regulatory plans that support the direction of the business\n- Influence a broad spectrum of internal and external stakeholders toward achieving regulatory and business goals\n- Develop mutually beneficial strategic alliances with internal and external subject matter experts and external key decision makers\n- Engage in direct advocacy with national, regional and global policy makers and regulators\n- Represent Amgen and the innovator industry in policy testimony and on trade association key issue teams\n\nThis position could be located in Thousand Oaks California, or Washington D.C.\nBasic Qualifications - Doctorate degree and 4 years of directly related experience\nOR\n- Master's degree and 8 years of directly related experience\nOR\n- Bachelor's degree and 10 years of directly related experience\nPreferred Qualifications Knowledge and Skills\n- Science background\n- Experience in regulatory or clinical development, ideally with biologics\n- Understanding of national a d global healthcare system, including payers\n- Critical thinker, able to analyze and critique data\n- Intellectually creative, able to assess a situation from multiple perspectives\n- Skilled and credible advocate with experience in 1:1 engagement, large audiences, panel debates\n- Able to form and defend a position under challenge", "date_new": "2012-05-04 19:32:33", "url": "http://www.amgen.jobs/xml/28441221/job", "country": "United States", "company": "Amgen", "title": "Regulatory Affairs Director (Policy, Biosimilars)", "reqid": "15520BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28441221}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15571BR\nJob Posting Title Regulatory Affairs Director (CMC Lead)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Biosimilars are an important new development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients.\n\nQuality biosimilar developments requires integrating all of the analytical science and quality manufacturing experience at Amgen to creatively and rapidly demonstrate comparability to originator products. To facilitate the process and efficient global registrations of the Amgen biosimilar portfolio, the Director for CMC Regulatory Affairs, Biosimilars, will lead the development and execution of regulatory CMC and analytical similarity strategies.\n\nJob Summary:\n- Facilitate product development and global registration of the Amgen biosimilar portfolio by developing and executing regulatory CMC and analytical similarity strategies\n- Facilitate effective global regulatory agency interactions for product manufacturing and quality programs\n- Define and execute long-term global CMC regulatory plans for licensed biosimilar products\n\nResponsibilities include:\nRegulatory Strategy and Filing\n- Provide expertise and leadership in the development, communication, and implementation of global CMC and analytical similarity regulatory strategies in support of biosimilar goals and product portfolio execution\n- Lead cross-functional teams in development and submission of CMC, quality, and analytical similarity regulatory documents\n- Accountable for generation and submission of CMC and quality regulatory documents, including CTAs, MAs, and RTQs, are developed with high quality, delivered in a timely manner, consistent with the overall biosimilar strategies, and compliant with current regulatory authority requirements\n- Ensure product licenses are maintained per regulatory requirements and consistent with biosimilar strategy and long-term planning\n- Support development and execution of clinical/ non-clinical strategies\nRegulatory Interactions\n- Plan, execute and lead agency CMC meetings per regulatory strategy\n- Facilitate ad hoc CMC-related interactions, RTQ responses and meetings\n- Represent the Biosimilars Operating Unit in the coordination and conduct of prior-approval and GMP inspections by regulatory authorities\nRegulatory CMC\n- Design, plan and execute regulatory CMC strategies\n- Scientific oversight of development and delivery of analytical similarity regulatory packages that meet biosimilar regulatory requirements\n- Delivery of CMC information in regulatory documents (including CTAs, MAs, analytical similarity assessments, requests for information, CMC related agency interactions)\n- Represent RA CMC on appropriate teams\n- Manage priorities and resources for multiple products\nRegulatory Intelligence\n- Monitor, assess and implement regional regulatory requirements\n- Assess impact of regulatory decisions for competitive products\n- Generate and communicate biosimilar intelligence to the Biosimilars Operating Unit and Amgen innovative teams as appropriate\nBiosimilars Policy\n- Provide subject matter expertise to GRAAS Biosimilar Policy function\nCollaboration\n- Support vendor oversight and management for regulatory CMC operations\n- Exchange biosimilar CMC and analytical similarity regulatory requirements with regulatory colleagues on an ongoing basis\nBasic Qualifications - Doctorate degree & 4 years of directly related experience\nOR\n- Master\u2019s degree & 8 years of directly related years\nOR\n- Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications -4+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\n- Experience in the biosimilars/ biotechnology industry\n- Experience in interacting with regulatory agencies\n- Regulatory submissions experience\n- Experience interacting with senior regulatory agency representatives\n- Knowledge of global regulations\n- Familiarity in working with policies, procedures and SOPs\n- Understanding of drug development\n- Industry experience in manufacturing, process development, and testing (QC/QA)\n- Experience in analytical similarity or comparability assessments and development of associated packages\n- Leadership experience in a functional environment\n- Comprehensive understanding of Regulatory functional activities and how they affect projects and processes\n- Global regulatory experience with product filings\n- Experience interacting and communicating with senior executives and teams regarding strategic issues to ensure expectations are understood\n- Experience communicating and clearly presenting strategic and business issues\n- Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment\n- CMC-specific and analytical-specific regulatory knowledge and experience\n- Ability to understand and communicate scientific and clinical information\n- Ability to anticipate and prevent potential issues\n- Ability to manage and mentor others\n- Cultural awareness and sensitivity to achieve results across different regions", "date_new": "2012-05-04 19:30:47", "url": "http://www.amgen.jobs/xml/28441117/job", "country": "United States", "company": "Amgen", "title": "Regulatory Affairs Director (CMC Lead)", "reqid": "15571BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28441117}, {"country_short": "DEU", "city": "Field Based", "description": "Auto req 15587BR\nJob Posting Title Mitarbeiter/in wiss. Au\u00dfendienst H\u00e4m/Onk-Gebiet Kassel, G\u00f6ttingen, Braunschweig\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Germany\nLocation (City) Field Based\nAmgen Job Description Mitarbeiter im wissenschaftlichen Au\u00dfendienst H\u00e4matologie/Onkologie (m/w)\n\nGebiet: Kassel, G\u00f6ttingen, Goslar, Salzgitter, Braunschweig, Wolfsburg, Hildesheim, Hameln, Detmold, Paderborn\n\nDie Stelle ist zun\u00e4chst befristet f\u00fcr 2 Jahre zu besetzen\n\n\u2022 Sachkundige und umsichtige Beratung und Betreuung von Meinungsbildnern in Kliniken und Praxen in der H\u00e4matologie/Onkologie mit dem Ziel, die vereinbarten Umsatzziele im Gebiet zu erreichen\n\u2022 Darstellung des Nutzens unserer Produkte f\u00fcr Patienten und Mediziner auf der Basis wissenschaftlich belegter Daten/Studien\n\u2022 Umsetzung wissenschaftlicher Erkenntnisse in verk\u00e4uferische Resultate\n\u2022 Enge Zusammenarbeit mit den Teamkollegen und den Spezialisten aus Key Account- und Produktmanagement\n\nDer Mitarbeiter berichtet an den regionalen Au\u00dfendienstleiter Hem/Onc, Team Mitte.\nBasic Qualifications Fachlich:\n\u2022 Naturwissenschaftliches Studium w\u00fcnschenswert, evtl. ad\u00e4quate Ausbildung\n\u2022 3 bis 4 Jahre Berufserfahrung als Pharmareferent oder Pharmaberater im Spezialau\u00dfendienst\n\u2022 Vertriebsorientierte Ausbildung mit Berufserfahrung in kompetitiven M\u00e4rkten und Erfahrung im wissenschaftlichen Au\u00dfendienst\n\u2022 Idealerweise Kenntnisse in der H\u00e4matologie/Onkologie\n\u2022 Gute Englischkenntnisse\n\nPers\u00f6nlich:\n\u2022 Marketing- und vertriebsorientierte Denk- und Arbeitsweise\n\u2022 Sicheres und gewandtes Auftreten, \u00dcberzeugungsf\u00e4higkeit, Akzeptanz bei anspruchsvollen Gespr\u00e4chspartnern\n\u2022 Ausgepr\u00e4gte Kommunikations- und Teamf\u00e4higkeit\n\u2022 Reisebereitschaft und Pioniergeist", "date_new": "2012-05-03 18:03:35", "url": "http://www.amgen.jobs/xml/28403742/job", "country": "Germany", "company": "Amgen", "title": "Mitarbeiter/in wiss. Au\u00dfendienst H\u00e4m/Onk-Gebiet Kassel, G\u00f6ttingen, Braunschweig", "reqid": "15587BR", "state": null, "state_short": null, "location": "Field Based, DEU", "uid": 28403742}, {"country_short": "CAN", "city": null, "description": "Auto req 15574BR\nJob Posting Title Co-op Student: Hybridoma Subcloning and ESN Generation\nCareer Category College Job\nEmployee Subgroup Co-Op FT Salaried\nCountry (State/Region) Canada\nLocation (City) Burnaby\nAmgen Job Description Amgen British Columbia Inc., one of several research facilities operated by Amgen Inc., specializes in the discovery and development of human therapeutic antibodies. The research center, located in Burnaby, became part of Amgen with Amgen\u2019s acquisition of Abgenix, Inc. in April 2006. It employs approximately 65 people, including research scientists and a small support staff. Amgen is headquartered in the United States and has more than 17,000 staff members worldwide. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science\u2019s promise by bringing novel medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people\u2019s lives.\n\nThis project involves the discovery of novel human therapeutics or diagnostics using XenoMax\u2122 and Hybridoma technology. These two technologies allow identification of single immune cells from a large population that produces very high affinity antigen specific monoclonal antibodies. Another key component of the company is the Xenomouse\u2122, which is a proprietary transgenic mouse capable of producing fully human antibodies. The marriage of these technologies allows us to produce human antibodies against targets that would normally be considered self\u201d.\n\nThe candidate will be working in the Cell Biology/Subcloning group, which is responsible for using a FACs ARIA single cell sorter to isolate hybridoma\u2019s of interest. Hybridoma\u2019s are then scaled up and used to generate ESN supernatant, which will contain antibody of interest for further assays. The candidate will be responsible for reagent generation, maintenance of both FACS Caliburs and Aria, use of FACsAria for single cell sorting, cell culture, cell banking and harvesting of supernatants. The candidate will also be involved with our Robotics liquid handling platforms to aid in the above work.\n\nAnticipated Achievements:\n\u2022 Learn and implement basic cell culture techniques such as sterile technique, splitting cells, optimizing growth conditions, cryovial preservation of mammalian cells, media preparation for various cell lines\n\u2022 Gain experience in both FACS Calibur and Aria systems as well as Robotics\n\u2022 Gain much valuable experience in time organization and multitasking.\n\u2022 Become proficient in background searches and internet research.\n\u2022 Independently carry out projects depending on needs of company\n\n\nAll candidates will be subject to the verification of current college enrollment as well as a Canadian criminal records check prior to employment.\n\nAmgen retains the right to add or change the duties of the position at any time.\nAs an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace\nBasic Qualifications \u2022 Must be in the process of earning a Bachelors of Science degree in Chemistry, Molecular Biology, Biochemistry,  Biology/Microbiology, Life Sciences, Chemical Engineering, or related discipline.\n\u2022 Must be able to work for two consecutive four month terms with continued employment for the second term dependant on a positive performance review at the end of the first term.\n\u2022 Must be NSERC eligible\n.\n\nAmgen requires that all individuals applying for an internship or a co-op assignment at Amgen must meet the following criteria:\n\u2022 Must be 18 years or older\n\u2022 Must be a current full time student\n\u2022 Must have completed at least one full year of study\n\u2022 Must have not yet graduated\n\u2022 Must be in good academic standing within their majors and overall at their university\n\u2022 Must be enrolled in school the fall season following the potential internship or co-op assignment\n\u2022 Must not be employed at the time the internship starts\nPreferred Qualifications \u2022 Prefer students with previous lab experience.\n\u2022 Prior experience in tissue culture is desired, experience in immunology and immunofluorescence techniques would be preferred.\n\u2022 General knowledge of immunology & molecular biology would be an asset.\n\u2022 Excellent organizational skills and attention to detail.\n\u2022 Function effectively as part of a team.", "date_new": "2012-05-03 18:02:03", "url": "http://www.amgen.jobs/xml/28403685/job", "country": "Canada", "company": "Amgen", "title": "Co-op Student: Hybridoma Subcloning and ESN Generation", "reqid": "15574BR", "state": null, "state_short": null, "location": "Virtual, CAN", "uid": 28403685}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 15562BR\nJob Posting Title Sr Associate Biostatistical Programming\nCareer Category Clinical\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nUnited States - Washington\nLocation (City) Seattle\nSouth San Francisco\nThousand Oaks\nAmgen Job Description Position can be filled in Thousand Oaks, CA, San Francisco, CA or Seattle, WA\n\n\u2022Assist in the review of key study-related documents produced by other functions, e.g. case report form, data management plan, NONMEM specifications\n\u2022Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications\n\u2022Understand and execute department-, product- and study-level macros and utilities\n\u2022Write, test and validate product- and study-level macros and utilities\n\u2022Assist with study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings\n\u2022Provide input to and participate in intra-departmental and GBDS meetings\n\u2022Contribute to the continuous improvement of Global Biomedical Data Sciences (GBDS) and programming\n\u2022Assist in the review of GBDS policies, standard operating procedures and other controlled documents\n\u2022Provide support to and mentor more junior programmers\n\u2022Interface with outsourcing partners and vendors\n\u2022Attend external professional organizations, conferences, training and/or meetings\n\nKnowledge\n\u2022Computer programming, preferably SAS or other procedural languages\n\u2022Fundamentals of Project Planning and Management\n\u2022Drug Development Process & Operations\nBasic Qualifications \u2022BS/BSc in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject\n\u2022Three (3) years relevant career experience\nPreferred Qualifications \u2022MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject\n\u2022Drug Development (pre-, early, late and/or observational) in related industries or academic research\n\u2022Four (4) years relevant career experience", "date_new": "2012-05-03 18:01:32", "url": "http://www.amgen.jobs/xml/28403680/job", "country": "United States", "company": "Amgen", "title": "Sr Associate Biostatistical Programming", "reqid": "15562BR", "state": "California", "state_short": "CA", "location": "Seattle, CA", "uid": 28403680}, {"country_short": "CAN", "city": null, "description": "Auto req 15576BR\nJob Posting Title Co-op Student: Cell Based Screening & Assay Development\nCareer Category College Job\nEmployee Subgroup Co-Op FT Salaried\nCountry (State/Region) Canada\nLocation (City) Burnaby\nAmgen Job Description Amgen British Columbia, one of Burnaby\u2019s premier biotechnology companies, is focused on the development and commercialization of therapeutic antibody products targeting disease prevention and treatment. The company's antibody technology platform enables the rapid generation and selection of high affinity, fully human antibody product candidates to essentially any disease target appropriate for antibody therapy.\n\nWorking in partnership with our U.S. based parent company, Amgen Inc., Amgen British Columbia leverages its leading technology, flexible manufacturing capabilities and a network of partnerships for the discovery, development and manufacture of therapeutic antibodies for serious health conditions. For more information, please visit our website at www.amgen.com.\n\nJob Summary:\n\nThe student will be part of a high-energy, fast paced team responsible for cell screening and assay development in our antibody generation process. The team utilizes Flow Cytometry and FMAT as the screening platforms and also utilizes high capacity liquid handling robotics. In addition to becoming proficient in our screening platforms and process, the student is expected to maintain a variety of cell lines and is responsible for cell transfections. The student will have the opportunity to develop novel assays to assist in characterizing lead antibodies.\n\nEssential Functions:\n\n\u2022 Performs a variety of Cell-based assays:\n\u2022 assays used to characterize the immune response in immunized animals\n\u2022 high-throughput cell screens to identify antigen specific antibodies\n\u2022 functional assays to characterize antibodies for epitope specificity, ligand blocking and species reactivity\n\u2022 Gain strong working knowledge of Flow Cytometry, FMAT and ELISA\n\u2022 Critically evaluate data and present results to the team\n\u2022 Tissue culture and transfections\n\u2022 Optimize/develop assays\n\n\nAll candidates will be subject to the verification of current college enrollment as well as a Canadian criminal records check prior to employment.\n\nAmgen retains the right to add or change the duties of the position at any time.\nAs an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace\nBasic Qualifications \u2022 Must be in the process of earning a Bachelors of Science degree in Chemistry, Molecular Biology, Biochemistry,  Biology/Microbiology, Life Sciences, Chemical Engineering, or related discipline.\n\u2022 Must be able to work for two consecutive four month terms with continued employment for the second term dependant on a positive performance review at the end of the first term.\n\u2022 Must be NSERC eligible.\n\nAmgen requires that all individuals applying for an internship or a co-op assignment at Amgen must meet the following criteria:\n\u2022 Must be 18 years or older\n\u2022 Must be a current full time student\n\u2022 Must have completed at least one full year of study\n\u2022 Must have not yet graduated\n\u2022 Must be in good academic standing within their majors and overall at their university\n\u2022 Must be enrolled in school the fall season following the potential internship or co-op assignment\n\u2022 Must not be employed at the time the internship starts\nPreferred Qualifications \u2022 Prefer students with previous lab experience.\n\u2022 General knowledge of immunology & molecular biology would be an asset.\n\u2022 Excellent organizational skills and attention to detail.\n\u2022 Function effectively as part of a team.", "date_new": "2012-05-03 18:01:15", "url": "http://www.amgen.jobs/xml/28403677/job", "country": "Canada", "company": "Amgen", "title": "Co-op Student: Cell Based Screening & Assay Development", "reqid": "15576BR", "state": null, "state_short": null, "location": "Virtual, CAN", "uid": 28403677}, {"country_short": "CAN", "city": null, "description": "Auto req 15575BR\nJob Posting Title Co-op Student: In Vivo\nCareer Category College Job\nEmployee Subgroup Co-Op FT Salaried\nCountry (State/Region) Canada\nLocation (City) Burnaby\nAmgen Job Description Amgen British Columbia, one of several research facilities operated by Amgen Inc., specializes in the discovery and development of human therapeutic antibodies. The research center, located in Burnaby, became part of Amgen with Amgen\u2019s acquisition of Abgenix, Inc. in April 2006. It employs approximately 50 people, including research scientists and a small support staff. Amgen is headquartered in the United States and has more than 17,000 staff members worldwide. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science\u2019s promise by bringing novel medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people\u2019s lives.\n\nJob Summary\n\nThe successful candidate will work as part of the Preclinical group at Amgen British Columbia Inc. The student will be responsible for performing a variety of in vivo and in vitro cell biology techniques used to evaluate potential cancer targets and oncology drug candidates. Experiments will be conducted in a semi-independent fashion under supervision. There are a variety of projects currently ongoing in the Preclinical group and these projects change frequently. The student will be involved in some or all of these projects as needed.\n\nEssential Functions\n\nThe job involves assisting researchers in all aspects of in vivo and in vitro studies. There will be some routine aseptic cell culture and flow cytometry. In addition, depending on current projects student may learn some or all of the following:\n\nIn vivo studies: study design, data collection, treatment formulation prep, animal handling, tumor measurement and data analysis.\n\nIn Vitro studies: ELISA, SDS-PAGE, Western Blots and cell-based assays evaluating cytokine release, T cell or NK cell activation, proliferation or apoptosis.\n\n\nAll candidates will be subject to the verification of current college enrollment as well as a Canadian criminal records check prior to employment.\n\nWe request that all applicants include a cover letter with their resume when they apply. Applicants without a cover letter may not be considered for the position.\n\nAmgen retains the right to add or change the duties of the position at any time.\nAs an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace\nBasic Qualifications \u2022 Must be in the process of earning a Bachelors of Science degree in Chemistry, Molecular Biology, Biochemistry,  Biology/Microbiology, Life Sciences, Chemical Engineering, or related discipline.\n\u2022 Must be able to work for two consecutive four month terms with continued employment for the second term dependant on a positive performance review at the end of the first term.\n\u2022 Must be NSERC eligible\n.\n\nAmgen requires that all individuals applying for an internship or a co-op assignment at Amgen must meet the following criteria:\n\u2022 Must be 18 years or older\n\u2022 Must be a current full time student\n\u2022 Must have completed at least one full year of study\n\u2022 Must have not yet graduated\n\u2022 Must be in good academic standing within their majors and overall at their university\n\u2022 Must be enrolled in school the fall season following the potential internship or co-op assignment\n\u2022 Must not be employed at the time the internship starts\nPreferred Qualifications \u2022 Suitable for a first or second work term as all training will be provided.\n\u2022 General knowledge of In Vivo studies, immunology & molecular biology would be an asset.\n\u2022 High attention to detail and able to comply with written procedures.\n\u2022 Strong written and oral communications skills in English.\n\u2022 Excellent organizational skills.\n\u2022 Function effectively as part of a team.", "date_new": "2012-05-03 18:01:04", "url": "http://www.amgen.jobs/xml/28403671/job", "country": "Canada", "company": "Amgen", "title": "Co-op Student: In Vivo", "reqid": "15575BR", "state": null, "state_short": null, "location": "Virtual, CAN", "uid": 28403671}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15517BR\nJob Posting Title Principal Engineer - Drug Product Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This is a high level position for a subject matter expert within the Drug Product Engineering Organization. They will be responsible for providing scientific and technical leadership and strategic direction to process development of small molecule dosage forms. They will drive development and implementation of key organizational business processes including QbD approach, GMP expectation and process development by interacting with internal, pharmaceutics, quality and regulatory functions. This is a high visibility technical/leadership position within a growing team.\nSpecific responsibilities are described below\n\u2022 Perform process development, characterization and scale-up for late phase drug candidates\n\u2022 Define manufacturing process and its control strategy\n\u2022 Support design, execution and review of process performance qualification runs at commercial manufacturing site\n\u2022 Perform process monitoring, trending and improvement for commercial drug products\n\u2022 Support GMP productions\n\u2022 Draft relevant CMC sections in marketing applications and/or annual updates\n\u2022 Enable project progression by cross-functional collaboration and documentation of study results/findings into reports\n\u2022 Serve as technical expertise and consultation for internal and external manufacturing sites\n\u2022 Develop process analytical technology (PAT) applications\napplications\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications The ideal candidate will have extensive experience in process characterization, scale-up, technology transfer, validation, and CMC preparation of pharmaceutical dosage forms to support product filing and launch. The primary focus is oral dosage forms. Experienced in injectable dosage forms is a big plus.\nSuccess in this role is strongly dependent upon the individual's ability to effectively communicate and collaborate with team members and/or external partners (e.g., CMO). The candidate should have a collaborative mindset and strong leadership/communication skills for sharing insights and best practice and diligently focus on accomplishing scheduled assignments in a timely manner.\nThe talented individual we seek will demonstrate a thorough understanding of dosage form development, regulatory & quality considerations, and possess hands-on experience with processing equipment.\n\nQualifications should include:\n\u2022 Advanced degree in Biochemical Engineering, Biotechnology, or Pharmaceutical Sciences and 8 years relevant work experience in process/formulation development of pharmaceutical dosage forms\n\u2022 Knowledge of the drug development process\n\u2022 Leadership experience of progressively increased scope.\n\u2022 Strong interdisciplinary project management skills.\n\u2022 Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.\n\u2022 Should have strong communication skills, both written and oral.\n\u2022 Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans.\n\u2022 Team leadership, management, and facilitation skills are required.", "date_new": "2012-05-02 18:26:35", "url": "http://www.amgen.jobs/xml/28331570/job", "country": "United States", "company": "Amgen", "title": "Principal Engineer - Drug Product Engineering", "reqid": "15517BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28331570}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15569BR\nJob Posting Title Clinical Research Sr Medical Scientist - Nephrology\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Research Senior Medical Scientist is responsible for:\n\n- Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Participating and providing clinical input into safety and regulatory interactions\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols)\n- Interpret clinical trial data\n- Participate in safety assessments\n- Review and provide clinical scientific input to TLGs and safety narratives\n- Review scientific literature\n- Initiate database analyses to support commercial/clinical objectives\n- Contribute to the preparation of clinical study reports and regulatory submissions\n- Participate in interactions with regulatory agencies\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL\n- Identify new clinical research opportunities\nBasic Qualifications - MD\nPreferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent\n- Two (2) or more years of clinical research experience and/or basic science research\n\nKnowledge:\n\n- Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Medical knowledge in the relevant therapeutic area\n- Sound scientific and clinical judgment\n- Familiarity with regulatory agency organization, guidelines, and practices\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-05-02 18:26:35", "url": "http://www.amgen.jobs/xml/28331569/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Sr Medical Scientist - Nephrology", "reqid": "15569BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28331569}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15510BR\nJob Posting Title Global Safety Sr Medical Scientist\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role provides content and technical support to the GST in the evaluation of safety data and production of GST deliverables under the supervision of the Global Safety Officer (GSO). Due to significant experience in the role from a scientific and technical perspective this role requires increased independence and leadership with less direct supervision of content driven activities by the GSO. The incumbent must be able to serve as GSO delegate for internal and potentially external Amgen meetings (Data Monitoring Committee, Ad-com representation).\n\nKey Activities:\n\nSupport Global Safety Officer (GSO) in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology\n\nResponsible for producing presentations for Product Safety Review Meetings (PSRM) and other scientific presentations under the guidance of the GSO\n\nContribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables\n\nSafety content and expertise in support of Investigator Meetings, Data Monitoring Committees and DRTs, responses to regulatory authorities, safety sections of clinical trial documents\nBasic Qualifications MD or DO degree from an accredited medical school\n\nCompletion of an accredited medical or surgical residency\nOR\nClinical experience in either an accredited academic setting or private practice (including hospital based) setting\nPreferred Qualifications Advanced Education in Hematology strongly preferred.\n\nCurrent registered medical license\n\nBoard certified or Board eligible\n\nAccredited fellowship or clinical experience\n\nClinical experience, including training\n\nDrug safety experience", "date_new": "2012-05-02 18:26:31", "url": "http://www.amgen.jobs/xml/28331567/job", "country": "United States", "company": "Amgen", "title": "Global Safety Sr Medical Scientist", "reqid": "15510BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28331567}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15390BR\nJob Posting Title Sr Regional Medical Liaison\nCareer Category Medical Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position is a field-based position for the Bone therapeutic area Regional Medical Liaison (RML) group within the Scientific Affairs organization. The territory covers Idaho, Montana, Utah, and Colorado.\n\nThe Senior Regional Medical Liaison (Sr RML) will interact with osteoporosis healthcare decision makers to communicate and advance the scientific platform as aligned with Amgen's corporate goals and objectives. The Sr RML is an integral position in assuring accurate, clear and valued information regarding our science and products to multiple levels within the medical community. The successful Sr RML will communicate complex cutting edge scientific information and research concepts to healthcare decision makers including but not limited to those at Academic Medical Centers. The role may also include providing clinical and economic value information to payers and formulary decision makers. The Senior RML is also responsible for identifying and training members of Amgen's speakers\u2019 bureau to ensure they are updated on new data. In addition, the Senior RML will provide feedback based on field interactions and scientific support consistent with Amgen research and product support.\n\nThe Sr RML will:\n\u2022 Interact with healthcare thought leaders to communicate and advance the scientific platform as aligned with Amgen\u2019s corporate goals and objectives\n\u2022 Communicate complex cutting edge, scientific information and research concepts to healthcare decision makers, including but not limited to, those at Academic Medical Centers\n\u2022 Provide clinical and economic value information to payers and formulary decision makers\n\u2022 Train members of Amgen\u2019s speakers\u2019 bureau and ensure they are updated on new data\n\u2022 Support Amgen sponsored research\n\u2022 Provide feedback based on field interactions with healthcare thought leaders\n\u2022 Provide scientific support, consistent with the RML compliance standards, for sales, corporate account, and other matrix colleagues\u2019 facilitated HCP inquiries\n\u2022 Foster scientific relationships between Amgen and fellows in training\n\u2022 Lead and/or participate on committees or project teams that support RML strategies and tactics as delegated by RML leadership\n\u2022 Seek out opportunities to support the RML value proposition and achieve results and set an example for others to follow by consistently demonstrating Amgen Values and Leadership Attributes.\n\u2022 Demonstrate tact and organizational savvy when communicating and interacting with others\n\nThe Sr RML will model openness and innovation through words, actions, and decisions. Amgen RMLs share learning including entrepreneurial and innovative ideas with others and hold self accountable for performance as well as encouraging others to achieve and be accountable for performance.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nPreferred Qualifications 7 or more years of experience in a medically related field, including 1 or more years focused on clinical practice, clinical research, or medical research. Experience in a medically related field can include post doctoral training (i.e., residencies and/or fellowships).\n3 + years in a medical science liaison role in a biotech or pharmaceutical company\nCurrent Amgen experience in Scientific Affairs or Medical Affairs experience at a biotech or pharmaceutical company\nOsteoporosis and /or metabolic bone therapeutic expertise area knowledge", "date_new": "2012-05-02 18:26:30", "url": "http://www.amgen.jobs/xml/28331566/job", "country": "United States", "company": "Amgen", "title": "Sr Regional Medical Liaison", "reqid": "15390BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28331566}, {"country_short": "USA", "city": "West Greenwich", "description": "Auto req 15543BR\nJob Posting Title Sr Mgr Supply Chain\nCareer Category Supply Chain\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen Job Description The Senior Manager of Supply Chain will be responsible for the successful management of the Supply Chain team including bulk drug substance end to end Supply Chain activities, including site strategic planning, production planning and raw material procurement.\n\nResponsibilities include:\n\n\u2022 Ownership of site production planning, including coordination, communication, key assumption development and scenario planning\n\u2022 Continuously drive improvement in Supply Chain process\n\u2022 Actively monitor and mitigate supply related risks, including external and internal influences\n\u2022 Successfully lead and build the Supply Chain team\n\u2022 Create strong partnerships with corporate counterparts and global stakeholders\n\nPosition Specific Tasks:\nStrategic Influence\n\u2022 Independently determines planning approach to managing daily operations, guided by Amgen policies and management guidance\n\u2022 Develops and communicates plans/objectives to team\n\u2022 Contributes to site and functional strategy\n\u2022 Ensures consistent practices across network\n\u2022 Delivers results through professional employees\n\u2022 Develops and monitors Department budgets and goals\n\u2022 Provides guidance and technical direction to team and site\n\u2022 Institutes standards for Supply Chain management and Strategic Planning\n\nRelationship Focus\n\u2022 Develops relationships with cross-functional/network at various management levels to resolve issues and optimize overall Supply Chain\n\u2022 Takes accountability of the day-to-day Supply Chain operations\n\u2022 Partners with Operational Excellence leaders to ensure alignment on commercialization and tech transfer processes\n\u2022 Partners with TA Heads, GOLs, ED Ops Improvement, Corporate Alliance Management to ensure alignment on key cross-functional/product processes and communication\n\nLeads Supply Chain Function\n\u2022 Provides people/performance management, coaching and mentoring of staff\n\u2022 Directs staff on strategic and tactical content/approach\n\u2022 Builds, maintain, and retain successful team\n\u2022 Elevates issues in a timely manner\n\u2022 Focuses on Operational Excellence as a means of driving continuous improvement\nBasic Qualifications Doctorate degree and 2 years of directly related experience\n\nOR\n\nMaster\u2019s degree and 6 years of directly related experience\n\nOR\n\nBachelor\u2019s degree or and 8 years of directly related experience\n\nOR\n\nAssociate\u2019s degree and 10 years of directly related experience\n\nOR\n\nHigh school diploma / GED and 12 years of directly related experience\n\nAND\n\n2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Bachelor\u2019s degree in business, engineering, life or physical sciences;\n\u2022 Advanced degree in science, engineering, or business (MBA).\n\u2022 Skills and experience to include:\no Demonstrates the Amgen\u2019s Values\no Excellent interpersonal skills\no Exceptional ability to work cross-functionally and build collaborative working relationships\no Strong communication and presentation skills (verbal & written) ; ability to interface effectively with Ops Senior and Executive Management to resolve issues\no Excellent communication capabilities vertically and horizontally; ability to leverage contact network to enable cross-functional collaboration; ability to influence\no Comfort with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making\no Certified or experience in process improvement methodologies such as Lean/Six Sigma\no Planning / negotiation / coaching & project management skills\no Results oriented, strong adherence to timelines\no Excellent ability to translate knowledge and build high performing teams\no Strong analytical and problem solving skills\no Self-leadership & motivation", "date_new": "2012-05-01 18:59:14", "url": "http://www.amgen.jobs/xml/28303394/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Supply Chain", "reqid": "15543BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 28303394}, {"country_short": "GBR", "city": "Cambridge", "description": "Auto req 15496BR\nJob Posting Title Regional Account Manager - Oncology - East & West Midlands\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United Kingdom\nLocation (City) Cambridge\nField Based\nUxbridge\nAmgen Job Description Purpose:\nDiagnosing requirements and assuming responsibility for evaluating, developing and commercialising external opportunities and minimising threats at a local level in line with Amgen strategy. Ensuring optimal usage of our current and future portfolio.\nPlans, organises and executes activities to ensure access to funding and sales of our products to meet regional and national goals.\nBasic Qualifications Accountabilities:\n\nConducts analysis and assessment of accounts to ensure an understanding of issues, key opinion leaders, stakeholders, health priorities, PCT Commissioning, procurement activities, SHAs and/or regional networks.\n\nConducts an analysis of brand strategies to ensure account plans are aligned and prioritised.\n\nProfiles and validates key customers.\n\nInputs into the prioritisation of customers to refine segmentation plan.\n\nWorks effectively with market research and HE team to assess market opportunity.\n\nProduces a plan of action to ensure achievement of account priorities and regional and national brand strategy.\n\nInvolves key internal stakeholders in preparation of account plans to ensure alignment and prioritisation of activities.\n\nSupports identification of opinion leaders and develops engagement plan\n\nEnsures all activities agreed within the account plans are implemented to completion within time, cost, compliance and quality constraints.\n\nManaged Entry \u2013 work with payers prior to the launch of new products to ensure an optimum environment.\n\nTranslates national plan to develop regional plan of action.\n\nDevelops metrics for success and tracks progress relative to targets.\n\nMarket Access \u2013 ensure an optimum environment for the prescribing of Amgen products both current and future\n\nService Development/Implementation \u2013 Accelerate the development and implementation of high quality local services and ensure that all patients who could benefit from Amgen products can gain access to licensed products\n\nMaintains effective collaboration within own and cross-functional teams to ensure alignment, progress updates and knowledge share.\n\nAll role activities completed to meet team/Amgen standard operating procedures and quality standards.\n\nCompletes all administration and reporting requirements, e.g. CRM, and ensure compliance with Amgen record retention policy.\nPreferred Qualifications Preferred Qualifications Essential\n\n- Extensive experience of working the wider health economy ie, PCT\u2019s, SHA and Cancer Networks in order to make funding available for both new and in line products.\n- Proven hospital only sales experience\n- A proven track record of consistently high performance in a hospital sales environment\n- Experience of working in a primary care (PCO) environment", "date_new": "2012-05-01 18:58:34", "url": "http://www.amgen.jobs/xml/28303386/job", "country": "United Kingdom", "company": "Amgen", "title": "Regional Account Manager - Oncology - East & West Midlands", "reqid": "15496BR", "state": null, "state_short": null, "location": "Cambridge, GBR", "uid": 28303386}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15447BR\nJob Posting Title Senior Manager Information Systems\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Senior Manager Information Systems will work in the Engineering Information Systems department within Operations IS (OIS), supporting the Global Engineering function under Operations. He or she will lead a team of IS professionals with overall responsibilities of IS service ownership to implement and support Engineering business systems & solutions that achieve business objectives & strategy, meet user and regulatory requirements, and adhere to approved IS standards and procedures.\n\nThe candidate will demonstrate an understanding of the functional area business models, processes, and priorities, and leverage that knowledge in the delivery of production support and enhancement of existing systems and the implementation of new IS solutions. He or she will participate in and/or facilitate cross-functional and cross site team meetings to discuss and optimize business process automation and will present key findings to Information Systems and business management. He or she will coordinate the efforts of other Information Systems groups in the delivery of support for the assigned functional areas.\n\nResponsibilities include Client relationship management, Portfolio and project management, developing, supporting, and maintaining business & IS Strategy, client service request management, process and systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, and developing and presenting business cases for proposed solutions. Strong emphasis on 'As Is' process and systems mapping, 'To Be' visioning, and identifying and articulating business and IS functional gaps, and Project Management and execution.\nResponsible for coordinating and working with Amgen IS Shared services groups & supply chain, and external service providers and business partners in support of Engineering IS systems and project portfolio, services optimization, managing service level agreements, internal IS and client coordination, service monitoring and reporting as well as user interface.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\n\nAND\n2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications Bachelor's degree in Information Systems, Computer Science, Engineering, Business Administration or the Life Sciences\n\n10+ years of related experience, preferably in the biotechnology or pharmaceutical industries\n\n5+ years of experience managing staff; demonstrated ability to build and lead teams in a staff as well as matrix environment; experience leading large, cross-functional initiatives\n\nStrong leadership, communication, project management, analysis, customer service, change management and interpersonal skills\n\nKnowledge of and experience in applying mainstream IS concepts, technologies, and methodologies\n\nDemonstrated strong process and business analysis skills\n\nExcellent verbal, written, interpersonal communication, and presentation skills, including the ability to set managerial context for complex issues\n\nDemonstrated ability to facilitate the utilization of IS resources within and between multiple IS organizations to meet business objectives\n\nExperience with FDA regulations governing computer system validation and operation\n\nExperience in supporting Engineering IS systems covering the following business processes:\n\nMaintenance Management, Document/Drawing Management, Capital Planning, Capital Project Management and Controls, Facility Management, Calibration Management, and Global Metrics and reporting\n\nProfessional certifications related to quality, project management, and/or IT service management, and/or membership in a related professional organization such as ISPE, ISA, PMI, or ASQ\n\nKnowledge of the SDLC methodologies including Unified Modeling Language (UML), Rational Unified Process (RUP)\n\nDemonstrated disciplined Project Management in IS setting\n\nPractical experience in performing audits or supporting regulatory inspections\n\nExperience working in a regulated industry, preferably pharmaceutical industry\n\nKnowledge and experience in applying FDA cGxP and ISPE GAMP guidance\n\nProfessional certifications related to quality, project management, and/or IT service management", "date_new": "2012-05-01 18:56:06", "url": "http://www.amgen.jobs/xml/28303299/job", "country": "United States", "company": "Amgen", "title": "Senior Manager Information Systems", "reqid": "15447BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28303299}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14383BR\nJob Posting Title Clinical Research Medical Director - Vectibix\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Research Medical Director is responsible for:\n\n- Supporting the development, execution and communication of the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Supporting the development of key scientific external relationships with opinion leaders\n- Participating and providing clinical input into safety and regulatory interactions\n\nKey Activities:\n\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Interpret clinical trial data\n- Participate in safety assessments\n- Participate in interactions with regulatory agencies\n- Author CSRs, publications and regulatory submissions\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL\n- Identify new clinical research opportunities\n- Support in-licensing and out-licensing activities and partner relationships\n- Support product lifecycle management for new indications as directed by Global Development Leader\n- Provide clinical content input to:\n- Regulatory interactions and documents\n- Safety interactions and documents\n- Materials to be used in Scientific Affairs\n- Materials to be used by the Commercial Organization\nBasic Qualifications - MD\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\nPreferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent\n- Experience in Oncology\n- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\n- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n- prior oncology clinical research / experience\n\nKnowledge\n\n- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Sound scientific and clinical judgment\n- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- Demonstrated ability as a medical expert in a complex matrix environment\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-04-30 18:51:03", "url": "http://www.amgen.jobs/xml/28273713/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Director - Vectibix", "reqid": "14383BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28273713}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15534BR\nJob Posting Title Regulatory Affairs Mgr (Scientific Writer)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.\n\nJob Summary:\n- Draft scientific, CMC, and regulatory documents that conform to global regulatory requirements, Amgen and industry standards, and accepted templates.\n- Manage review and approval of scientific, CMC, and regulatory documents; engage members of cross-functional teams to address and resolve issues in accordance with established timelines.\n- Ensure the accuracy, adequacy, and consistency of documents.\n- Provide writing expertise to project teams.\n\nKey Activities:\n- Write Scientific, CMC, and Regulatory Documents\n- Independently write documents in support of product registrations and global filings, eg, briefing documents, responses to regulators\u2019 questions, and Quality-related sections of INDs, CTAs, Analytical Packages, and CTDs.\n- Participate in the development of study timelines for regulatory documents.\n- Implement quality control for review and finalization of documents.\n- Ensure finalized documents are filed and archived appropriately.\n- Assist with process development initiatives to meet internal needs.\n- Maintain Writing Expertise and Awareness of Regulatory Environment\n- Seek opportunities to continue developing writing and editorial skills.\n- Keep abreast of regulatory requirements that affect work projects.\n- Collaborate with multidisciplinary teams across global regions.\n- Negotiate final content and format of dossiers.\n- Represent Biosimilars Regulatory Affairs on committees, as requested\nBasic Qualifications - Doctorate degree\nOR\n- Master\u2019s degree and 3 years of directly related experience\nOR\n- Bachelor\u2019s degree and 5 years of directly related experience\nOR\n- Associate\u2019s degree and 10 years of directly related experience\nOR\n- High school diploma / GED and 12 years of directly related experience\nPreferred Qualifications - Degree in Life Sciences or related field\n- Experience in the biosimilars/ biotechnology industry\n- Regulatory submissions experience\n- Regulatory knowledge of global regulations\n- Working with policies, procedures, and SOPs\n- Understanding of drug development\n\nKnowledge and Skills\n- Ability to analyze data, and to collaborate with subject matter experts outside one\u2019s own areas of scientific expertise.\n- Good knowledge and experience with time management and timeline development.\n- Ability to work with remote workers.\n- Attention to detail.\n- Flexibility.\n- Strong oral and written communication skills.\n- Ability to understand and communicate scientific and CMC information.\n- Ability to discern areas of potential concern and communicate concerns effectively to manager.\n- Cultural awareness and sensitivity to achieve results across different regions.", "date_new": "2012-04-30 18:51:01", "url": "http://www.amgen.jobs/xml/28273711/job", "country": "United States", "company": "Amgen", "title": "Regulatory Affairs Mgr (Scientific Writer)", "reqid": "15534BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28273711}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15527BR\nJob Posting Title Mgr District Sales BHBU - White Plains, NY\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - New York\nLocation (City) Field Based\nAmgen Job Description Territory # 51401, White Plains, NY; covering White Plains-Paramus, NJ; Spring Valley, NY; Bronx N, NY; Wayne, NJ; Bronx S, NY; Hackensack, NJ; Yonkers, NY; Bridgeport, CT; Stamford, CT\n\nThis position will require strong ability to collaborate cross-functionally with other Amgen business units including District Sales Mangers, Regional Sales Directors and Corporate Account Managers. Candidates will need to fully understand the Primary Care/OBGYN/endocrinology and osteoporosis marketplace, develop business plans for their geography and implement national sales strategies and programs.\n\nAdditional Responsibilities and Duties Include:\n\n- Track the progress of marketing messages and programs\n- Provide feedback to district teams on the marketing, allocating, monitoring, and leveraging of internal and external resources (e.g., discretionary spend)\n- Manage district teams to maximize their performance and help achieve/exceed sales and budget targets\n- Screen, interview, and hire candidates\n- Ensure compliance with training\n- Demonstrate the appropriate coaching and counseling to prepare individuals for future development\n- Conduct annual and on-going performance reviews and competency assessments\n- Communicate and coordinate with both district and cross-functional teams (e.g., Marketing, Finance, other Business Units)\n- Share best practices with direct reports and peers\n- Coordinate and/or participate in cluster teams\n- Conduct district sales meetings to guide districts\n- Develop local Opinion Leader relationships to achieve aligned objectives\nBasic Qualifications - BS / BS degree is required\n- 8+ years pharmaceutical or biotech sales experience\n- 2+ years sales management experience (or management development program)\nPreferred Qualifications - 3+ years of specialty sales experience (Primary Care/OBGYN/endocrinology and osteoporosis marketplace)\n- Experience in biologics\n- Buy and bill model experience\n\nAdditional Competencies:\nAbility to consistently and objectively recognize and promote success behaviors, as well as diagnose and change unsatisfactory behaviors through effective coaching; ability to leverage market & customer knowledge to strategically target messages, resources, and activities within the territory; demonstrates knowledge of local payor coverage; ability to understand and articulate clinical concepts, data, and conclusions; demonstrated ability to utilize clinical information to effectively address customer questions and objections; ability to recruit candidates that meet the minimum job criteria; interviews and hires sales representatives that are capable and committed to fulfilling the job requirements; strong sense of responsibility and demonstrated self-discipline; setting appropriate short term and long term objectives; demonstrated success in communicating & collaborating with sales staff, peers, business unit counterparts in an effective and timely manner.", "date_new": "2012-04-30 18:49:33", "url": "http://www.amgen.jobs/xml/28273677/job", "country": "United States", "company": "Amgen", "title": "Mgr District Sales BHBU - White Plains, NY", "reqid": "15527BR", "state": "New York", "state_short": "NY", "location": "Field Based, NY", "uid": 28273677}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15448BR\nJob Posting Title Sr Project Mgr - Product Strategy Team\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\n\nThe Sr. Project Manager provides project management support & leadership to PST sub-teams, sub-team projects and subprojects and is accountable to the Global Project Manager, Product Strategy Team & / or Research team leaders, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects.\n\nKey Responsibilities\n\nTeam Leadership - Provide operational leadership in team and/or sub-team meetings and identify cross-functional implications, risks and issues. Elevate sub-team issues and work to overcome implementation obstacles at the functional level. Ensure strategic alignment between sub-teams and PST / Research project teams. Drive effective sub-team operations, including goal setting, sub-team charters, functional mgmt reviews, etc. and ensure that all goals and objectives are well understood by the various functional areas.\n\nCross Functional Communication - Provide timely, accurate communication between teams / sub-teams and functional departments. Communicate appropriate information on functional team status & issues to stakeholders.\n\nStrategic Thinking - Actively participate in all PST sub-team discussions and ensure all views are heard and aligned. Assist teams and sub-team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan. Coordinate with the teams and the sub-teams to ensure sub-team plan alignment with the Project strategic plans.\n\nRisk Management - Conduct functional team-level risk assessment and scenario planning to support sub-team issues. Proactively drive development of contingency and/or risk-mitigation plans at the sub-team level.\n\nResource Planning - Provide information to assist with resource planning at the sub-team level and elevate resource issues as needed. Identify and reconcile resource issues across sites or functions that may impact global coordination.\n\nProject Management Process - Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate sub-team plans into actionable and measurable tasks. Follow up on action items from sub-team meetings. Establish and achieve project standards for work quality and quantity.\n\nProduct Team Deliverables - Ensure adherence to Commercialization and governance processes at the sub-team level. Assist in the development/update of key Commercialization sub-team deliverables, e.g., sub-team plans, etc. Generate periodic updates and/or prepare formal presentations to line managers and/or others for all management reporting. Provide detailed data support for portfolio management/DA processes. Drive the development of functional plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan.\nBasic Qualifications Doctorate degree and 2 years of directly related experience\nOR\nMaster\u2019s degree and 6 years of directly related experience\nOR\nBachelor\u2019s degree and 8 years of directly related experience\nOR\nAssociate\u2019s degree and 10 years of directly related experience\nOR\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications - Demonstrated experience in project management, business analysis, or managing and/or coordinating domestic and/or international product development\n\n- Project Management Professional (PMP) certification desired\n\n- MS, MBA or PhD\n\n- 7 or more years of experience in cross-functional pharmaceutical development project teams and/or experience with project management practice within the pharmaceutical industry\n\n- Experience working on late stage product development\n\n- Experience working on BLA/NDA regulatory filing activities\n\n- Experience in oncology drug development\n\n- Excellent verbal and written skills", "date_new": "2012-04-29 19:44:08", "url": "http://www.amgen.jobs/xml/28264320/job", "country": "United States", "company": "Amgen", "title": "Sr Project Mgr - Product Strategy Team", "reqid": "15448BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28264320}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15493BR\nJob Posting Title Specialist IS Business Systems Analyst - Field Sales support\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Business Analyst within the North American Commercial Operations Information Systems (NACOIS) Field Sales Solutions will be responsible for partnering with the Sales Operations and Field Force to identify business needs and translate them into system requirements that can be successfully delivered by IS. This Business Analyst will manage clients\u2019 demand, represent their interests, and will be accountable for coordinating efforts with vendors and IS partners (Global Commerial Operations IS Shared Services, Enterprise Business Intelligence (EBI)- Center of Excellence, and other Enterprise Systems groups) in the implementation and support of Business Intelligence solutions for Sales Operations and Field.\n\nResponsibilities include:\n\n\u2022 Plan and facilitate end-user sessions intended to surface requirements\n\u2022 Translate business needs into functional/non-functional system requirements\n\u2022 Presents designs, prototypes, and evolving solutions to assist with solution definition\n\u2022 Accountable for documenting detailed business requirements and business rules (use cases)\n\u2022 Accountable for documenting System Requirements Specifications\n\u2022 Analyzes and documents data requirements, flow and interdependencies\n\u2022 Participates in initial solution design\n\u2022 Ensures business requirements are met; participates in design reviews, develops traceability matrices to ensure requirements are developed, tested and delivered\n\u2022 Assesses impact that business requests, process and data changes may have on system(s)\n\u2022 Analyzes and recommend changes to improve business and IS processes\n\u2022 Ensures requests/projects are reviewed and approved through appropriate governance (Reporting Governance, GCOIS Portfolio Management, Global Commercial Operations Senior Leadership Team, ILM)\n\u2022 Acts as a project manager for incremental releases:\no Develop project plan and schedule\no Escalates and mitigates issues and risks\no Consistently communicate the status of projects and requests\no Ensures appropriate priorities are assigned to critical tasks\no Develops test plan in partnership with IS peers (SIT) and Business (UAT)\no Ensures test plan is successfully executed\no Ensures clients expectations, project deliverables and milestones are met\n\u2022 Forecasts and proactively communicate resource demand to Enterprise Systems groups\n\u2022 Manages solution testing (IS and Business) and validation efforts\n\u2022 Develops strong subject matter expertise on business processes and related systems, and becomes a trusted partner and advisor to clients and IS partner teams.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Bachelor\u2019s degree in Information Technology, Computer Science, Engineering, or Life Sciences\n\u2022 Master\u2019s degree (Business, Information Systems, Project Management)\n\u2022 3+ years IS experience working specifically on Business Intelligence (BI) solutions, preferably within bio/pharma industry\n\u2022 IS experience supporting field sales\n\u2022 Professional certifications, such as CBAP, PMP, ITIL, Six Sigma.\n\u2022 Proven analytical thinking and problem solving capability\n\u2022 Excellent oral and written communication and presentation skills with a business partner orientation\n\u2022 Excellent customer relationship and customer service skills\n\u2022 Proven skills in relationship building\n\u2022 Ability to understand clients needs and how technology contributes to the delivery of a product or services\n\u2022 Strong negotiation and influential skills\n\u2022 Ability to multi-task and meet deadlines in a fast-paced, changing environment. Self-starter with hands-on attitude.\n\u2022 Strong project management and organizational skills including effective delegation techniques, strong issues and risk management experience, and strong intra-team coordination skills\n\u2022 Ability to quickly understand new business processes and to recognize the relevant business questions associated with a business process\n\u2022 Ability to lead and influence various constituencies, including clients, other Business Analysts, and Technical Team members\n\u2022 Experience delivering solutions in a mixed-shore managed service delivery model\n\u2022 Experience in facilitating requirements gathering for complex solutions that involve multiple stakeholders and competing priorities\n\u2022 Experience with all technical components of BI solutions, including data modeling, ETL, Reporting and Analysis, Data Quality, etc.\n\u2022 Understanding of basic types of database structures including 3NF, dimensional, and multi-dimensional models\n\u2022 Ability to do detailed data and systems analysis\n\u2022 Ability to write SQL queries\n\u2022 Experience in testing and validating BI solutions\n\u2022 Experience with Informatica, Cognos, Veeva and/or DataFlux.", "date_new": "2012-04-28 20:25:59", "url": "http://www.amgen.jobs/xml/28261413/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Business Systems Analyst - Field Sales support", "reqid": "15493BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28261413}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15509BR\nJob Posting Title Principal IS Architect (IS Infrastructure Service Manager for External Hosted Services)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The primary responsibility of this position is to provide infrastructure service management responsibilities for Amgen applications that are hosted externally (e.g. SharePoint, External Amgen websites.). This position is the focal point for all infrastructure operational activities related to these external hosted Enterprise applications.\n- Act as an Infrastructure lead for Amgen IS staff that are in the process of engaging an externally hosted environment.\no Document and understand the cost associated in integrating with Amgen account provisioning process ( e.g. IDM, LDAP, Account Federation)\no Identify the cost of additional network connections that are called out ( WAN)\no Understand any inter-independency of the Application Hosting environments (server, database, middleware management)\no Understand how changes are implemented (e.g. change control process)\no Assure appropriate assessments are complete and adequate, including Architectural and Security assessments\n\n- Provide single point of contact and oversight to ensure the following infrastructure items are covered in the contractual agreement:\n- Redundant infrastructure\n- Platform operations management\n- Middleware/database operations management\n- Change & Release management\n- Incident & Problem management\n- Availability, performance and capacity management\n\n- Lay out infrastructure roadmap, strategy and guidelines for how Amgen would engage such external hosted environments (e.g. synergy possibilities of multiple services hosted with one vendor)\n- Standardize solution by developing a checklist or specification, such as providing a standard list of non functional (e.g. infrastructure) requirements.\n- Collaborate with Global Strategic Sourcing to ensure service contract covers appropriate service levels, metrics, requirements, and financial incentives/penalties for infrastructure related services\n- Assist with operational escalations as necessary\n- Work in/with cross functional teams and initiatives\n\nResponsibilities also include driving alignment and compliance with existing and new global processes, and ensuring that external hosting environment for infrastructure services are managed in a consistent and disciplined manner.\n\nThe position will also require an in-depth understanding of the overall infrastructure requirements for external hosting environment, so he/she is effective in working with external vendors and Amgen Infrastructure organizations ( e.g. Data Center facilities personnel, network and storage teams, Identity Management team, and operating system and database teams).\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Master\u2019s Degree in Computer Science, Information Systems, or Business Administration\n\nExtensive domain knowledge\n\n6+ years experience in supporting and managing operations in a globally diverse corporate enterprise environment.\n\nVery strong fundamental knowledge of TCP/IP, DNS, and VPN technology\n\nExtensive understanding and knowledge working as a network engineer in a large enterprise environment\n\nExtensive knowledge in Identity Management support ( e.g. Site Minder, LDAP, AD, Kerberos, Single Sign On and Federation concepts)\n\nGood knowledge of server and database administration to support high availability architecture\n\nThe following certifications are a plus: TCCNA, CCIE, MCSE\n\nAn in-depth understanding of the overall infrastructure requirements for external hosting environment, so that candidate is effective in working with external vendors and Amgen Infrastructure organizations ( e.g. Data Center facilities personnel, network and storage teams, Identity Management team, and operating system and database teams).\n\nKnowledge of IS quality and compliance policies & SOPs\n\nStrong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management.\n\nExcellent data-driven problem solving and analytical skills\n\nGood organizational skills, and ability to concurrently manage multiple assignments.\n\nExperience leading large initiatives in multiple functional areas of a complex organization.\n\nProven experience as part of a high performance team.\n\nUnderstanding of, and experience with, ITIL 3.0 best practices and enterprise change control procedures.", "date_new": "2012-04-28 20:25:01", "url": "http://www.amgen.jobs/xml/28261412/job", "country": "United States", "company": "Amgen", "title": "Principal IS Architect (IS Infrastructure Service Manager for External Hosted Services)", "reqid": "15509BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28261412}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15526BR\nJob Posting Title Human Resources Senior Manager\nCareer Category Human Resources\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful candidate will be a Sr Human Resources Business Partner (Sr HRBP) for one of Amgen\u2019s functional area business units.\n\nThe Sr HRBP will be a strategic partner for client group management teams to help their staff and organizations reach their full potential. This position provides the opportunity to develop solutions to a variety of complex HR problems in support of designated client groups in a fast-changing environment. This Sr HRBP will use consulting skills to help clients achieve business objectives and increase the effectiveness of their organizations. They also will coach clients on a variety of HR and business-related issues to effect change in the organization. Additional responsibilities include staff relations responsibilities, including leadership development, rewards and recognition, talent management, engagement and retention, conducting investigations and making disciplinary recommendations, and the roll out of corporate HR programs.\n\nThis position will be located at Amgen\u2019s corporate headquarters in Thousand Oaks, CA.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree or & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MBA or other Masters degree with emphasis in such areas as organizational development, management, human resources development, physical sciences or equivalent highly desired. Industry knowledge also highly preferred.\n\nMinimum 8 years of progressively complex/strategic HR experience, including organization effectiveness, staff relations, compensation, staff development and recruitment.\n\nDemonstrated ability to understand the clients\u2019 needs and develop both strategic and tactical solutions to tangible business challenges; sound knowledge of applicable employment laws, regulations, and business practices related to the field of Human Resources.\n\nDemonstrated ability to learn and understand multiple therapeutic areas, products, and selling models.\n\nStrong analytical, problem solving, consulting, and project management skills.\n\nStrong communication and interpersonal skills required.\n\nAbility to interact with and influence all levels of staff, management, and executives.\n\nAbility to partner with HR functions.\n\nSome travel is required.", "date_new": "2012-04-28 20:22:41", "url": "http://www.amgen.jobs/xml/28261403/job", "country": "United States", "company": "Amgen", "title": "Human Resources Senior Manager", "reqid": "15526BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28261403}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15381BR\nJob Posting Title Specialist IS Bus Sys Analyst (Web and Collaboration - Sharepoint)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful candidate will establish and maintain a positive business relationship with managers, staff and external business partners that utilize the COE\u2019s services. He or she will demonstrate a thorough ability to obtain understanding of the functional area business models, processes, and priorities, and leverage that knowledge in the delivery of production solutions to meet client automation needs. He or she will participate in and/or facilitate cross-functional team meetings to discuss and optimize business process automation and will present key findings to Information Systems and business management. He or she will coordinate the efforts of other Information Systems groups in the delivery of support for the assigned functional areas.\n\nHe or she will:\n\u2022 Understand business requirements and current process and help find ways to improve using OOTB SharePoint functionality. Help business clients learn to construct complex solutions in SharePoint. Balance finding solutions with maintaining client\u2019s ability to understand and support going forward.\n\u2022 May lead Internal SharePoint Technical Consulting team - Lead a team of SharePoint experts to provide internal \"consulting\" services to business functions across the enterprise\n\u2022 Lead projects involving custom development work for Enterprise Collaboration, Portal, and Extranet platforms\n\u2022 Participate in architecture, strategy and direction for Enterprise Collaboration, Portal, and Extranet platforms\n\u2022 Manage expert SharePoint contract resources hired by the business. Define a stable, realistic, repeatable model for these types of engagements\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor's degree in Computer Science, or Master's degree in Computer Science\n\nExcellent documentation and writing skills are crucial. The ability to develop, document and communicate processes and follow accepted Amgen IS policies and standards is mandatory.\n\nThe ability to identify business patterns used for collaboration and translate the patterns into standardized solutions using SharePoint technologies is a key skill set. Ability to use initiative for proactively engaging clients to help them scope their needs and develop solutions is crucial. Candidates must be able to work independently and provide recommendations on strategies for meeting client needs within the scope of the COE\u2019s service offerings.\n\nHe or she should have the ability to see the big picture and zoom-into specific areas to provide a creative approach to problem solving, innovation and issue resolution. The Candidate should have good interpersonal skills and the ability to communicate and collaborate proactively with others. Candidates should possess a strong ability to learn new technologies, and be able to work in a high pressure, fast paced environment.\n\nExperience with software development processes including source code control, functional and performance testing, and technical documentation, as well as, experience managing an enterprise-class system is highly desired.\n\nPreferred areas of knowledge:\n\u2022 SharePoint 2007 or SharePoint 2010\n\u2022 Microsoft SharePoint development best practices (experience using ASP.NET or C#)\n\u2022 Microsoft Online Services (BPOS/Office365)\n\u2022 Building complex OOTB SharePoint solutions with no development\n\u2022 Web technologies (full stack understanding)\n\u2022 CS fundamentals\n\u2022 Project management; team leadership\n\u2022 Vendor Management\n\u2022 Formalized requirements gathering\n\u2022 Design Specifications\n\u2022 Software Development Methodologies\n\u2022 Unit and Integration Testing", "date_new": "2012-04-27 20:21:50", "url": "http://www.amgen.jobs/xml/28241202/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Bus Sys Analyst (Web and Collaboration - Sharepoint)", "reqid": "15381BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28241202}, {"country_short": "DEU", "city": "Munich", "description": "Auto req 15521BR\nJob Posting Title Praktikant/in Marketing H\u00e4matologie/Onkologie\nCareer Category Marketing\nEmployee Subgroup Co-Op FT Salaried\nCountry (State/Region) Germany\nLocation (City) Munich\nAmgen Job Description Ab sofort f\u00fcr suchen wir f\u00fcr einen Zeitraum von mindestens 6 Monaten einen engagierten und motivierten Studenten oder Absolventen der Pharmazie, Humanbiologie, Biologie, Biochemie, Medizin oder Betriebswirtschaft (bzw. mit \u00e4hnlichem Studiengang) als\n\n\nPraktikant (m/w)\nf\u00fcr den Bereich Marketing H\u00e4matologie/Onkologie\n\n\nSie lernen die vielf\u00e4ltigen Prozesse innerhalb des Bereiches Marketing kennen und unterst\u00fctzen die Produktmanager sowie Marketing-Assistentinnen bei unterschiedlichsten Aufgaben, wie z. B.\n\n\u2022 Ausarbeitung von Informationsmaterialien\n\u2022 Unterst\u00fctzung bei der Organisation von Weiterbildungen\n\u2022 Umsetzung der Au\u00dfendienstkampagnen\n\u2022 Erstellung von Pr\u00e4sentationen/\u00dcbersetzungen\n\u2022 Allgemeinen administrativen Aufgaben\n\u2022 \u00dcbernahme von eigenst\u00e4ndigen Projektaufgaben innerhalb der Marketing Abteilung\nBasic Qualifications \u2022 Studium der Pharmazie, Humanbiologie, Biologie, Biochemie, Medizin - alternativ Betriebswirtschaft (Vordiplom jeweils vorausgesetzt)\n\u2022 Medizinisches Verst\u00e4ndnis erw\u00fcnscht\n\u2022 Gute Kenntnisse im Umgang mit dem PC (MS Office)\n\u2022 Sehr gute Deutsch- und gute Englischkenntnisse - schriftlich wie m\u00fcndlich\n\u2022 Gute Kommunikationsf\u00e4higkeiten\n\u2022 Pro-Aktivit\u00e4t, Kreativit\u00e4t, Teamorientierung und Flexibilit\u00e4t\n\u2022 Zeit f\u00fcr ein 6-monatiges, verg\u00fctetes Praktikum (gerne auch Pflichtpraktikum)\nPreferred Qualifications Sie erhalten hervorragende Einblicke bei dem weltweit gr\u00f6\u00dften Biotechnologie-Unternehmen und die Gelegenheit, Ihre fachlich-professionellen F\u00e4higkeiten sowie auch Ihrer pers\u00f6nlichen und sozialen Kompetenzen weiter zu entwickeln. Unser Arbeitsumfeld ist von Offenheit und Erfolgsorientierung gepr\u00e4gt - der Teamgedanke wird gro\u00df geschrieben.\n\nKonnten wir Ihr Interesse wecken? Dann freuen wir uns auf die \u00dcbermittlung Ihrer aussagef\u00e4higen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse) \u00fcber unser online-Recruitingportal.\nF\u00fcr weitere Informationen zu AMGEN laden wir Sie herzlich auf unsere Homepage unter www.amgen.de ein.\n\nF\u00fcr Fragen vorab steht Ihnen Frau Martina Rech (Staffing Manager) unter der Telefonnummer (089) 14 90 96-11 12 gerne zur Verf\u00fcgung.", "date_new": "2012-04-27 20:21:34", "url": "http://www.amgen.jobs/xml/28241188/job", "country": "Germany", "company": "Amgen", "title": "Praktikant/in Marketing H\u00e4matologie/Onkologie", "reqid": "15521BR", "state": null, "state_short": null, "location": "Munich, DEU", "uid": 28241188}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 15363BR\nJob Posting Title Mgr Maintenance\nCareer Category Maintenance\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Maintenance Manager \u2013 Level 5\nAmgen Dun Laoghaire - Dublin\n\nThis role leads a small group of engineers / technical professionals delivering a technical service requiring the job holder to apply knowledge and experience of engineering principles to a broad variety of assignments. Principally the jobholder will develop technical solutions to complex problems, while managing, coordinating and reviewing the work of others.\n\n\u2022Carry out fault investigation and problem analysis for maintenance related issues, identify alternative solutions, prepare proposals for modifications or improvements and execute/trial as necessary\n\n\u2022Provide input at various project stages to review maintainability \u2013 be involved in new equipment installation and accept handover from project teams to maintenance. Check technical content of handover documentation and ensure PM system is updated.\n\n\u2022Administer control and develop PM System, provide technical input for developing PM\u2019s and for other maintenance aspects of maintenance documentation; assisting with equipment/process fault identification and improvements.\n\n\u2022Administer and control planned maintenance systems ensuring work orders are issued, completed and returned on time, running reports, analysing trends and issuing proactive worksheets.\n\n\u2022Provide technical input into preparation and issue of SOP\u2019s; corrective action tracking; operation and maintenance manuals.\n\n\u2022Assist with preparation and co-ordination of shutdown activities, manage and review activity schedules and produce summary reports\n\n\u2022Conduct area self assessment and implement corrective actions, evaluate new equipment/processes for safety issues related to maintenance functions. Conduct departmental risk assessment in conjunction with the EHS department.\n\n\u2022Participation in \u2018call-out system\u2019 to cover Engineering response (out of normal hours, management of weekend maintenance activities\nBasic Qualifications \u2022Bachelor's degree in Engineering, Science or related field.\n\n\u2022Significant relevant work experience within operations/manufacturing environment\n\n\u2022Direct experience with regulated environments (i.e. cGMP, OSHA, EPA)\n\n\u2022Established expertise in multiple areas of engineering technology.\nPreferred Qualifications \u2022Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.\n\n\u2022Working knowledge of financial analysis tools' and appreciation for project cost development\n\n\u2022Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation.\n\n\u2022Written communication including technical writing.\n\n\u2022Team leadership skills: Management, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-04-27 20:21:28", "url": "http://www.amgen.jobs/xml/28241185/job", "country": "Ireland", "company": "Amgen", "title": "Mgr Maintenance", "reqid": "15363BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 28241185}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15438BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - Dallas, TX\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Texas\nLocation (City) Field Based\nAmgen Job Description Territory:(#17414) Dallas-North, TX - covering - Dallas, Irving, Las Colinas, Plano, Mesquite, McKinney, Richardson, Lewisville\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-27 20:20:57", "url": "http://www.amgen.jobs/xml/28241167/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - Dallas, TX", "reqid": "15438BR", "state": "Texas", "state_short": "TX", "location": "Field Based, TX", "uid": 28241167}, {"country_short": "FRA", "city": "Neuilly-sur-Seine", "description": "Auto req 15485BR\nJob Posting Title Associate Contracts & Pricing\nCareer Category Sales & Marketing Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) France\nLocation (City) Neuilly-sur-Seine\nAmgen Job Description 40000320, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40000320, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40000320, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2012-04-27 20:20:46", "url": "http://www.amgen.jobs/xml/28241160/job", "country": "France", "company": "Amgen", "title": "Associate Contracts & Pricing", "reqid": "15485BR", "state": null, "state_short": null, "location": "Neuilly-sur-Seine, FRA", "uid": 28241160}, {"country_short": "IND", "city": "Mumbai", "description": "Auto req 15167BR\nJob Posting Title Sr Mgr Regulatory Affairs (Supplier Process Owner)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) India\nLocation (City) Mumbai\nAmgen Job Description Group Purpose \u2013 Supplier Management:\n_ Maximizing the value of suppliers\n- Implementation of supplier management strategies\n- On-site supplier site operations (technical)\n\nJob Summary:\n- On site supplier management of key GRAAS Suppliers\n- Site operations oversight\n- Subject matter expertise for regulatory and safety activities\n- Liaise between functions, SPOs and Quality and supplier\n- Day to day monitoring of on site productivity and quality\n\nKey Activities:\nStrategy Development\n- Provide input into strategic design and implementation for processes, systems and supplier organization design\n\nSupplier Start-up and Engagement\n- Provide technical expertise and guidance to suppliers, with minimal supervisions and oversight\n- Troubleshoot technical start up issues, and resolve with supplier management team while in alignment with stakeholder expectations\n- Support training of suppliers\n- Liaise between supplier and functional teams on technical issues\n\nRelationship Management\n- Lead / participate in resolution of technical / business / financial / productivity or site operations issues with suppliers\n\nOperations Management\n- Provide on-site day to day management of overall site operations (i.e. \u2013 scheduling, expenses, status reporting, issue/risk management etc)\n- Provide leadership and direction to supplier management team on a day-to-day basis\n- Provide on site subject matter expertise and guidance to suppliers\n- Provide on site monitoring of completion of work in accordance with service level agreements (SLAs) and contracts, and developing and implementing CAPAs\n- Provides on site knowledge of drug development and commercialization to supplier oversight\n- Provides on site working knowledge of regulatory guidelines, familiarity with US FDA, EMEA regulations, cGCP and other relevant regulatory frameworks to supplier performance\n- Develops supplier teams by leveraging good communication skills, quality principles and ability to mentor\n\nQuality Management Support\n- Review and maintain KCI, KPI, metrics, compliance related documentation, and conduct / complete RCA / CAPA activities\n- Lead / manage on site operational process improvement\nBasic Qualifications - Doctorate degree and 2 years of directly related experience\nOR\n- Master\u2019s degree and 6 years of directly related experience\nOR\n- Bachelor\u2019s degree and 8 years of directly related experience\nOR\n- Associate\u2019s degree and 10 years of directly related experience\nOR\n- High school diploma / GED and 12 years of directly related experience\nPreferred Qualifications - MD, DO, PhD, PharmD\n- 9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical drug development experience (obtained working at a biotech, pharmaceutical or CRO company)\n- Direct experience with either Pharmacovigilance, Regulatory, or Records Management\n- Experience at, or oversight of, drug development suppliers (CROs, central labs, imaging suppliers, etc.)\n- Experience working in a global, matrix organization\n- Knowledge of Quality Management, Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines\n- Extensive project management/project planning experience\n- Proficiency in anticipating and resolving problems\n- Experience writing and presenting clearly on scientific and clinical issues\n- Experience leading teams in a matrix environment\n- Excellent interpersonal, organizational, supervisory skills\n- Professional collaboration and leadership skills", "date_new": "2012-04-26 18:21:18", "url": "http://www.amgen.jobs/xml/28203658/job", "country": "India", "company": "Amgen", "title": "Sr Mgr Regulatory Affairs (Supplier Process Owner)", "reqid": "15167BR", "state": null, "state_short": null, "location": "Mumbai, IND", "uid": 28203658}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15474BR\nJob Posting Title Dir Regulatory Affairs (Global, Biosimilars)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.\n\nJob Summary:\n- Provide global regulatory leadership and support to the Amgen Biosimilars Operating Unit\n- Facilitate product development and global registration of the Amgen biosimilar portfolio by developing and executing regulatory strategies\n- Ensure that regulatory approvals to support clinical trials are acquired and maintained\n- Achieve desired global labeling that are compliant with regulatory requirements\n- Manage effective interactions with regulatory authorities\n\nKey Activities:\nRegulatory Strategy & Filing\n- Provide expertise and leadership in the development, communication, and implementation of approved global regulatory strategies and plans in support of biosimilar goals and product portfolio execution\n- Lead and provide regulatory direction to cross-functional teams\n- Ensure regulatory documents are developed with high quality, delivered in a timely manner, consistent with biosimilars strategies, and compliant with current global regulatory authority requirements\n- Ensure all filings are maintained per regulatory requirements\n- Ensure development and execution of clinical/ non-clinical strategies, including regulatory review, input and advice for study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports, and related regulatory documents required to support product development and registration\n- Ensure development of product labels and core data sheets\n- Identify process needs to meet internal challenges\nRegulatory Interactions\n- Plan, execute and lead agency meetings per regulatory strategy\n- Lead the generation and submission of briefing books to support regulatory interactions\n- Facilitate ad hoc interactions, RTQ responses and meetings\n- Ensure coordinated planned and ad hoc contacts with regulatory authorities on the development and registration of biosimilar products\nRegulatory Intelligence\n- Monitor, assess and implement regional regulatory requirements\n- Review and assess impact of regulatory decisions for competitive products\n- Ensure that biosimilar regulatory intelligence gained by the Biosimilars Regulatory Function is communicated to the Biosimilars Operating Unit, other Amgen functions and partners as appropriate\nBiosimilars Policy\n- Provide subject matter expertise to GRAAS Biosimilars Policy function as required\nCollaboration\n- Ensure that regional regulatory activities are appropriately coordinated with Amgen affiliates\n- Support vendor oversight and management for regulatory and safety operations\n- Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function\n- Represent Biosimilars Regulatory Affairs on committees, as necessary\n- Share insights on biosimilar regulatory requirements with colleagues\nBasic Qualifications - Doctorate degree and 4 years of directly related experience\nOR\n- Master's degree and 8 years of directly related experience\nOR\n- Bachelor's degree and 10 years of directly related experience\nAND\n4 years of direct managerial and /or leadership experience\nPreferred Qualifications - Experience in the biosimilars/ biotechnology industry\n- Experience in interacting with regulatory agencies\n- Regulatory submissions experience\n- Experience interacting with senior regulatory agency representatives\n- RAC\n- Regulatory knowledge of global regulations\n- Familiarity in working with policies, procedures and SOPs\n- Understanding of drug development\n- Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes\n- Regulatory experience with product filings\n- Experience interacting and communicating with senior executives and teams regarding strategic issues to ensure expectations are understood\n- Experience communicating and clearly presenting strategic and business issues\n- Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment\n- Deep knowledge of strategic management models and frameworks\n- Ability to understand and communicate scientific and clinical information\n- Ability to anticipate and prevent potential issues\n- Ability to manage and mentor others\n- Cultural awareness and sensitivity to achieve results across different regions", "date_new": "2012-04-26 18:20:02", "url": "http://www.amgen.jobs/xml/28203630/job", "country": "United States", "company": "Amgen", "title": "Dir Regulatory Affairs (Global, Biosimilars)", "reqid": "15474BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28203630}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15401BR\nJob Posting Title Clinical Data Mgmt Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Data Management Manager will be accountable for CDM study activities and oversight of the CROs and the Functional Service Provider for multiple therapeutic areas including Early Development Oncology. This role is part of a Therapeutic study team located at Amgen's headquarters in Thousand Oaks, CA . The preference is for the person to be located in Thousand Oaks, CA.\n\n\nThe Clinical Data Mgr\u2019s responsibilities include:\n\nCo-ordination and mentoring of lead data managers within assigned projects\n\nLeading CDM activities for assigned study teams\n\nEnsuring clinical projects are executed according to set timelines with quality and consistency\n\nEnsuring that CDM procedures and processes are adhered to\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelors degree in life science, computer science, business administration or related discipline\n\n6+ years work experience in clinical data management in the Pharmaceutical or Biotech arena\n\n3+ years project management and planning experience\n\nExperience in oversight of outside vendors (CRO\u2019s, central labs, imaging vendors, etc.)\n\nExperience working in Medidata Rave 5.x\n\nSolid understanding of clinical data handling procedures related to clinical oncology in solid tumor indications", "date_new": "2012-04-26 18:19:48", "url": "http://www.amgen.jobs/xml/28203622/job", "country": "United States", "company": "Amgen", "title": "Clinical Data Mgmt Mgr", "reqid": "15401BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28203622}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15503BR\nJob Posting Title Contracts & Pricing Director\nCareer Category Sales & Marketing Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Position Responsibilities/Accountabilities\n\n\u2022 Facilitates the development of comprehensive, multi-year U.S. pricing strategies\u2014including list price and contracting\u2014for the relevant brands/business segments; recommends discrete price actions to adjudicate pricing issues as they arise.\n\u2022 Maintains excellent relationships with relevant Business Unit, Finance, Business Law, Global Government Affairs, and Global Payor Planning stakeholders to ensure pricing strategies are aligned with brand goals, consistent with global price guidelines, socially responsible, financially sound, and legally compliant.\n\u2022 Responsible for the implementation and rollout of specific pricing actions supporting the U.S. pricing strategy through superior leadership of the cross-functional Pricing and Contracting Segment Team\u201d.\n\u2022 Accountable for the latest estimate discount rate (LEDR) forecasts for relevant brands, ensuring forecast accuracy and SOX compliance of the forecasting process.\n\u2022 Accountable for government price forecasts for Average Selling Price (ASP), Best Price (BP), and Average Manufacturer Price (AMP) for relevant Amgen and competitor products, ensuring forecast accuracy and reconciling forecasts to actual price submissions.\n\u2022 Leads a team of ~3-4 direct report pricing professionals, establishing standards and norms of conduct for professional behavior; creates a climate in which performance standards are continually raised and staff are developed through regular, specific and actionable coaching.\n\u2022 Closely collaborates with Amgen\u2019s Business Units and Corporate Account Payer Reimbursement Organization to develop Commercial and Medicare Part D contracting strategies. Also leads internal approval process and subsequent roll-out to field management.\nBasic Qualifications \u2022 Doctorate Degree & 4 years of directly related experience OR\n\u2022 Masters Degree & 8 years of directly related experience OR\n\u2022 Bachelor\u2019s Degree & 10 years of directly related experience AND\nPreferred Qualifications \u2022 6 years of direct managerial and/or leadership experience\n\u2022 Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution\n\u2022 Strong oral/written communications skills and interpersonal skills with Senior Management presence\u201d; able to communicate at all organizational levels\n\u2022 Proven ability to manage in a highly fluid, interactive, matrixed environment; demonstrated ability to successfully manage multiple simultaneous, complex projects to completion\n\u2022 Authoritative command of complexity and ambiguity; ability to see the big picture; ability to collect, digest and assemble information to enable relevant business analyses and influence decision-making\n\u2022 Excellent technical skills and fluency with spreadsheet model design and/or software development.\n\u2022 Deep understanding of the U.S. Government and Commercial reimbursement environment.\n\u2022 Previous Managed Markets Contracts and Pricing experience with a large Bio / Pharma company preferably in a leadership role", "date_new": "2012-04-26 18:19:24", "url": "http://www.amgen.jobs/xml/28203613/job", "country": "United States", "company": "Amgen", "title": "Contracts & Pricing Director", "reqid": "15503BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28203613}, {"country_short": "GBR", "city": "Cambridge", "description": "Auto req 14537BR\nJob Posting Title Regulatory Affairs Senior Mgr\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Cambridge\nUxbridge\nAmgen Job Description The purpose of this role is:\n\n\u2022To ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products\n\u2022To ensure regulatory compliance, with a focus on patient safety\n\u2022As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)\n\nThis role is responsible for:\n\n\u2022Advising the GRT on regional considerations in developing strategy\n\u2022Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders\n\u2022 May manage one or more regional leads or support roles\n\nKey Activities:\n\n1.Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.\n2.Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.\n3.Leads development of regional regulatory documents and meetings in accordance with GRT strategy\n4.Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan)\n5.Directs the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.\n6.Manages regional label negotiation activities\n7.With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning\n8.Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives\n9.Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)\n10.Communicates regulatory strategies as appropriate such that expectations are understood.\n11.Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management\n12.Develop predictions for expectations and risks associated with outcomes by regulatory agencies\n13.Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)\n\nKnowledge & Skills:\n\n1.Regulatory knowledge in national regulations\n2.Working with policies, procedures and SOP\u2019s\n3.Experience with national legislation and regulations relating to medicinal products\n4.Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.\n5.Understanding of drug development\nBasic Qualifications - Doctorate degree and 2 years of directly related experience\nOR\n- Master\u2019s degree and 6 years of directly related experience\nOR\n- Bachelor\u2019s degree and 8 years of directly related experience\nOR\n- Associate\u2019s degree and 10 years of directly related experience\nOR\n- High school diploma / GED and 12 years of directly related experience\nPreferred Qualifications \u2022 Experience gained within a biologics organisation\n\u2022 Second degree or further education/qualifications\n\u2022 Project management Expertise", "date_new": "2012-04-26 18:18:54", "url": "http://www.amgen.jobs/xml/28203603/job", "country": "United Kingdom", "company": "Amgen", "title": "Regulatory Affairs Senior Mgr", "reqid": "14537BR", "state": null, "state_short": null, "location": "Cambridge, GBR", "uid": 28203603}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15397BR\nJob Posting Title Exec Dir Compliance\nCareer Category Compliance\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Executive Director Compliance role is responsible for planning, organizing, and directing all activities related to ensuring the R&D organization\u2019s compliance with regulations and requirements specifically managing the R&D audit functions and compliance advice activities.\n\nKey responsibilities for this position include:\n\n\u2022 Conceives and directs audit and compliance strategies designed to ensure acceptability of regulatory applications and compliance of post marketing activities (pharmacovigilance and labeling)\n\u2022 Provides comprehensive assurance that activities regulated by good pharmacovigilance practices (GPvP), good clinical practices (GCP) , and Good Laboratory practices (GLP) are compliant with external regulatory guidelines and internal company policies and procedures.\n\u2022 Ensure Senior Management is informed of all critical compliance issues in a timely manner; aggregate issues on an ongoing, periodic basis\n\u2022 Lead, manage and motivate a team of approximately fifty staff.\n\u2022 Collaborate with the R&D organization to develop best practices and provide guidance as necessary to ensure compliance across teams\n\u2022 Evaluate the need for, and oversight of audits of external investigator sites, vendors, and internal processes including documentation systems and compliance with appropriate regulations\n\u2022 Develops and implements risk management processes used to establish the need for compliance, assign appropriate priority to efforts, and allocate appropriate resources needed to ensure full compliance.\n\u2022 Monitor, evaluate, and manage the resource implications resulting from regulatory inspections and the rapid growth of regulated systems.\n\u2022 Assure effective management of all R&D regulatory authority inspections and advise development teams regarding effective management of clinical site and/or vendor inspections\n\u2022 Identify and follow up on corrective action plans arising from audits involving training as necessary\n\u2022 Engage with leaders in other compliance organizations within Amgen\n\u2022 Contributes to the overall strategy of the Commercialization and R&D Compliance organization.\nBasic Qualifications \u2022 6 years of direct managerial and/or leadership experience, AND\n\u2022 Doctorate degree & 6 years of directly related experience, OR\n\u2022 Master\u2019s degree & 10 years of directly related experience, OR\n\u2022 Bachelor\u2019s degree & 12 years of directly related experience\nPreferred Qualifications \u2022 JD or MBA\n\u2022 10 years experience managing compliance and/or regulatory affairs or legal teams in a major pharmaceutical or biotech company, including GCP and GLP\n\u2022 Excellent working knowledge of US and Global regulations pertaining to GCP, GLP, CFR, ICH, MHRA Pharmacovigilance inspection program.\n\u2022 Knowledge in GMP, pharmacovigilance, healthcare compliance and research compliance desirable\n\u2022 Experience in other related areas of compliance including OIG, GMP\n\u2022 Proven communication skills; teamwork and negotiation skills; ability to work through conflicting situations\n\u2022 Excellent technical writing skills\n\nCompetencies\n\nTo perform the job successfully, an individual should demonstrate the following competencies:\n\n\u2022 High level of organizational skills and flexibility with the ability to prioritize\n\u2022 Ability to integrate company goals and strategies with compliance requirements\n\u2022 Strong knowledge in the areas of medical and regulatory affairs and the drug development process\n\u2022 Strong ability to champion\u201d internal policies for audit internal procedures.\n\u2022 Ability to communicate effectively orally and in writing.\n\u2022 Ability to gather information from multiple sources to understand problems; strong problem solving abilities.\n\u2022 Demonstrated leadership ability.\n\u2022 Ability to maintain confidentiality at all times is required.", "date_new": "2012-04-25 21:11:44", "url": "http://www.amgen.jobs/xml/28183917/job", "country": "United States", "company": "Amgen", "title": "Exec Dir Compliance", "reqid": "15397BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28183917}, {"country_short": "USA", "city": "Cambridge", "description": "Auto req 15355BR\nJob Posting Title Scientist\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Massachusetts\nLocation (City) Cambridge\nAmgen Job Description Amgen is seeking a creative and highly-motivated Scientist to be part of a newly formed Therapeutic Innovation Unit at the Amgen Cambridge Research Center in Cambridge, MA. The Innovation Unit's mission is to carry out broad impact research projects that have the potential to significantly impact human disease outcomes.\n\nIn this role you will use a strong background in molecular and cellular biology and have a working knowledge of genomic and bioinformatics tools.\n\nAdditionally, you will use proven analytical and problem solving skills combined with the drive and scientific curiosity to successfully utilize the latest findings and technologies in our research programs.\n\nIn this role you will work in a collaborative environment and on interdisciplinary teams.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 6 years of scientific  experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of scientific experience\nPreferred Qualifications \u2022 A Ph.D. degree in the life sciences with 3-5 years of postgraduate research experience\n\n\u2022 A well-documented background of scientific expertise in molecular and cell biology. Experience in cell signaling and/or immunology is preferred\n\n\u2022 Experience with shRNA screening and Lentivirus experience is a plus\n\n\u2022 Ability to propose and implement scientific ideas consistent with the strategic needs of the Therapeutic Innovation Group\n\n\u2022 Excellent communication and interpersonal skills as well as the ability to function successfully in a matrixed team environment", "date_new": "2012-04-25 21:10:36", "url": "http://www.amgen.jobs/xml/28183870/job", "country": "United States", "company": "Amgen", "title": "Scientist", "reqid": "15355BR", "state": "Massachusetts", "state_short": "MA", "location": "Cambridge, MA", "uid": 28183870}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 15452BR\nJob Posting Title Senior SAP BASIS Systems Administrator (Java; Portal XI/PI)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nUnited States - Colorado\nLocation (City) Boulder\nThousand Oaks\nAmgen Job Description The Senior SAP BASIS Systems Administrator (Java; Portal XI/PI) (formal Amgen title is Specialist IS Programmer Analyst) can be located at either Amgen's site in Boulder, Colorado, or Amgen's headquarters in Thousand Oaks, CA.\n\nAs part of the Amgen IS Shared Services organization, the Specialist IS Programmer Analyst will: lead the design and oversee development of cross-functional, multi-platform application systems; provide technical and process leadership while partnering with client-facing IS team to drive the tactical delivery of application solutions; integrate systems across Amgen infrastructure and services; set guidelines based on existing SOPs and standards as to the proper use of application development and integration patterns; partner with architects, business analysts, system administrators, information security, project managers and other parts of internal solutions delivery and support teams as well as business partners to implement complex solutions; provide focused consulting services on projects and govern compliance of those projects with architecture standards and roadmaps while ensuring that the design and development teams remain compliant with evolving enterprise standards.\n\nAdditionally, responsibilities include the following:\n\u2022 Identify risks and mitigations with project manager and technical team\n\u2022 Understand scope and high level requirements and lead the solution elaboration and implementation\n\u2022 Guide project team on elaborating significant architecture risks\n\u2022 Participate in requirements solicitation to better understand system requirements\n\u2022 Own System Design Specification (SDS)/System Detailed Design Specification (SDDS), with input and support from an architect and technical team, coordinating SDS/SDDS review and approval\n\u2022 Coordinate implementation activities and issue resolution for system deployment\n\u2022 Own Installation Qualification (IQ) process and documentation, with input and support from technical team, coordinating IQ review, approval and execution\n\u2022 Coordinate technical knowledge transfer with application support for post-go-live support\n\u2022 Occasionally involve in custom/interface development work on projects that require deep technical knowledge and skills (e.g. performance monitoring, early stage prototyping)\n\u2022 Experience in installation, configuration, and maintenance of various SAP systems (ECC/GTS/SRM/BW/SCM/PI/EP/SolMan) in WINDOWS / SQL Server environment\n\u2022 Manage and support multiple SAP landscapes\n\u2022 Assist in the planning, designing and architecture of SAP systems\n\u2022 Maintenance of multi-landscape environments through client copies, system refreshes, and transport management\n\u2022 SAP profile parameter changes, workload analysis, system error analysis and establishment of standard BASIS background jobs, system health checks, and monitoring\n\u2022 Impact analysis of new SAP releases to current system landscape environments\n\u2022 Analysis of system performance, database performance, system health checks and implementation of tuning improvements\n\u2022 Evaluate and apply SAP kernel patches and support packs\n\u2022 Perform system upgrades\n\u2022 Perform client and system copies;\n\u2022 Develop client and landscape strategies and batch scheduling\n\u2022 Troubleshooting of ABAP and Java stacks; Work with SAP in resolving the issues\n\u2022 Java Export and imports\nBasic Qualifications \u2022Doctorate degree\nOR\n\u2022Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Eight or more years of hands-on SAP Basis Administration, with emphasis in configuration, analysis, and troubleshooting in Netweaver 2004 and Netweaver 2004S systems.\n\u2022 Desire to continuously learn and take on new challenges with little oversight\n\u2022 Experience Installing, Configuring, Performance Tuning, Patching and Upgrading SAP NetWeaver (6.40, 7.x)\n\u2022 Ability to troubleshoot complex systems as well as provide root cause analysis\n\u2022 Extensive experience with Windows 2003 and 2008 Server as well as Microsoft SQL Server\n\u2022 Prior ownership of different SAP Usage Types (e.g., ECC, BW, XP/PI, Enterprise Portal, Solution Manager, APO)\n\u2022 Experience performing SAP System Refreshes and System Copies\n\u2022 Knowledge of web technologies, including web and application servers as well as some development experience (e.g., IIS, Apache, Weblogic, HTML, JSP)\n\u2022 Knowledge of SAP Java Transports using CMS, CTS or CTS+\n\u2022 Experience configuring and supporting System Landscape Directory, configuring Data Providers and creating Business Systems and\n\u2022 Familiarity with highly available systems and services (e.g., Load Balancing, Disaster Recovery, Fault Tolerance)\n\u2022 Experience implementing Single Sign-On using Kerberos, SiteMinder or HTTP Headers\n\u2022 Working knowledge of public key encryption using PGP\n\u2022 Prior experience supporting EDI systems (e.g., Gentran Integration Suite, Sterling Integrator, Seeburger)\n\u2022 Excellent written and verbal communication skills; ability to clearly document operating procedures\n\u2022 Prior experience in a rigid change management environment\n\u2022 Familiarity with GxP, Sarbanes Oxley and Validated Computer Systems", "date_new": "2012-04-24 20:54:07", "url": "http://www.amgen.jobs/xml/28152864/job", "country": "United States", "company": "Amgen", "title": "Senior SAP BASIS Systems Administrator (Java; Portal XI/PI)", "reqid": "15452BR", "state": "California", "state_short": "CA", "location": "Boulder, CA", "uid": 28152864}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15391BR\nJob Posting Title Sr Project Mgr - Drug Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Drug Delivery PMO is a function within Operations\u2019 Drug Delivery organization that provides portfolio and project management leadership to advance device business process programs at Amgen and ensures the device development business and governance processes are followed. As part of the Drug Delivery PMO team, the successful candidate will support the Drug Delivery organization to:\n\u2022 Lead complex, cross functional business process projects for maturing the device business across Amgen and ensuring that it meets regulatory requirements. These projects will involve aligning disciplines such as Quality systems, commercialization, clinical trials, regulatory filings and design transfer. Current areas of focus will include integration of the device business process in Amgen\u2019s Quality systems; ensuring that clinical trials management can effectively handle devices and ensuring that Device Design Control regulatory requirements are met through the device business process and Amgen\u2019s systems.\n\u2022 Utilizing Operational Excellence discipline, drive sustainment and continuous improvements in the overall device business to drive efficiency and effectiveness.\n\u2022 Manage the development of best practices for tools and templates required for a device development projects\n\nResponsibilities\nKey responsibilities include, but are not limited to, the following:\n\u2022 Lead multi-disciplinary device business process projects with a clearly articulated scope using standard project management methodology.\n\u2022 Develop statements of work and manage outside consultants to provide subject matter expertise on projects\n\u2022 Lead functional stakeholders in defining scope, risks and schedule to integrate device requirements into current business process and quality systems.\n\u2022 Support the creation and management of a master device business process maturity strategy\n\u2022 Accountable for defining, leading, and delivering results for projects supporting device network goals\n\u2022 Own deliverables throughout project lifecycle, aligning work from a broad set of project stakeholders\n\u2022 Integrate all key activities and project milestones into the master device business process maturity plan\n\u2022 Represent program in routine leadership briefings and stakeholder communications for aspects of assigned initiatives\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor\u2019sDegree in engineering, life-science or business and 8 years of directly related experience\n\nExperience working on medical devices\n\nKnowledge of Amgen\u2019s current commercialization process\n\n7 or more years in Continuous Improvement, Industrial Engineering, Lean Manufacturing, Six Sigma or related functional experience within Quality, Manufacturing, Development, Research or Process Development\n\nCertified or experience in process improvement methodologies such as Six Sigma/DMAIC/DFSS or PDCA\n\nDemonstrated ability to forge and maintain strong relationships with multiple functional areas\n\nStrong leadership skills\n\nAbility to tactfully and effectively negotiate and influence\n\nAbility to communicate and present ideas to all levels of staff and management\n\nBe a team player and self-starter who is capable of growth and increased responsibility\n\nProficient in basic project management methodology and tools\n\nGood analytical problem solving skills\n\nProficiency in MS office suite including Excel, Power Point, and Project", "date_new": "2012-04-24 20:53:48", "url": "http://www.amgen.jobs/xml/28152837/job", "country": "United States", "company": "Amgen", "title": "Sr Project Mgr - Drug Delivery", "reqid": "15391BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28152837}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15356BR\nJob Posting Title Sr Engineer - Drug Process Development\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Provide process development technical support to protein drug product manufacturing at Amgen contracted manufacturing sites including process performance; implementation of process improvement strategies; development of process models.\n\n\u2022 Act as a drug product contract manufacturing technical expert and team leader to provide leadership and solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products.\n\u2022 Provide process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer.\n\u2022 Troubleshoot issues with drug product processing technologies and equipment.\n\u2022 Develop and characterize drug product processes and transfer technology to commercial drug product sites.\n\u2022 Conduct risk assessment for drug product operations and propose / implement appropriate CAPA.\n\u2022 Identify and implement operational opportunities for current and new sterile operations.\n\u2022 Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.\n\u2022 Travel to domestic and international contract manufacturing sites required\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 M.S. in Science or Chemical Engineering and 6 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.\n\u2022 Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability is strongly desired. Excellent written and verbal communication skills.\n\u2022 Project management skills including the ability to manage multiple projects and evaluate project resource requirements.\n\u2022 Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.\n\u2022 Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.", "date_new": "2012-04-24 20:51:14", "url": "http://www.amgen.jobs/xml/28152785/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Drug Process Development", "reqid": "15356BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28152785}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 15454BR\nJob Posting Title Senior SAP BASIS Systems Administrator (Java; Portal XI/PI)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Colorado\nLocation (City) Boulder\nAmgen Job Description The Senior SAP BASIS Systems Administrator (Java; Portal XI/PI) (formal Amgen title is Specialist IS Programmer Analyst) will be located at Amgen's site in Boulder, Colorado.\n\nAs part of the Amgen IS Shared Services organization, the Specialist IS Programmer Analyst will: lead the design and oversee development of cross-functional, multi-platform application systems; provide technical and process leadership while partnering with client-facing IS team to drive the tactical delivery of application solutions; integrate systems across Amgen infrastructure and services; set guidelines based on existing SOPs and standards as to the proper use of application development and integration patterns; partner with architects, business analysts, system administrators, information security, project managers and other parts of internal solutions delivery and support teams as well as business partners to implement complex solutions; provide focused consulting services on projects and govern compliance of those projects with architecture standards and roadmaps while ensuring that the design and development teams remain compliant with evolving enterprise standards.\n\nAdditionally, responsibilities include the following:\n\u2022 Identify risks and mitigations with project manager and technical team\n\u2022 Understand scope and high level requirements and lead the solution elaboration and implementation\n\u2022 Guide project team on elaborating significant architecture risks\n\u2022 Participate in requirements solicitation to better understand system requirements\n\u2022 Own System Design Specification (SDS)/System Detailed Design Specification (SDDS), with input and support from an architect and technical team, coordinating SDS/SDDS review and approval\n\u2022 Coordinate implementation activities and issue resolution for system deployment\n\u2022 Own Installation Qualification (IQ) process and documentation, with input and support from technical team, coordinating IQ review, approval and execution\n\u2022 Coordinate technical knowledge transfer with application support for post-go-live support\n\u2022 Occasionally involve in custom/interface development work on projects that require deep technical knowledge and skills (e.g. performance monitoring, early stage prototyping)\n\u2022 Experience in installation, configuration, and maintenance of various SAP systems (ECC/GTS/SRM/BW/SCM/PI/EP/SolMan) in WINDOWS / SQL Server environment\n\u2022 Manage and support multiple SAP landscapes\n\u2022 Assist in the planning, designing and architecture of SAP systems\n\u2022 Maintenance of multi-landscape environments through client copies, system refreshes, and transport management\n\u2022 SAP profile parameter changes, workload analysis, system error analysis and establishment of standard BASIS background jobs, system health checks, and monitoring\n\u2022 Impact analysis of new SAP releases to current system landscape environments\n\u2022 Analysis of system performance, database performance, system health checks and implementation of tuning improvements\n\u2022 Evaluate and apply SAP kernel patches and support packs\n\u2022 Perform system upgrades\n\u2022 Perform client and system copies;\n\u2022 Develop client and landscape strategies and batch scheduling\n\u2022 Troubleshooting of ABAP and Java stacks; Work with SAP in resolving the issues\n\u2022 Java Export and imports\nBasic Qualifications \u2022Doctorate degree\nOR\n\u2022Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Eight or more years of hands-on SAP Basis Administration, with emphasis in configuration, analysis, and troubleshooting in Netweaver 2004 and Netweaver 2004S systems.\n\u2022 Desire to continuously learn and take on new challenges with little oversight\n\u2022 Experience Installing, Configuring, Performance Tuning, Patching and Upgrading SAP NetWeaver (6.40, 7.x)\n\u2022 Ability to troubleshoot complex systems as well as provide root cause analysis\n\u2022 Extensive experience with Windows 2003 and 2008 Server as well as Microsoft SQL Server\n\u2022 Prior ownership of different SAP Usage Types (e.g., ECC, BW, XP/PI, Enterprise Portal, Solution Manager, APO)\n\u2022 Experience performing SAP System Refreshes and System Copies\n\u2022 Knowledge of web technologies, including web and application servers as well as some development experience (e.g., IIS, Apache, Weblogic, HTML, JSP)\n\u2022 Knowledge of SAP Java Transports using CMS, CTS or CTS+\n\u2022 Experience configuring and supporting System Landscape Directory, configuring Data Providers and creating Business Systems and\n\u2022 Familiarity with highly available systems and services (e.g., Load Balancing, Disaster Recovery, Fault Tolerance)\n\u2022 Experience implementing Single Sign-On using Kerberos, SiteMinder or HTTP Headers\n\u2022 Working knowledge of public key encryption using PGP\n\u2022 Prior experience supporting EDI systems (e.g., Gentran Integration Suite, Sterling Integrator, Seeburger)\n\u2022 Excellent written and verbal communication skills; ability to clearly document operating procedures\n\u2022 Prior experience in a rigid change management environment\n\u2022 Familiarity with GxP, Sarbanes Oxley and Validated Computer Systems", "date_new": "2012-04-24 20:49:46", "url": "http://www.amgen.jobs/xml/28152730/job", "country": "United States", "company": "Amgen", "title": "Senior SAP BASIS Systems Administrator (Java; Portal XI/PI)", "reqid": "15454BR", "state": "Colorado", "state_short": "CO", "location": "Boulder, CO", "uid": 28152730}, {"country_short": "GBR", "city": "Uxbridge", "description": "Auto req 15165BR\nJob Posting Title International Dev Medical Dir\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Uxbridge\nAmgen Job Description Overview:\n\nThis is a newly formed role in the International Bone, Neuroscience & Inflammation TA.\nAMG 785 is a key program for Amgen and reached EoP2 in summer 2011 for the PMO program and is advancing into phase 3 with two phase 3 PMO protocols, currently planned to start enrollment in 2012. Ongoing phase 2 activities for this molecule includes fracture healing programs in hip and tibia fracture. Proof of concept does not yet exist in these indications. It is expected that the IML for AMG 785 partners with the Prolia IML as appropriate, since strategic alignment is required between these two molecules (partnered with UCB and GSK respectively).\n\nKey responsibilities:\n\n\u2022 Implementation and completion of AST\u2019s (Amgen sponsored studies)\n\u2022 Leads development of study protocols for International AST\u2019s; supports and executes international study protocol preparation, filing, review and approval in line with Amgen processes and policies\n\u2022 Ensures that International input is included as appropriate in GSP/GDP and global study protocols and SCD\u2019s\n\u2022 Supports Affiliates in protocol development of Local AST\u2019s and approves Local AST\u2019s prior to IPRC submission (in conjunction with GDO)\n\u2022 Identify/resolve issues related to study design that arise during study execution\n\u2022 Provides interpretation of clinical study data and preparation/authoring of technical sections of clinical study reports, ensure consistency of CSRs for a clinical program\n\u2022 Participates in the development of Global strategies and tactics in close collaboration with the GDL and the International TA Head\n\u2022 Visits selected KOLs and study groups for strategic discussions and protocol development\n\u2022 Reviews International and Local ISS proposals\n\u2022 Partners with the International Brand Directors in the development and execution of the International product(s) lifecycle management plan\n\u2022 Oversees in-sourced/outsourced International medical programs and logistics\n\u2022 Supports regulatory and ethics approvals for Global development studies\n\u2022 Organizes and/or conducts International Advisory Board Meetings/Expert Panels and participates in Investigator Meetings, as appropriate\n\u2022 Member of respective IBT\n\u2022 Provides medical expertise for pipeline products\n\u2022 Provides medical expertise for Health Economy and reimbursement requests\n\u2022 Chairs the International Medical Team (IMT)\nBasic Qualifications \u2022 Medical degree with deep scientific expertise in\nPreferred Qualifications \u2022 Substantial clinical development experience, preferably from a pharmaceutical or possibly well established biotechnology company\n\u2022 Experience with clinical study management and conduct\n\u2022 Broad and formal leadership experience\n\u2022 Commercial acumen, ideally launch experience\n\u2022 Knowledge of pharmaceutical product development, product lifecycle and commercialisation process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs\n\u2022 Therapeutic area knowledge\n\u2022 Network of customer contacts in therapeutic area\n\u2022 Finance and budgeting experience", "date_new": "2012-04-24 20:49:23", "url": "http://www.amgen.jobs/xml/28152716/job", "country": "United Kingdom", "company": "Amgen", "title": "International Dev Medical Dir", "reqid": "15165BR", "state": null, "state_short": null, "location": "Uxbridge, GBR", "uid": 28152716}, {"country_short": "DEU", "city": "Field Based", "description": "Auto req 15382BR\nJob Posting Title Mitarbeiter/in wiss. Au\u00dfendienst H\u00e4m/Onk-Gebiet: Hannover, Celle, L\u00fcneburg..\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Germany\nLocation (City) Field Based\nAmgen Job Description Mitarbeiter/in f\u00fcr den wissenschaftlichen Au\u00dfendienst H\u00e4matologie/Onkologie (XGEVA)\n\nGebiet: Hannover, Celle, L\u00fcneburg, Buxtehude, Stade, Verde, Nienburg\n\nDie Stelle ist zun\u00e4chst befristet f\u00fcr 2 Jahre zu besetzen (Option auf \u00dcbernahme)\n\nAUFGABEN:\n\u2022 Sachkundige und umsichtige Beratung und Betreuung von Meinungsbildnern in Kliniken und Praxen miz dem Ziel, die vereinbarten Umsatzziele im Gebiet zu erreichen\n\u2022 Darstellung des Nutzens unserer Produkte f\u00fcr Patienten und Mediziner auf der Basis wissenschaftlich belegter Daten/Studien\n\u2022 Umsetzung wissenschaftlicher Erkenntnisse in verk\u00e4uferische Resultate\n\u2022 Enge Zusammenarbeit mit den Teamkollegen und den Spezialisten aus Key Account- und Produktmanagement\n\nDer Mitarbeiter berichtet an den regionalen Au\u00dfendienstleiter Hem/Onc Team Nord.\nBasic Qualifications Fachlich:\n\u2022 naturwissenschaftliches Studium w\u00fcnschenswert, evtl. ad\u00e4quate Ausbildung\n\u2022 3 bis 4 Jahre Berufserfahrung als Pharmareferent/Pharmaberater im Spezialau\u00dfendienst\n\u2022 vertriebsorientierte Ausbildung mit Berufserfahrung in kompetitiven M\u00e4rkten und Erfahrung im wissenschaftlichen Au\u00dfendienst\n\u2022 Kenntnisse und Berufserfahrung im Bereich Knochenstoffwechsel sowie H\u00e4matologie/Onkologie/Urologie\n\u2022 gute Englischkenntnisse\n\nPers\u00f6nlich:\n\u2022 Marketing- und vertriebsorientierte Denk- und Arbeitsweise\n\u2022 sicheres und gewandtes Auftreten, \u00dcberzeugungsf\u00e4higkeit, Akzeptanz bei anspruchsvollen Gespr\u00e4chspartnern\n\u2022 ausgepr\u00e4gte Kommunikations- und Teamf\u00e4higkeit\n\u2022 Reisebereitschaft und Pioniergeist\nPreferred Qualifications Wir freuen uns auf Ihre Online-Bewerbung.\n\nBei R\u00fcckfragen kontaktieren Sie gerne Martina Rech (Staffing Manager) unter Tel. (089) 14 90 96-1112.", "date_new": "2012-04-24 20:49:11", "url": "http://www.amgen.jobs/xml/28152707/job", "country": "Germany", "company": "Amgen", "title": "Mitarbeiter/in wiss. Au\u00dfendienst H\u00e4m/Onk-Gebiet: Hannover, Celle, L\u00fcneburg..", "reqid": "15382BR", "state": null, "state_short": null, "location": "Field Based, DEU", "uid": 28152707}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15445BR\nJob Posting Title Sr Counsel - Healthcare Regulatory\nCareer Category Law/Legal\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This experienced and knowledgeable attorney will provide strategic and practical advice to internal clients. This attorney will primarily provide legal support for Global Development, including Scientific Affairs and Global Health Economics, Global Regulatory Affairs and Safety, and Worldwide Compliance and Business Ethics. This individual will work directly with clients, providing counsel on a wide variety of drug development legal and regulatory issues. Experience dealing with healthcare/fraud and abuse issues and FDA regulatory issues is especially pertinent and experience with Privacy laws, clinical and consultant contracts, and/or products liability is also very relevant. This individual will work independently and in teams to identify and advise on business and regulatory issues with important legal implications. They will interact with clients and Law Department colleagues in different countries and across departments.\nBasic Qualifications JD degree from an accredited law school and admission to practice law required\n\n4 or more years of experience practicing law\nPreferred Qualifications 6 or more years of practice at a national law firm, corporate law department, or a combination of both\n\nExperience working with the FDA and the laws and regulations relating to the discovery, development, approval, sales & marketing (including the federal and state anti-kickback laws) of biotechnology/pharmaceutical products\n\nExperience in a large law firm, biopharmaceutical company or major government agency\n\nExcellent interpersonal skills\n\nAbility to handle, prioritize and follow through on diverse issues on a timely basis\nSelf-starter\n\nResourceful and able to participate in highly collaborative, cross-functional team-oriented environment\n\nAbility to meet demanding deadlines\n\nStrong research and writing skills\n\nManage multi-dimensional projects in fast paced environment\n\nComputer adept", "date_new": "2012-04-21 18:47:48", "url": "http://www.amgen.jobs/xml/28060958/job", "country": "United States", "company": "Amgen", "title": "Sr Counsel - Healthcare Regulatory", "reqid": "15445BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28060958}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15419BR\nJob Posting Title Business Performance Sr Mgr (R & D)\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role will be Research and Development focused but will also support other functional areas as well. The Sr. Manager of Business Performance will respond to project requests from executives and supervise / execute work with high quality results. In doing so s/he will structure the issues and analyses, manage the work, and prepare and present findings. This role will also support business functions by identifying opportunities and risks and developing the strategies to address them. The Manager of Business Performance will be responsible for developing approaches to improve productivity and implement comprehensive change strategies to transform an organization and enable it to adapt to business challenges. This role will interact with a wide range of leadership and staff inside and outside of Amgen (consultants).\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Doctorate or Masters in business, science, finance and/or technology\n\u2022 5+ years experience in biotechnology /pharmaceutical\n\u2022 Experience at a top tier Management Consulting Firm\n\u2022 Strong presence with Senior Executives including ability to communicate effectively on a prepared and ad-hoc basis\n\u2022  Strong quantitative and qualitative analytic skills, specifically financial analysis with an emphasis on valuation\n\u2022  Certification in lean and / or Six Sigma\n\u2022 Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution\n\u2022 Strong leadership skills with a demonstrated ability to influence different styles\n\u2022 Proven experience as a member of a high performing team", "date_new": "2012-04-20 18:41:04", "url": "http://www.amgen.jobs/xml/28035846/job", "country": "United States", "company": "Amgen", "title": "Business Performance Sr Mgr (R & D)", "reqid": "15419BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28035846}, {"country_short": "MEX", "city": "Field Based", "description": "Auto req 15415BR\nJob Posting Title Regional Medical Liaison\nEmployee Subgroup Salaried FT\nCountry (State/Region) Mexico\nLocation (City) Field Based\nMexico City\nAmgen Job Description 40001026, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40001026, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40001026, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2012-04-20 18:40:25", "url": "http://www.amgen.jobs/xml/28035828/job", "country": "Mexico", "company": "Amgen", "title": "Regional Medical Liaison", "reqid": "15415BR", "state": null, "state_short": null, "location": "Field Based, MEX", "uid": 28035828}, {"country_short": "RUS", "city": "Field Based", "description": "Auto req 15414BR\nJob Posting Title ??????????????????? ????????????? (??????)\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Russia\nLocation (City) Field Based\nAmgen Job Description ??????????? ???????????:\n\u2022 ??? ???????????? ???????????? ?????? ??????? ???: ??????????? ? ????????? ?????????? ???????? ? ???????????? ? ?????????????? ???????????, ???????????????? ??????????? ?? ?????????.\n\u2022 ???????????? ? ???????????????? ?????????????? ?????????? ???????? ? ???????????? ? ?????????????? ??????????? ????????.\n\u2022 ?????????? ???????-???????????????? ??????????? ? ???????????? ????????????? ?????????? ????????. ??????? ?????????? ????? ??????????? ?? ???????????? ?????.\n\u2022 ??????????? ? ???????? ????????? ? ????????????? ????????????? ??????? ? ????????????? ?????????????. ????? ? ???????????? ????????? ? ?????????????? ????????????? ??????? ? ????????????? ?????????????. ???????????? ???? ??????? ? ???????? \u2013 ?? ????? 30 ? ??????. ?????????? ???? ?? ??? ?? ?????????? ??????? ??????????????? ????????????? ???????????????? ????????????? ? ?????? ???????? ? ???????? ???? ? ?????????? ? ??????????? ? ????????????? ??????.\n\u2022 ?????????? ??????????? ??????????? ??????????????? ? ???????? ?? ???????????????? ????? ? ??????????????? ???????, ????????? ????? ? ????????????? ?????????? ?? ????????? ? ?? ???? ?????? ????????, ?????????? ?????????? ??????????? ?????.\n\u2022 ??????????? ?????????? ? ??????????? ???????-???????????????? ?????????? ? ????????????? ?????????? ????????, ???? ?????????? ? ?????? ??????????? ? ??????????????.\n\u2022 ??????? ? ????????????? ???????????? ????????? ? ????????? ?????? ???????.\n\u2022 ??????????? ? ?????????? ???????? ??????????? (??????, ???????????, ????????, ???????????, ???????? ? ?. ?.) ? ????????, ??????? ? ???????? ??????????? ???????? ??????? ????????????? ?????.\n\u2022 ?????? ? ???????? ???????? ?????? ? ?????????: ?????????????? ?????? ??????, ??????????? ? ?? ????????, ???????? ???????? ?????????? ???????????. ??????? ?????????? ?? ???????????? ?????.\n\u2022 ??????? ? ?????????? ????????? ? ????????????? ??????????? (???????????). ??????????? ?????????? ???? ???????????.\n\u2022 ?????????? ????????? ????????????????? ??????. ??????? ? ????????? ? ????????? ??????.\nBasic Qualifications \u2022 ??????????? - ?????? ? ??????? ???????? ?/??? ???????.\n\u2022 ????????? ???? ? ???????????????? ??????? ?? 2-? ???.\n\u2022 ?????? ???????????, ???????, ?????????, ???????????.\n\u2022 ????????? ?? ?????????? ????????????? ?????? ???????????.\n\u2022 ?????? ?? ???????????? ?????????? \u2013 ??????? ???????????? MS Office for Windows, Microsoft PowerPoint Presentation .\n\u2022 ??????? ????????????? ????????????? ? ???????????? ?????? ???????? ??????????.\n\u2022 ???????????? ???? ?? ????? 1 ????.", "date_new": "2012-04-19 20:56:05", "url": "http://www.amgen.jobs/xml/28013713/job", "country": "Russia", "company": "Amgen", "title": "??????????????????? ????????????? (??????)", "reqid": "15414BR", "state": null, "state_short": null, "location": "Field Based, RUS", "uid": 28013713}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15406BR\nJob Posting Title Business Analysis & Info Sr Mgr, Oncology\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description BAI Senior Manager, Primary and Secondary Market Research, and Competitive Intelligence\n\nThis Business Analysis & Information (BAI) team member is assigned to support an Amgen Therapeutics global franchise. This person will:\n\n\u2022 Create productive relationships with assigned Global marketing teams to define business priorities and orchestrate the collection, analysis, and communication of market research and strategic insights\n\u2022 Apply structured problem solving approaches to key competitive questions, working with BAI colleagues to integrate results from other BAI disciplines, e.g. competitive intelligence, forecasting and inline products\n\u2022 Independently plan, design, and conduct multiple simultaneous complex projects in support of the global strategic plans, proactively defining the critical path, anticipating potential obstacles, and recommending actions to keep projects on track\n\u2022 Manage external vendors and consultants to enable effective project execution\n\u2022 Provide competitive business insights based on project results with actionable recommendations to brand/business stakeholders\n\u2022 Ensure that both routine and ad-hoc projects meet service-level expectations for quality, timeliness, and budget\n\u2022 Some travel required to supervise market research and attend key meetings, etc.\n\u2022 The candidate should expect to make a 18-24 month commitment to this role.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nPreferred Qualifications \u2022 Advanced degree (MS/MBA/PhD) preferred.\n\u2022 7-10 years experience across all aspects of primary market research and secondary data (both inline and pipeline)in the biopharma or related healthcare industries.\n\u2022 Experience within the oncology therapeutic areas, with established networks (suppliers, thought leaders, practitioners, etc.), understanding of the evolving market dynamics, and familiarity with key competitors (activities, strategic intent, views, assumptions)\n\u2022 Excellent oral, written and presentation skills\n\u2022 Strong project management skills.\n\u2022 Demonstrated analytical skills with a client service orientation.\n\u2022 Ability to work collaboratively in a team environment.", "date_new": "2012-04-19 20:55:53", "url": "http://www.amgen.jobs/xml/28013707/job", "country": "United States", "company": "Amgen", "title": "Business Analysis & Info Sr Mgr, Oncology", "reqid": "15406BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28013707}, {"country_short": "FRA", "city": "Neuilly-sur-Seine", "description": "Auto req 15393BR\nJob Posting Title Admin Coordinator\nCareer Category Administrative\nEmployee Subgroup Salaried FT\nCountry (State/Region) France\nLocation (City) Neuilly-sur-Seine\nAmgen Job Description Chez Amgen, notre vocation est d\u2019\u00eatre la meilleure entreprise pharmaceutique de biotechnologie, en utilisant la science et l\u2019innovation afin d\u2019am\u00e9liorer significativement la vie des patients atteints de pathologies lourdes et invalidantes.\nEntreprise dynamique n\u00e9e dans les ann\u00e9es 1980 aux Etats-Unis, Amgen a su se d\u00e9velopper et s\u2019implanter dans le monde entier. En moins de vingt ans, notre filiale fran\u00e7aise a vu cro\u00eetre parall\u00e8lement son chiffre d\u2019affaires et ses effectifs. Aujourd\u2019hui, ses 350 collaborateurs sont fiers de son statut de premi\u00e8re filiale Europ\u00e9enne et de l\u2019image dont elle b\u00e9n\u00e9ficie dans le monde de l\u2019industrie pharmaceutique.\nChez Amgen, vous travaillerez avec des collaborateurs performants et des leaders exemplaires, dans une culture impr\u00e9gn\u00e9e par nos valeurs. Notre entreprise a de belles r\u00e9ussites \u00e0 son actif, une r\u00e9elle volont\u00e9 de d\u00e9veloppement et un avenir prometteur.\n\nLes Missions\nRattach\u00e9(e) au Directeur de la Business Unit N\u00e9phrologie & Rhumatologie, vous travaillerez en \u00e9troite collaboration avec le Directeur des Ventes et le Responsable Marketing.\n\n- Assistanat des Ventes\nVous assurez la coordination logistique de diff\u00e9rents types d\u2019\u00e9v\u00e8nements (congr\u00e8s, formation, mi-cycle\u2026) en collaboration avec les \u00e9quipes respectives.\nVous \u00eates l\u2019interlocuteur privil\u00e9gi\u00e9 des Attach\u00e9s Scientifiques pour toutes demandes ad\u2019hoc (proc\u00e9dures, mat\u00e9riel promotionnel\u2026)\nVous \u00e9laborez les calendriers, les plannings et les agendas en fonction des sp\u00e9cificit\u00e9s de chaque d\u00e9partement\n\n- Assistanat Marketing\nVous assistez le chef de produit et la responsable marketing dans la pr\u00e9paration des campagnes : gestion des relations avec l\u2019agence, gestion des impressions, suivi des livraisons, suivi des validations de relecture des documents promotionnels.\nVous g\u00e9rez les contrats et suivez le paiement des orateurs en collaboration avec le d\u00e9partement \u00ab Compliance \u00bb.\n\n\n\n- Support BU\nVous cr\u00e9ez et suivez les demandes d\u2019achat\nVous organisez les r\u00e9unions internes & externes (webex, confcall, ordre du jour & compte rendu)\nBasic Qualifications Votre Profil\nDe niveau Bac/BTS en Gestion/Secr\u00e9tariat commercial, vous justifiez de pr\u00e9f\u00e9rence d'une premi\u00e8re exp\u00e9rience de minimum 3 \u00e0 5 ans dans un service Marketing / Communication / Vente dans un environnement dynamique.\nVous ma\u00eetrisez les outils informatiques, la connaissance de SAP\u00a9 est un plus.\nOutre l'autonomie, la grande rigueur et la gestion des priorit\u00e9s dont vous faites preuve dans votre travail quotidien, votre efficacit\u00e9, votre flexibilit\u00e9 et l'esprit d'\u00e9quipe qui vous anime feront de vous un interlocuteur privil\u00e9gi\u00e9 au sein d'une \u00e9quipe dynamique.\nPreferred Qualifications Si vous \u00eates en situation de handicap, n\u2019h\u00e9sitez pas \u00e0 informer votre interlocuteur des Ressources Humaines de toute adaptation ou outil n\u00e9cessaire au bon d\u00e9roulement de l\u2019entretien.", "date_new": "2012-04-19 20:55:49", "url": "http://www.amgen.jobs/xml/28013700/job", "country": "France", "company": "Amgen", "title": "Admin Coordinator", "reqid": "15393BR", "state": null, "state_short": null, "location": "Neuilly-sur-Seine, FRA", "uid": 28013700}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15426BR\nJob Posting Title Medical Writing Mgr\nCareer Category Medical Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen is seeking a Medical Writing Manager for their Scientific Affairs Cardio/Renal area. This is a full-time, Thousand Oaks, CA corporate office-based position. Consider joining a team that communicates the results of Amgen's research to the scientific community and embraces Amgen's aspiration to be the world's best human therapeutics company. As key members of North American Medical Teams, Amgen's Scientific Affairs medical writers work closely with authors to develop manuscripts and review articles for peer-reviewed clinical journals as well as abstracts, posters, and slide presentations for scientific congresses.\nIn addition to providing strategic input to product publication teams and scientific congress planning teams, Scientific Affairs writers liaise with medical leads, biostatisticians, safety experts, and health economists as well as external opinion leaders, clinical investigators, and journal editors.\n\nAdditional responsibilities may include the following:\n\u2022Preparing or editing documents for submission to external regulatory agencies\n\u2022Preparing or editing internal documents requiring robust scientific summaries\n\u2022Writing, rewriting, performing QC checks, or editing materials for product dossiers\n\u2022Conducting literature searches, reviewing pertinent literature, and preparing summaries or abstracts, as required\n\u2022Attending scientific congresses and writing daily and post-meeting summaries\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022Doctorate degree\n\u2022Previous medical writing experience in a biotech or pharmaceutical company, or previous postdoctoral research in the cardio/renal area\n\u2022Experience analyzing and communicating scientific data in peer-reviewed journal publications and in abstracts and presentations at scientific congresses\n\u2022Proficient in pertinent software (eg, MS Office, EndNote, Adobe Illustrator)\n\u2022Knowledge of publication guidelines and best practices\n\u2022Superb written and verbal communication skills\n\u2022Experience working independently under limited supervision\n\u2022Ability to apply project management skills to advance numerous projects simultaneously\n\u2022Ability to work in a matrixed team environment\n\u2022Ability to lead and/or facilitate effective team meetings", "date_new": "2012-04-19 20:55:47", "url": "http://www.amgen.jobs/xml/28013697/job", "country": "United States", "company": "Amgen", "title": "Medical Writing Mgr", "reqid": "15426BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28013697}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 15370BR\nJob Posting Title Regional Medical Liaison\nCareer Category Sales & Marketing Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nField Based\nAmgen Job Description Key Activities\n\n- Supports Head Regional Medical Liason (RML)/local Therapeutic Area (TA) Leader in developing local territory R&D tactics\n- Identifies, develops and maintains collaborative relationships with current and future Key Opinion Leaders (KOLs), scientific experts, cooperative study groups and study sites\n- Develops and implements local KOL Plans, in line with local and international KOL strategy\n- Creates end execute engagement plans\n- Implements and disseminates high quality medical and scientific educational programs; gives clinical and scientific presentations at sites / hospitals\n- Identifies new research opportunities, implements and follows up on ISSs and other scientific activities, provides input to the design of local observational research\n- Works with development field operations to ensure prioritization of site selection, and support feasibility across assigned territories\n- Supports ASTs on site with scientific presentations/discussions to create enthusiasm for the scientific program, understand trial/referral networks and identify enrollment barriers, participates in investigator meetings according to approved investigator strategy\n- Represents Amgen Medical department in the territory\n- Ensures society engagement: RML support of international and regional congresses\n- Develops required qualitative and quantitative reports; collates competitor information\n- Ensures conduct of work in line with compliance regulations\n- Delivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments)\n\nReports (at a minimum) to:\nLocal Head RML or local TA Lead\n\nResponsible for:\n- Execution of RML Plan Of Actions\n- Scientific relationships in a set territory\n- KOL profiles, plans and reports\n- Engagement plans\n- Protocol proposals and other study documents for local ISSs\n- Territory input for feasibility and site selection\n- Scientific study site support for ASTs\n- Educational programs to change medical practice\n- Scientific presentations to physicians and hospital departments\n- Field feedback: scientific trends, ongoing studies, CI\n- RML activity tracking\n\nPLEASE NOTE: An Amgen year contract is offered for this position\nBasic Qualifications - Medical or scientific education or experience from similar positions\n- Minimum 3 years of experience in industry, or a related scientific field in academia\n- Experience in sales force, affiliate Medical Department or Clinical Development\n- Willingness to travel; possesses valid driver\u2019s license\n- Experience with clinical study management and conduct\n- Scientific expertise in the therapeutic area\n- Knowledge of commercialization and business practices\n- Knowledge of regulatory affairs, drug safety, legal and compliance environment\n- Network of customer contacts\n- Medical / scientific research experience\n- Fluency in English and Dutch language is required for this role\nPreferred Qualifications - Advanced degree (e.g. PhD , MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training", "date_new": "2012-04-19 20:55:12", "url": "http://www.amgen.jobs/xml/28013663/job", "country": "Netherlands", "company": "Amgen", "title": "Regional Medical Liaison", "reqid": "15370BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 28013663}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15384BR\nJob Posting Title Biostatistical Programming Mgr\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Manager Statistical Programming will work in Amgen's Global Safety & Independent Biostatistics (GSIB) organization Programming team in the Cardiac-renal and General Medicine Therapeutic area\n\n\u2022 Function as product lead programmer on one or more programs of clinical trials across phases I \u2013 IV and observational research studies:\no Lead a programming team in Global Safety & Independent Biostatistics (GSIB) for safety-related programming activities on multiple products, define roles and responsibilities of the programming team members, ensure the analysis and presentation of clinical trial safety data are accurate and complete according to agreed resource and timeline plans;\no Provide programming support to proactive safety surveillance and signal detection based on clinical trial safety data for the covered products;\no Contribute to key safety-related updates - Development Safety Update Reports (DSUR), Risk Management Plan (RMP), Investigational Brochure (IB), and Periodic Safety Update Reports (PSUR), by providing programming support on clinical trial safety data processing and table/figure/listing(TFL) generation and validation;\no Plan and support Data Review Team (DRT)-related programming activities and processes at study or protocol level;\no Adhere to Amgen Policies, Standards of Process (SOPs) and other standards for all programming activities in the covered products;\no Participate in statistical programming process and system audits by Amgen Global Compliance Auditing (GCA) and external bodies, and respond to audit questions and findings.\n\u2022 Provide technical leadership, supervision and technical solutions to programming issues within the product team;\n\u2022 Ensure best programming practice through leadership of programming process improvement initiatives;\n\u2022 Lead and develop technical programming and process improvement initiatives within the product team;\n\u2022 Represent the product programming function and, as required, participate in multidisciplinary project team meetings;\n\u2022 Write, review and approve analysis dataset specifications within product team;\n\u2022 Write, test and validate software programs (including utilities and toolbox) to produce analysis datasets and TFLs for deliverables;\n\u2022 Lead or participate in the development of Amgen Policies, SOPs and other controlled document development;\n\u2022 Participate in the recruitment of programming staff within GSIB, support and mentor junior programmers, manage and develop programming staff or consultants;\n\u2022 Contribute to process improvement and operational efficiency of Global Biomedical Data Sciences (GBDS) and Global Biostatistic Science (GBS);\n\u2022 Collaborate closely with GSIB Biostatisticians, other product leads within GBDS and other functional teams;\n\u2022 Promote and communicate awareness of the role and function of GSIB and communicate to business partners and colleagues.\nBasic Qualifications Minimum 6 years relevant career experience in the pharmaceutical or biotechnology industry, with at least a BS degree in Statistics, Life Science, Computer Science, Mathematics, or other relevant scientific subjects\n(directly related experience should include the management of people and/or experience of leading project teams, drug development programs and/or directing the allocation of programming resources)\nKnowledge:\n\u2022 Biostatistical programming using the SAS System version 9.1.3 or higher;\n\u2022 Understanding of computer operating systems, including UNIX preferred;\n\u2022 Project planning and management;\n\u2022 Drug development process & operations, and drug safety analysis & reporting;\n\u2022 Experience of working within a global team.\nPreferred Qualifications \u2022 Minimum 6 years relevant career experience in the pharmaceutical or biotechnology industry, with at least a BS degree in Statistics, Life Science, Computer Science, Mathematics, or other relevant scientific subjects;\n\u2022 Knowledge of biostatistical programming within drug development industry, knowledge of drug development process and operation, and drug safety analysis and reporting;\n\u2022 Project management skills - ability to plan and manage projects, to allocate team work on complex tasks , to lead a project successfully from programming set-up to completion, and deliver according to agreed timelines;\n\u2022 Communication skills - the ability to communicate effectively within a team and across functions.", "date_new": "2012-04-19 20:55:12", "url": "http://www.amgen.jobs/xml/28013661/job", "country": "United States", "company": "Amgen", "title": "Biostatistical Programming Mgr", "reqid": "15384BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28013661}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15192BR\nJob Posting Title Global Safety Sr Mgr\nCareer Category Safety\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description To focus on device-related safety activities for one or more programs. To be subject matter expert in Amgen Global Safety for activities related to drug delivery device and combination product safety; establishment and execution of procedures and best practices related to device/combination product development and commercialization with respect to safety. To interface as device safety expert across multiple Amgen functional areas including Therapeutic Area Safety, Global Development, Safety Operations, Device Regulatory, Device Quality, and Drug Delivery Division.\n\nJob Summary:\nThe Global Safety Scientist \u2013 Device, will conduct activities related to device safety by providing technical expertise and support to the Global Safety Officer (GSO) and Global Safety Team (GST) for product-associated drug delivery devices. Working under the supervision of the CMC Safety Executive Director and product GSO, will be responsible for device-product combination safety-related evaluations and deliverables for assigned products, worldwide.\n\nKey Activities:\n?Work closely with the GSO and fully participate in GST activities related to device safety\n?Support GSO and GST in specific device development safety activities and clinical interpretation of device associated safety data\n?Contribute to the establishment of critical procedures and best practices related to device/combination product development and commercialization with respect to safety\n?Provide content support for device/combination product evaluation activities including MDR assessments, signal detection, quality monitoring and hazard evaluations, and risk management\n?For assigned products, serve as the device safety representative at selected internal meetings with collaborating Departments\n\nKnowledge and Skills\n?Clinical device safety and pharmacovigilance\n?Knowledge of clinical trials and device development\n?Knowledge of Quality Management Systems, global safety reporting requirements, and risk management for medical devices\n?Knowledge of therapeutic adra patient populations in relatin to drug-device combination products\n?Familiarity with signal recognition and safety evaluation techniques\n?Knowledge of global safety requirements for worldwide pharmacovigilance, especially as related to medical devices\n?Excellent interpersonal and teamwork skills\n?Microsoft Suite \u2013 Outlook, Word, Excel, PowerPoint\n?Critical scientific thinking and problem solving\n?Attention to detail\n?Organizationally savvy in a matrix environment\n?Time management skills\n?Communication skills: presentation and medical writing\n?Issue and conflict resolution\nBasic Qualifications ?Doctorate degree and 2 years of directly related experience\nOR\n?Master\u2019s degree and 6 years of directly related experience\nOR\n?Bachelor\u2019s degree and 8 years of directly related experience\nOR\n\u2022Associate\u2019s degree and 10 years of directly related experience\nOR\n\u2022High school diploma / GED and 12 years of directly related experience\nPreferred Qualifications ?Drug safety, biotech/pharmaceutical or regulatory agency experience (drug delivery/combination product experience)\n\n?Advanced scientific degree (Ph.D. or Pharm. D.) or MD or DO degree from an accredited medical school; or background in medical device development, engineering, clinical or pharmaceutical industry experience\n\nIf non-physician:\n?Demonstrated scientific training\nOR\n?Clinical experience in activities relevant to utilization of medical devidces, especially as related to drug delivery\n\nIf physician:\n?Completion of an accredited medical or surgical residency\nOR\n?Clinical experience in either an accredited academic setting or private practice (including hospital based) setting", "date_new": "2012-04-19 20:54:33", "url": "http://www.amgen.jobs/xml/28013635/job", "country": "United States", "company": "Amgen", "title": "Global Safety Sr Mgr", "reqid": "15192BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28013635}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15418BR\nJob Posting Title Scientist (Cell Sciences & Technology)\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Cell Science and Technology department is recruiting a Scientist (PhD.) level researcher within the cell line development and engineering functional area. The successful candidate will become a key member of a team focused upon the development of production cell lines for Amgen's large molecule biotherapeutic pipeline.\n\nThe successful candidate will help direct lab personnel in both cell line and technology development programs. This team member will work towards the continued development of new, cutting-edge technologies to enhance outcomes and improve current scientific understanding, directed towards improving production cell line development and performance; with yield, speed, and efficiency in mind.\n\nThe Scientist will enhance and improve established platform approaches and utilize solid problem solving skills as well as out-of-the-box thinking to deliver technology improvements.\nBasic Qualifications - Doctorate degree (or finalizing PhD by July 2012)\nOR\n- Master\u2019s degree & 6 years of scientific  experience\nOR\n- Bachelor\u2019s degree & 8 years of scientific experience\nPreferred Qualifications - Ph.D. in molecular / cell biology or associated life science, combined with experience related to or directly applicable to bioprocess development and cell line generation.\n- Strong molecular biology skills are essential together with expertise in mammalian cell culture, in particular stable cell line generation and clone screening.\n- Expertise in transcriptomics or similar \u2018omics\u2019 technologies and/or current gene knockout technologies highly advantageous.\n- Proven interdisciplinary project management skills\n- A track record in resolving and overcoming issues associated with the cell line development process and associated technologies\n- Recognized in the scientific community through a record of publications and/or patents\n- Previous experience in the biotechnology area related to bioprocess and cell line development\n- Solid scientific understanding of cell line development and associated technologies\n- Strong mentoring capabilities, data driven decision-making and project management skills to help drive the team towards new performance levels.\n- Demonstrated independence, innovation and a strong track record of success", "date_new": "2012-04-19 20:53:40", "url": "http://www.amgen.jobs/xml/28013402/job", "country": "United States", "company": "Amgen", "title": "Scientist (Cell Sciences & Technology)", "reqid": "15418BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28013402}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15369BR\nJob Posting Title Sr Scientist (Cell Sciences)\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Seeking a highly motivated and independent individual that will lead a team responsible for the development, optimization, scale-up and transfer of mammalian cell culture processes to support early and late stage pipeline projects.\n\nLead the overall strategy in the planning, design and execution of experiments that successfully meet project timelines and goals. Need to be very hands-on with bioprocess operation and adept in resolving equipment issues.\n\nWork cross-functionally with various groups such as analytical science, purification, pilot plant, and process engineering to leverage resource and support to efficiently and effectively deliver on project milestones.\n\nAuthor development reports, regulatory filings, and scientific publications. Champion and implement continual improvements to the cell culture platform process.\n\nExplore, develop, and implement new cutting-edge cell culture technology that can significantly improve development efficiency, process productivity, and reduce cost.\n\nAct as a scientific resource for the department and for junior members of the group. Ability to initiate, influence, and lead new scientific projects with clear scope to successful completion. Keep up-to-date with the current trends of technology and abreast of scientific publications.\nBasic Qualifications - Doctorate degree & 2 years of scientific experience\nOR\n- Master\u2019s degree & 8 years of scientific  experience\nOR\n- Bachelor\u2019s degree & 10 years of scientific experience\nPreferred Qualifications - Ph.D. in chemical engineering, biochemical engineering, bioengineering or biochemistry\n- 3+ years experience post Ph.D. in a bioprocess development industrial environment\n- Knowledge of license applications and the drug development process\n- Familiar with all aspects of cell culture process development including clone screening, bioreactor optimization, medium development, scale-up and process transfer\n- Need to have worked with small-scale bioreactor models, single-use bioreactors, disposables, high-throughput technology, and had experience supporting GMP manufacturing and troubleshooting large-scale production\n- Deep understanding of cell biology, metabolism, product quality attribute effect is strongly desired\n- Routine use of statistical modeling and analysis of experimental data is required. Knowledge of VBA for Excel is desired.\n- Managerial experience of progressively increased scope\n- Strong project management and interpersonal skills", "date_new": "2012-04-18 18:41:30", "url": "http://www.amgen.jobs/xml/27978714/job", "country": "United States", "company": "Amgen", "title": "Sr Scientist (Cell Sciences)", "reqid": "15369BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27978714}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15380BR\nJob Posting Title Clinical Research Medical Director - Nephrology\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Research Medical Director is responsible for:\n\n- Supporting the development, execution and communication of the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Supporting the development of key scientific external relationships with opinion leaders\n- Participating and providing clinical input into safety and regulatory interactions\n\nKey Activities:\n\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Interpret clinical trial data\n- Participate in safety assessments\n- Participate in interactions with regulatory agencies\n- Author CSRs, publications and regulatory submissions\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL\n- Identify new clinical research opportunities\n- Support in-licensing and out-licensing activities and partner relationships\n- Support product lifecycle management for new indications as directed by Global Development Leader\n- Provide clinical content input to:\n- Regulatory interactions and documents\n- Safety interactions and documents\n- Materials to be used in Scientific Affairs\n- Materials to be used by the Commercial Organization\nBasic Qualifications - MD\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\nPreferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent\n- Experience in Nephrology\n- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\n- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n- prior clinical research in Nephrology\n\nKnowledge\n\n- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Sound scientific and clinical judgment\n- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- Demonstrated ability as a medical expert in a complex matrix environment\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-04-18 18:41:01", "url": "http://www.amgen.jobs/xml/27978706/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Director - Nephrology", "reqid": "15380BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27978706}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15249BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Norhtern Indiana\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Indiana\nLocation (City) Field Based\nAmgen Job Description Territory - #34511 Norhtern Indiana\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-17 20:12:46", "url": "http://www.amgen.jobs/xml/27953387/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Norhtern Indiana", "reqid": "15249BR", "state": "Indiana", "state_short": "IN", "location": "Field Based, IN", "uid": 27953387}, {"country_short": "DNK", "city": "Copenhagen", "description": "Auto req 14588BR\nJob Posting Title Administrativ Coordinator\nCareer Category Administrative\nEmployee Subgroup Salaried FT\nCountry (State/Region) Denmark\nLocation (City) Copenhagen\nAmgen Job Description For our Danish office in Hellerup, we are looking to fill a vacancy for the position as Administrative Coordinator supporting the Country Director and their teams.\nKey Activities:\n\u2022Initiating/facilitating/participating in cross-functional team meetings\n\u2022independently coordinating web-interface meetings\n\u2022Developing slide presentations.\n\u2022Assisting with special projects as requested by the Directors and others within group.\n\u2022 Maintain distribution, contact and personnel lists\n\u2022 Coordinate mailings and courier/deliveries\n\u2022 Coordinate functional processes such as invoicing and payments in SAP\n\u2022 Manage the administrative aspects of relationships with outside experts and vendors\n\u2022 Participate in department project teams\n\u2022 Provide backup support to additional department ACs\n\u2022 Update and maintain all dues, memberships, subscriptions etc.\n\nThis role will leverage an experienced AC who enjoys working in a fast-paced environment, and can ensure timely coordination of the Country Director and Sr. Managers below listed administrative needs. You will also manage individual and team calendars (Outlook), and coordinate local and international meetings such as arrange travel, prepare agendas and have an overall responsibility.\nBasic Qualifications Prefered qualifications:\n\u2022 5 years of experience in an administrative support role supporting large teams at different levels\n\u2022 Advanced computer system knowledge, previous experience with SAP and SharePoint is a plus\n\u2022Experience providing administrative support to remote staff\n\u2022Outstanding organizational and interpersonal skills\n\u2022Ability to work in a fast-paced ,deadline- driven environment\n\u2022Discretion in dealing with proprietary information\nPreferred Qualifications This role will require the employee to be flexible, take initiative and work well independently as well as in teams. This role will proactively anticipate needs, communicate expectations, disseminate and compile information.\nWe are also looking for an individual who is detail-oriented, able to work on multiple projects simultaneously and organize and prioritize workflow. You will be required to be able to handle sensitive and confidential information with diplomacy and discretion.\n\nAnother important skill you must have in order to be successful in this role is to be able to effectively communicate, both orally and in writing both in Danish and English. You will also demonstrate a service-oriented approach to all activities, a willingness to learn new approaches and adapt to change, and will lead by example in promoting teamwork.\n\nWhat we offer you:\nWe can offer you a full time, permanent position in a creative, challenging and international environment with a broad range of work duties and responsibilities.\nAs a part of Amgen International you get training within our international training and development program.\n\nWe are looking for a person that can start working as soon as possible. The position is based in our office in Hellerup, Denmark.\n\nFor more information about the position, contact Eleonore Hassila, HR Department on +46 8 695 11 00 or eleonore.hassila@amgen.com.\n\nTo apply for this position go to www.amgen.com/careers and search for Requisition number 14588BR, no later than May 11th.", "date_new": "2012-04-17 20:12:44", "url": "http://www.amgen.jobs/xml/27953384/job", "country": "Denmark", "company": "Amgen", "title": "Administrativ Coordinator", "reqid": "14588BR", "state": null, "state_short": null, "location": "Copenhagen, DNK", "uid": 27953384}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15148BR\nJob Posting Title Sr Mgr Biostatistics\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis\n\u2022Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications\n\u2022Complete statistical analysis of multiple studies/projects\n\u2022Hire, manage and develop statistical staff\n\u2022Contribute to resource and budget planning\n\u2022Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)\n\u2022Be familiar with statistical policy and strategy at Amgen\n\u2022Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field\n\u2022Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen\n\u2022Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents\n\u2022Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings\n\u2022May lead and/or participate in change / process improvement initiatives\n\u2022May participate in external activities (e.g. Industry, academic)\nBasic Qualifications .Doctorate degree & 2 years of directly related experience\nOR\n.Master\u2019s degree & 6 years of directly related experience\nOR\n.Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nAND\n.2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry,\nwith Bachelor\u2019s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer\nScience, Mathematics, Life Sciences, or other relavent scientific subject\nStrong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines\nStrong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues\nDisplays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes\nTrack record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results\nTakes steps to ensure the ongoing technical development", "date_new": "2012-04-17 20:12:41", "url": "http://www.amgen.jobs/xml/27953376/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Biostatistics", "reqid": "15148BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27953376}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15282BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Southern Arizona\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Arizona\nLocation (City) Field Based\nAmgen Job Description Territory - #36213 Southern Arizona\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-17 20:10:46", "url": "http://www.amgen.jobs/xml/27953273/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Southern Arizona", "reqid": "15282BR", "state": "Arizona", "state_short": "AZ", "location": "Field Based, AZ", "uid": 27953273}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15256BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Houston NE, TX\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Texas\nLocation (City) Field Based\nAmgen Job Description Territory #35113 - Houston NE, TX\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-17 20:10:23", "url": "http://www.amgen.jobs/xml/27953256/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Houston NE, TX", "reqid": "15256BR", "state": "Texas", "state_short": "TX", "location": "Field Based, TX", "uid": 27953256}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15281BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Nothern Arizona\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Arizona\nLocation (City) Field Based\nAmgen Job Description Territory - #36212 Nothern Arizona\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-17 20:09:05", "url": "http://www.amgen.jobs/xml/27953149/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Nothern Arizona", "reqid": "15281BR", "state": "Arizona", "state_short": "AZ", "location": "Field Based, AZ", "uid": 27953149}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15291BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Tacoma, WA - Alaska\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Alaska\nUnited States - Washington\nLocation (City) Field Based\nAmgen Job Description Territory - #36513 Tacoma, WA - Alaska\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-17 20:08:59", "url": "http://www.amgen.jobs/xml/27953140/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Tacoma, WA - Alaska", "reqid": "15291BR", "state": "Alaska", "state_short": "AK", "location": "Field Based, AK", "uid": 27953140}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14527BR\nJob Posting Title Corporate Communications Director, Global Commercial Operations\nCareer Category Corporate Services\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Corporate Communications Director - Global Commercial Operations (GCO) is responsible for developing and executing internal communications strategies and plans that drive staff awareness of and engagement with the business goals, strategies and performance of the GCO organization and Amgen. This individual will also provide communications counsel and tactical support around organizational change and key business initiatives. S/he will work directly with the executive vice president of GCO and members of his leadership team in this high impact role.\n\nThe GCO function encompasses Amgen\u2019s marketing, sales and commercial operations around the world, including the United States, Europe, Asia, Latin America and emerging markets.\n\nReporting to the Executive Director, Internal & Executive Communications, this individual will work with colleagues in Global Communications to develop communications strategies, tactics and messages that will be leveraged across functions and geographies.\n\nResponsibilities Include:\n\u2022 Work directly with the executive vice president of GCO to address his internal communications needs. Provide counsel and develop content for his face-to-face meetings, presentations, panel discussions, webcasts, videos, town halls, intranet news articles, electronic discussion forums, blogs, emails, and voicemails\n\u2022 Develop communications strategies and plans that help GCO teams effectively, consistently, and ethically communicate to their key stakeholders across geographies; flawlessly execute on those plans and deliver measurable results\n\u2022 Serve as the Global Communications representative on internal project teams focused on continuous improvement efforts or evolving business developments\n\u2022 Work in partnership with key, cross-site/cross-function internal and external communication professionals to ensure awareness of key company and Global Commercial Operations initiatives, milestones and news\n\u2022 Measure the results of communications tactics and plans and adapt future plans for continuous improvement.\n\u2022 Some travel may be required\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications \u2022 Top-performing communications professional with demonstrated expertise in corporate communications in the biotechnology / pharmaceutical industry\n\u2022 Results-driven self-starter with the ability to influence others\n\u2022 Experience developing communications strategies and tactics for a sales & marketing function and a proven ability to help senior executives communicate in a clear and compelling manner to engage and influence staff\n\u2022 Internal/external communications leadership for transformational organizational changes\n\u2022 Ability to work on complex and sensitive information, manager a number of programs and projects simultaneously, and deliver and excel under tight deadlines\n\u2022 Understanding of the regulations and environment regarding sales & marketing activities in the biotechnology/pharmaceutical industry\n\u2022 Excellent writing/presentation skills\n\u2022 Excels in highly-matrixed environments\n\u2022 Demonstrated ability to build consensus among diverse leaders and manage sensitive situations\n\u2022 Active listening skills and ability to quickly and effectively incorporate feedback", "date_new": "2012-04-17 20:08:58", "url": "http://www.amgen.jobs/xml/27953139/job", "country": "United States", "company": "Amgen", "title": "Corporate Communications Director, Global Commercial Operations", "reqid": "14527BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27953139}, {"country_short": "SVK", "city": "Bratislava", "description": "Auto req 15358BR\nJob Posting Title Regulatory Affairs Sr Mgr\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) Slovak Republic\nLocation (City) Bratislava\nAmgen Job Description Being the primary point of contact for regulatory authority (ies) in large country.\nObtaining and maintaining local product and pharmaceutical company licenses.\nSenior contact point for any regulatory advice for commercial and medical projects within country/sub-region.\nTranslates global and international business plans to local regulatory and quality objectives\nRepresenting Compliance and Regulatory on the management team of a small/medium country\nEnsuring that local processes, strategies and initiatives are aligned with regulatory requirements defined by Amgen International and Global groups.\nOverseeing the affiliate compliance framework to comply with Local Code & legislation & Amgen Policies and procedures\nIdentifying the need for country specific compliance procedures and overseeing their development and implementation\nProviding senior level regulatory expertise into International regulatory affairs group.\nBasic Qualifications Qualifications\nDegree in scientific discipline\nAdvanced degree or MBA advantageous\nFluency in local language plus English\n\u00a0\nExperience\nSignificant directly related experience in regulatory and compliance areas\nRegulatory expertise in national, MRP, centralised and biotechnology products\nKnowledge of quality systems\nLine management experience\nBuilding relationships with regulatory authorities\nDefining and implementing policies, procedures and SOP\u2019s\nWorking with country senior management teams\n\nKnowledge\nExpert knowledge of national legislation and regulations relating to medicinal products\nIn-depth knowledge about the registration procedures in Europe (Centralised, Mutual recognition and Decentralised) for MAA, variations, extensions and renewals.\nKnowledge about the technical requirements for registration of biotechnology products.", "date_new": "2012-04-17 20:08:54", "url": "http://www.amgen.jobs/xml/27953131/job", "country": "Slovak Republic", "company": "Amgen", "title": "Regulatory Affairs Sr Mgr", "reqid": "15358BR", "state": null, "state_short": null, "location": "Bratislava, SVK", "uid": 27953131}, {"country_short": "PRT", "city": "Lisbon", "description": "Auto req 15368BR\nJob Posting Title Regional Medical Liaison (Temporary)\nCareer Category Medical Services\nEmployee Subgroup Salaried FT\nCountry (State/Region) Portugal\nLocation (City) Lisbon\nAmgen Job Description Due to a maternity leave, we are urgently looking to hire an RML for the nephrology therapeutic area, with a temporary contract. The person will report to the Medical Development Senior Manager, office based in Lisbon.\n\nThe purpose of this role is:\nTo maximize Amgen\u2019s value propositions to create value for patients through medical and scientific projects, services and expertise, with key scientific customers (according to Iinternational R&D strategies) within Nephrology therapuetic area\nTo implement scientific programs in local territories in collaboration with District Sales Manager and Development Field Operations\n\nThe candidate's main responsibilities will be:\nExecution of RML POA\nScientific relationships in a set territory\nKOL profiles, plans and reports\nProtocol proposals and other study documents for local ISSs\nTerritory input for feasibility and site selection\nScientific study site support for ASTs\nEducational programs to change medical practice\nScientific presentations to physicians and hospital departments\nField feedback: scientific trends, ongoing studies, CI\nRML activity tracking\n\n\nKey activities:\nSupports Head RML/local Therapeutic area Leader in developing local territory R&D tactics\nIdentifies, develops and maintains collaborative relationships with current and future KOLs, scientific experts, cooperative study groups and study sites\nDevelops and implements local KOL Plans, in line with local and international KOL strategy\nCreates end execute COER engagement plans\nImplements and disseminates high quality medical and scientific educational programs; gives clinical and scientific presentations at sites / hospitals\nIdentifies new research opportunities, implements and follows up on ISSs and other scientific activities, provides input to the design of local observational research\nWorks with development field operations to ensure prioritization of site selection, and support feasibility across assigned territories\nSupports ASTs on site with scientific presentations/discussions to create enthusiasm for the scientific program, understand trial/referral networks and identify enrollment barriers, participates in investigator meetings according to approved investigator strategy\nRepresents Amgen Medical department in the territory\nEnsures society engagement: RML support of international and regional congresses\nDevelops required qualitative and quantitative reports; collates competitor information\nEnsures conduct of work in line with compliance regulations\nDelivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments)\nBasic Qualifications Minimum of 3 years of experience in industry, or a related scientific field in academia, including at least 1 year in a similar position.\nExperience in sales force, affiliate Medical Department or Clinical Development\nWillingness to travel; possesses valid driver\u2019s license\nExperience with clinical study management and conduct\nScientific expertise in the therapeutic area\n\nNative Portuguese and intermediate level of English\nPreferred Qualifications Knowledge of commercialization and business practices\nKnowledge of regulatory affairs, drug safety, legal and compliance environment\nNetwork of customer contacts\nMedical / scientific research experience", "date_new": "2012-04-17 20:08:44", "url": "http://www.amgen.jobs/xml/27953111/job", "country": "Portugal", "company": "Amgen", "title": "Regional Medical Liaison (Temporary)", "reqid": "15368BR", "state": null, "state_short": null, "location": "Lisbon, PRT", "uid": 27953111}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15251BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Central Illinois\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Illinois\nLocation (City) Field Based\nAmgen Job Description Territory #34513 - Central Illinois\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-17 20:07:56", "url": "http://www.amgen.jobs/xml/27953087/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Central Illinois", "reqid": "15251BR", "state": "Illinois", "state_short": "IL", "location": "Field Based, IL", "uid": 27953087}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15331BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Naperville, IL\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Illinois\nLocation (City) Field Based\nAmgen Job Description Territory #34112 Naperville, IL\n\nAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.  As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of sales experience OR Associate\u2019s degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience\nPreferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelor's degree in Life Sciences or Business Administration  Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact", "date_new": "2012-04-17 20:07:51", "url": "http://www.amgen.jobs/xml/27953082/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Naperville, IL", "reqid": "15331BR", "state": "Illinois", "state_short": "IL", "location": "Field Based, IL", "uid": 27953082}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15089BR\nJob Posting Title Principal IS Architect (Enterprise IS Technology Services Principal Design Engineer) - Networking\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\n\nThe Principal Design Engineer for Enterprise IS Technology Services Design Engineering (EISTS) is responsible for the development, delivery, and life cycle of Amgen IS Infrastructure technologies in networking, firewalls, switches, circuits, VPN, telephony, and all related areas. As a multi-disciplinary expert, the Principal Design Engineer must provide Engineering direction across the organization in their areas and relationships to it from other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle.\n\nJob Responsibilities\n\n\u2022 Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas.\n\n\u2022 Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners.\n\n\u2022 Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS.\n\n\u2022 Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans.\n\n\u2022 Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency.\n\n\u2022 Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks.\n\n\u2022 Lead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Master\u2019s degree\n\u2022 Bachelor\u2019s Degree in Information Systems, Computer Science, or Electronics\n\u2022 10 + years experience working within Information Systems\n\u2022 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus.\n\u2022 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with all facets of network technologies and all related systems including experience implementing and administrating common TCP/IP-based services, including DNS, DHCP, HTTP, FTP, SSH, SMTP, etc.\n\u2022 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus.\n\u2022 5+ years biotechnology or pharmaceutical experience are a plus.\n\u2022 Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments.\n\u2022 The ability to function in multiple roles based on project demands.\n\u2022 Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines.\n\u2022 Excellent oral, written and interpersonal communication skills.\n\u2022 Experience with a range of IT service, architecture, engineering, and design frameworks and languages, including UML and/or BPMN a plus.\n\n\u2022 This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices.\n\u2022 Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes.\n\u2022 This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services", "date_new": "2012-04-16 20:54:23", "url": "http://www.amgen.jobs/xml/27929900/job", "country": "United States", "company": "Amgen", "title": "Principal IS Architect (Enterprise IS Technology Services Principal Design Engineer) - Networking", "reqid": "15089BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27929900}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15338BR\nJob Posting Title Medical Writing Mgr\nCareer Category Medical Services\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, the world's largest biotech company, discovers, develops, and delivers innovative human therapeutics to treat grievous illnesses, such as kidney failure, cancer, rheumatoid arthritis, psoriasis, and osteoporosis.\nHeadquartered in Southern California, Amgen is consistently rated as one of the best places to work and offers competitive compensation and terrific opportunities for the development of its employees.\n\nAmgen is seeking a Medical Writing Manager for their Scientific Affairs Metabolic Bone area. This is a full-time, Thousand Oaks, CA corporate office-based position. Consider joining a team that communicates the results of Amgen's research to the scientific community and embraces Amgen's aspiration to be the world's best human therapeutics company. As key members of North American Medical Teams, Amgen's Scientific Affairs medical writers work closely with authors to develop manuscripts and review articles for peer-reviewed clinical journals as well as abstracts, posters, and slide presentations for scientific congresses.\nIn addition to providing strategic input to product publication teams and scientific congress planning teams, Scientific Affairs writers liaise with medical leads, biostatisticians, safety experts, and health economists as well as external opinion leaders, clinical investigators, and journal editors.\n\nAdditional responsibilities may include the following:\n\u2022Preparing or editing documents for submission to external regulatory agencies\n\u2022Preparing or editing internal documents requiring robust scientific summaries\n\u2022Writing, rewriting, performing QC checks, or editing materials for product dossiers\n\u2022Conducting literature searches, reviewing pertinent literature, and preparing summaries or abstracts, as required\n\u2022Attending scientific congresses and writing daily and post-meeting summaries\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022Doctorate degree\n\u2022Previous medical writing experience in a biotech or pharmaceutical company, or previous postdoctoral research in bone biology or osteoporosis\n\u2022Experience analyzing and communicating scientific data in peer-reviewed journal publications and in abstracts and presentations at scientific congresses\n\u2022Proficient in pertinent software (eg, MS Office, EndNote, Adobe Illustrator)\n\u2022Knowledge of publication guidelines and best practices\n\u2022Superb written and verbal communication skills\n\u2022Experience working independently under limited supervision\n\u2022Ability to apply project management skills to advance numerous projects simultaneously\n\u2022Ability to work in a matrixed team environment", "date_new": "2012-04-16 20:53:28", "url": "http://www.amgen.jobs/xml/27929884/job", "country": "United States", "company": "Amgen", "title": "Medical Writing Mgr", "reqid": "15338BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27929884}, {"country_short": "CZE", "city": "Field Based", "description": "Auto req 15357BR\nJob Posting Title Sr Biopharmaceutical Rep\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Czech Republic\nLocation (City) Field Based\nAmgen Job Description Maximizes sales of Amgen\u2019s products in territory\nAchieves sales targets\nDelivers key messages\nCollaborates with manager to implement agreed POA in line with marketing strategy\nIdentifies and establishes high quality customer relationships and internal collaboration\nKnows in-depth knowledge of the product(s), market , stakeholders and competitors\nWorks within agreed budgets\n\nCollaborates with manager to develop and implement territory POA and key account plans . Achieve POA\nEvaluates progress vs. plan monthly and agrees to course corrections with manager\nContributes to Cluster/Territory Teams Collaborates (Medical Affairs/Key Account Manager, etc.) to agree on key account plan objectives/responsibilities\nEngages with peers and District Manager to learn best practices\nDemonstrates an understanding of industry and healthcare trends, of how retail practices, clinics and hospitals operate.\nIdentify and gather competitive information\nFollows through on customer commitments and requests in a timely fashion\nReports customer activity in the CRM system and ensures customer profiles are kept up-to-date\nDemonstrates an understanding of Amgen Performance 4 selling platform to satisfy customer and Amgen needs\nOperates within the agreed expense budget aligned with POA priorities\nSeeks advise and assistance to organize activities\nContinuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs. Drives own development\nBasic Qualifications Minimum 3 to 5 years of experience in the pharmaceutical industry in a sales-related job\nBasic knowledge of and experience in a hospital environment (not for specialist Sales Reps)\nSome experience with computer systems (CRM databases and MS Office)\nFluency in local language, both in oral and written communication\nRelevant local legal qualification", "date_new": "2012-04-16 20:53:14", "url": "http://www.amgen.jobs/xml/27929881/job", "country": "Czech Republic", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "15357BR", "state": null, "state_short": null, "location": "Field Based, CZE", "uid": 27929881}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15092BR\nJob Posting Title Project Manager - Device Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Project Manager will report into the Program Management Office within the Drug Delivery Organization. This role will lead cross-functional teams from multiple Amgen sites, and external partners, to develop innovative drug delivery devices that are integrated with biologics to create combination drug/device products.\n\nPosition Responsibilities\n\u2022 Perform project management at a high level of professionalism.\n\u2022 Lead projects that utilize internal and external personnel, contract firms, and partners utilizing structured, systematic methodologies to meet objectives.\n\u2022 Follow Amgen\u2019s governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents.\n\u2022 Provide advanced knowledge of schedule management techniques and use of Microsoft Project to create and maintain detailed integrated schedule.\n\u2022 Negotiate and resolve personnel or project conflicts and drive consensus among team members to accomplish project and business goals.\n\u2022 Provide leadership to core team members and provide meaningful feedback to functional leaders regarding team member\u2019s performance and ability to perform assigned tasks.\n\u2022 Foster continuous improvement in the organization\u2019s ability to execute programs and projects, from initiation through launch\n\u2022 Manage program resources to meet business objectives.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022Degree in engineering or related life sciences.\n\u2022 4+ years as a project manager leading cross-functional program teams.\n\u2022 Successful track record of developing commercially viable medical devices/pharmaceutical products from concept through to commercialization.\n\u2022 Deep understanding of and experience with disciplined product development processes (phase/gate product development method).\n\u2022Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes.\n\u2022 Successful experience working with contract development firms and contract manufacturers.\n\u2022 Strong oral and written communications skills; strong interpersonal skills; demonstrated time management and decision making skills required.\n\u2022 Advanced proficiency with Microsoft Project; experienced in creating complex schedules with logical relationships between successor and predecessor tasks.\n\u2022 Experienced in performing critical path analysis.\n\u2022 History as a project manager on FDA-approved 510(k) or PMA-approved medical device that was successfully commercialized.\n\u2022 Experienced with planning and composing documents for FDA submissions.\n\u2022 Experienced in creating and maintaining a Design History File.\n\u2022 Experienced within a CE-marked manufacturer.\n\u2022 Proven ability to manage in a highly fluid, matrix environment.\n\u2022 Experienced with managing programs with annual budgets exceeding $5M.\n\u2022 The ideal candidate will have experience from the medical device industry that includes developing patient use devices.\n\u2022 Certification in Project Management highly desired.", "date_new": "2012-04-14 06:56:35", "url": "http://www.amgen.jobs/xml/27897908/job", "country": "United States", "company": "Amgen", "title": "Project Manager - Device Delivery", "reqid": "15092BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27897908}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15164BR\nJob Posting Title Sr Associate IS Programmer Analyst (Technical Lead / Lead Programmer)\nCareer Category Information Systems\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description As part of IS Enterprise Application Services organization, the Sr Associate IS Programmer Analyst will lead the design and oversee development of cross-functional, multi-platform application systems. Provide technical and process leadership while partnering with client-facing IS team to drive the tactical delivery of application solutions. Integrate systems across Amgen landscape and services. Lead technical aspects of application evaluations. Sets guidelines based on existing SOPs and standards as to the proper use of application development and integration patterns. Partner with architects, business analysts, system administrators, information security, project managers and other parts of internal solutions delivery and support teams as well as business partners to implement complex solutions. Ensure that the company's computing systems are capable of delivering both the basic functionality as well as all non-functional requirements (e.g. performance, scalability, fault tolerance, disaster recovery). Provide focused consulting services on projects and govern compliance of those projects with architecture standards and roadmaps while ensuring that the design and development teams remain compliant with evolving enterprise standards.\n\nResponsibilities:\n\u2022 Evaluate Product/COTS/Technology in partnership with Solution Architecture\n\u2022 Lead the Integration and Implementation of new Software Solutions that spans various Amgen systems and infrastructure\n\u2022 Plan phase/iteration goal and activities with project manager and technical team\n\u2022 Identify risks and mitigations with project manager and technical team\n\u2022 Understand scope and high level requirements and lead the solution elaboration and implementation\n\u2022 Guide project team on elaborating significant architecture risks\n\u2022 Participate in requirements solicitation to better understand system requirements\n\u2022 Own System Design Specification (SDS)/System Detailed Design Specification (SDDS), with input and support from an architect and technical team, coordinating SDS/SDDS review and approval\n\u2022 Identify technical resource/skills needed (Infrastructure, BizTalk, Informatica, Java, .NET, SQL, etc) and work with project manager on resourcing\n\u2022 Recruit, onboard, assign required SOP/training to contract developers\n\u2022 Identify administration/support skills needed (e.g. Server administrator, DB administrator, SSO administrator, Network/Firewall/VPN administrator) and work with project manager on resourcing\n\u2022 Coordinate development tasks (design, unit test, code, source control) and issue resolution among developers\n\u2022 Coordinate implementation activities and issue resolution for system deployment\n\u2022 Own Installation Qualification (IQ) process and documentation, with input and support from technical team, coordinating IQ review, approval and execution\n\u2022 Coordinate technical knowledge transfer with application support for post-go-live support\n\u2022 Occasionally involve in custom/interface development work on projects that require deep technical knowledge and skills (e.g. performance monitoring, early stage prototyping)\nBasic Qualifications - Master\u2019s degree\nOR\n- Bachelor\u2019s degree & 2 years of directly related experience\nOR\n- Associate\u2019s degree & 6 years of directly related experience\nOR\n- High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications Bachelor\u2019s degree in Engineering, Information Systems or Computer Science\n5+ year\u2019s information technologies industry\nExperience with RUP or Agile software development methodologies\nStrong communication and presentation skills\nExperience leading a team of developers\nExperience with Microsoft Project or similar project management tools\nExperience working in a FDA regulated industry such as a pharmaceutical or biotech company\nUnified Modeling Language (UML) design skills\nObject-oriented programming (J2EE, Asp.NET, C#) skills\nWeb user interface and Web Services application development skills\nRelational Database or SQL development skills", "date_new": "2012-04-14 06:56:18", "url": "http://www.amgen.jobs/xml/27897902/job", "country": "United States", "company": "Amgen", "title": "Sr Associate IS Programmer Analyst (Technical Lead / Lead Programmer)", "reqid": "15164BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27897902}, {"country_short": "IRL", "city": "Field Based", "description": "Auto req 14626BR\nJob Posting Title Regional Medical Liaison\nCareer Category Sales\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Field Based\nAmgen Job Description This position is a Regional Medical Liaison (RML) field-based position for the Bone Therapeutic Area in Ireland covering Maternity Leave for a 9-month period.\n\nThe RML will interact with key opinion leaders/healthcare professionals to communicate and advance the scientific platform, as aligned with Amgen's corporate goals, objectives and affiliate medical plans and provide feedback based on those field interactions. The RML will foster relationships with key healthcare professionals including key registrars and nurses. The RML is an integral position in assuring accuracy in communication of our science and products across the medical community.\n\nThe RML will communicate complex cutting edge, scientific information and research concepts to healthcare professionals and support Amgen sponsored research.\n\nThe RML will represent Amgen medical department in the fiels within the Bone Therapeuticc Area in compliance with local and Amgen regulatory standards.\nBasic Qualifications Medical or scientific education with a minimum 3 years experience in similar positions or related jobs such as Medical Communications, Nurse Advisor, CRA or Medical Liaison.\nPreferred Qualifications Advanced degree (e.g. PhD, MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training.\n\nExperience:\n- Working in the bone field\n- Setting up and running research studies in a hosspital environment\n- Knowledge of regulatory affairs, drug safety, legal and compliance environment (IPHA OR ABPI)\n- Network of customer contacts in bone field\n- PhD in a bioscience discipline", "date_new": "2012-04-13 02:24:03", "url": "http://www.amgen.jobs/xml/27868810/job", "country": "Ireland", "company": "Amgen", "title": "Regional Medical Liaison", "reqid": "14626BR", "state": null, "state_short": null, "location": "Field Based, IRL", "uid": 27868810}, {"country_short": "FRA", "city": "Neuilly-sur-Seine", "description": "Auto req 15074BR\nJob Posting Title Counsel - Responsable Affaires Juridiques\nCareer Category Law/Legal\nEmployee Subgroup Salaried FT\nCountry (State/Region) France\nLocation (City) Neuilly-sur-Seine\nAmgen Job Description Chez Amgen, notre vocation est d\u2019\u00eatre la meilleure entreprise pharmaceutique de biotechnologie, en utilisant la science et l\u2019innovation afin d\u2019am\u00e9liorer significativement la vie des patients atteints de pathologies lourdes et invalidantes.\nEntreprise dynamique n\u00e9e dans les ann\u00e9es 1980 aux Etats-Unis, Amgen a su se d\u00e9velopper et s\u2019implanter dans le monde entier. En moins de vingt ans, notre filiale fran\u00e7aise a vu cro\u00eetre parall\u00e8lement son chiffre d\u2019affaires et ses effectifs. Aujourd\u2019hui, ses 350 collaborateurs sont fiers de son statut de premi\u00e8re filiale Europ\u00e9enne et de l\u2019image dont elle b\u00e9n\u00e9ficie dans le monde de l\u2019industrie pharmaceutique.\nChez Amgen, vous travaillerez avec des collaborateurs performants et des leaders exemplaires, dans une culture impr\u00e9gn\u00e9e par nos valeurs. Notre entreprise a de belles r\u00e9ussites \u00e0 son actif, une r\u00e9elle volont\u00e9 de d\u00e9veloppement et un avenir prometteur.\n\nVous travaillez sous la responsabilit\u00e9 de la Direction Juridique Internationale du groupe Amgen. Vous repr\u00e9sentez le service Juridique pour la France et assurez les fonctions suivantes:\n\n- Support Commercial et Marketing :\no Recommandations juridiques sur les questions des clients (loi LME, droit de la concurrence, global pricing strategy..)\no Pr\u00e9paration/n\u00e9gociation des contrats (grossistes, clients, centrales)\no Support juridique en cas de litige/contentieux (en partenariat avec les d\u00e9partements marketing, commercial et r\u00e9glementaire)\n\n- Support \u00ab Compliance \u00bb :\no Conseil ponctuel aupr\u00e8s du manager Compliance (relations avec les professionnels de sant\u00e9)\no Conseil ponctuel aupr\u00e8s du d\u00e9partement r\u00e9glementaire sur le mat\u00e9riel promotionne le cas \u00e9ch\u00e9ant\no Participation au Comit\u00e9 de revue des dons\no Participation au Comit\u00e9 de revue des contrats de partenariats\n\n- Protection des donn\u00e9es :\no Point de contact pour toutes les communications avec la CNIL et toutes les questions relatives \u00e0 la protection des donn\u00e9es pour la France\no Pr\u00e9paration et soumission des dossiers \u00e0 la CNIL\n\n- Support D\u00e9veloppement (essai clinique, \u00e9tudes observationnelles) /R\u00e9glementaire :\no Revue des accords d\u2019\u00e9tudes cliniques et autres accords annexes\no Revue des formulaires de consentement patient\no Recommandations juridiques\n\n- Administration :\no Point de contact dans la gestion des relations avec nos cabinets juridiques (notamment suivi budget et approbation des factures)\no Communication r\u00e9guli\u00e8re avec la Direction juridique de Zug\nBasic Qualifications Vous avez un 3\u00e8me cycle en droit m\u00e9dical, pharmaceutique ou des industries de sant\u00e9 et de solides connaissances en droit commercial.\nVous justifiez d\u2019un minimum de 5 ans d\u2019exp\u00e9rience, dont une partie dans le secteur pharmaceutique ou des biotechnologies.\nVotre autonomie, votre esprit d\u2019analyse et votre capacit\u00e9 d'adaptation et de communication sont les atouts majeurs pour ce poste. Vous faites preuve d\u2019une grande r\u00e9activit\u00e9 et d\u2019un excellent esprit d\u2019\u00e9quipe.\nVous avez une tr\u00e8s bonne ma\u00eetrise de l\u2019anglais, \u00e0 l\u2019oral comme \u00e0 l\u2019\u00e9crit.\nPreferred Qualifications Si vous \u00eates en situation de handicap, n\u2019h\u00e9sitez pas \u00e0 informer votre interlocuteur des Ressources Humaines de toute adaptation ou outil n\u00e9cessaire au bon d\u00e9roulement de l\u2019entretien.", "date_new": "2012-04-13 02:23:41", "url": "http://www.amgen.jobs/xml/27868804/job", "country": "France", "company": "Amgen", "title": "Counsel - Responsable Affaires Juridiques", "reqid": "15074BR", "state": null, "state_short": null, "location": "Neuilly-sur-Seine, FRA", "uid": 27868804}, {"country_short": "FRA", "city": "Neuilly-sur-Seine", "description": "Auto req 15304BR\nJob Posting Title CHEF DE PRODUIT ONCOLOGIE\nCareer Category Medical Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) France\nLocation (City) Neuilly-sur-Seine\nAmgen Job Description CDD \u2013 Remplacement conge maternit\u00e9\nPoste bas\u00e9 \u00e0 Neuilly\n\nMissions :\nBas\u00e9 \u00e0 notre si\u00e8ge \u00e0 Neuilly sur Seine, au sein de la Business Unit Onco-H\u00e9matologie et sous la responsabilit\u00e9 de la Responsable Marketing Oncologie, vous \u00eates en charge du lancement d\u2019un nouvel anticorps monoclonal en Oncologie.\n\nEn collaboration avec la Responsable Marketing Oncologie, vous assurez la mise en \u0153uvre & le suivi du plan marketing de cette mol\u00e9cule ainsi que des op\u00e9rations de lancement.\nVous coordonnez la validation r\u00e9glementaire et m\u00e9dicale des outils marketing que vous d\u00e9veloppez.\nVous pr\u00e9sentez les outils marketing et motivez les forces de vente \u00e0 chaque nouvelle campagne.\nVous avez un vrai r\u00f4le de leader et d\u2019interface entre tous les d\u00e9partements de l\u2019entreprise impliqu\u00e9s sur le produit.\nVotre veille active des \u00e9volutions de notre march\u00e9 et de la concurrence vous permettra de proposer des op\u00e9rations marketing sp\u00e9cifiques adapt\u00e9es.\nVous assurez le suivi budg\u00e9taire des actions que vous engagez.\nVous \u00eates en contact avec un r\u00e9seau de leaders sur lequel vous vous appuyez pour assurer l'efficacit\u00e9 de vos actions.\nDans le cadre de votre fonction, vous \u00eates amen\u00e9 \u00e0 participer \u00e0 certains congr\u00e8s nationaux et internationaux ainsi qu'aux r\u00e9unions des forces de vente.\nVous encadrez un stagiaire.\nBasic Qualifications De formation sup\u00e9rieure (scientifique ou commerciale) id\u00e9alement compl\u00e9t\u00e9e par une sp\u00e9cialisation en marketing, vous justifiez d'une exp\u00e9rience de 2 ans en Marketing / Vente.\nVous \u00eates force de proposition dans le cadre de votre fonction.\nGrace \u00e0 votre leadership, vous avez prouv\u00e9 vos qualit\u00e9s de chef de projets et vous \u00eates reconnu pour votre capacit\u00e9 \u00e0 travailler en transversal avec des \u00e9quipes pluridisciplinaires.\nVos qualit\u00e9s relationnelles et votre bonne communication sont importantes pour \u00e9tablir une relation de confiance avec vos diff\u00e9rents interlocuteurs internes et externes.\nCr\u00e9atif, structur\u00e9 et rigoureux, vous avez un esprit d\u2019analyse et de synth\u00e8se.\nPreferred Qualifications Si vous \u00eates en situation de handicap, n\u2019h\u00e9sitez pas \u00e0 informer votre interlocuteur des Ressources Humaines de toute adaptation ou outil n\u00e9cessaire au bon d\u00e9roulement de l\u2019entretien.", "date_new": "2012-04-13 02:23:40", "url": "http://www.amgen.jobs/xml/27868803/job", "country": "France", "company": "Amgen", "title": "CHEF DE PRODUIT ONCOLOGIE", "reqid": "15304BR", "state": null, "state_short": null, "location": "Neuilly-sur-Seine, FRA", "uid": 27868803}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15168BR\nJob Posting Title Sr Associate Paralegal\nCareer Category Law/Legal\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This employment law/litigation paralegal role will be responsible for all aspects of support of employment litigation, including complex litigation matters and responses to third-party subpoenas under the supervision of an attorney. Paralegal duties can include assisting in all aspects of discovery, including document retention, collection, management and control, witness/custodian interviews, and updating the managing attorney on case status, trial preparation, trial support and case management, interaction and coordination with the business, in-house attorneys, and outside counsel and tracking information. The candidate will work in a variety of litigation management software systems. The candidate will also assist in the extraction and/or analysis of data from various database systems and various company sources.\n\nThe paralegal will be responsible for preparing drafts of contracts and modifying contract templates as appropriate, under the direction of an attorney.\nBasic Qualifications Master\u2019s degree, or\nBachelor\u2019s degree & 2 years of directly related experience, or\nAssociate\u2019s degree & 6 years of directly related experience, or\nHigh school diploma / GED & 8 years of directly related experience\nPreferred Qualifications - 7+ years paralegal experience, preferably at a mid-sized to large-sized law firm or corporate law department\n- Formal paralegal training and certification\n- Basic computer skills (Word, Excel, PowerPoint)\n- Knowledge regarding document software systems\n- Ability to perform legal research and in-depth knowledge of legal terminology and principles\n- Ability to exercise independent judgment within broad parameters as determined by the attorneys managing the cases.\n- Strong communication skills \u2013 written, oral\n- Excellent interpersonal communication skills, including diplomacy and flexibility, and the ability to interface effectively with personnel at many different levels throughout Amgen\n- Ability to effectively interview custodians and document what is learned\n- Ability to prioritize, meet deadlines, and function within a cross-functional and fast-paced environment\n- Excellent organizational and multi-tasking skills\n- Demonstrated ability to manage project work and problem solve\n- Demonstrated ability to work both as a team player and independently\n- Ability to maintain integrity of confidential and sensitive information\n- Enthusiastic, positive can do\u201d attitude and self-starter\u201d qualities enabling him or her to manage responsibilities with an appropriate sense of urgency\n- Experience with document preservation and collection issues\n- Experience with the issuance of and compliance with hold orders\n- Experience with e-discovery, including experience collecting, storing, transferring, searching, and producing electronically stored data\n- Experience in preparing contracts\n- Proficiency in a variety of litigation management software systems\n- Ability to assist in the extraction and/or analysis of data from various database systems and various company sources.", "date_new": "2012-04-13 02:23:19", "url": "http://www.amgen.jobs/xml/27868802/job", "country": "United States", "company": "Amgen", "title": "Sr Associate Paralegal", "reqid": "15168BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27868802}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15105BR\nJob Posting Title Finance Mgr\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Since 2007, Amgen\u2019s corporate strategy has quickly integrated a more pronounced role for external alliances (e.g., in & out licenses, co-development partnerships, co-promotion sales & marketing), to help identify and develop new medicines and/or commercialize late stage opportunities. This role will provide financial oversight, analyses and management reporting of external alliances by working closely with internal and external stakeholders to forecast partnership revenues and expenses. Job functions include:\n\n\u2022Primary Amgen financial interface for external alliance requests and activities\n\u2022Work closely with Amgen staff and external representatives to prepare detailed financial modeling and analysis to support strategic planning, negotiations and operational decision making. This includes working with Functional FP&A, Accounting, Corporate Development, Alliance Management, Legal, Tax, Treasury and Operations/R&D personnel.\n\u2022Understand the business drivers of each partner\u2019s activities, the full partnership P&L and its impact on Amgen\u2019s financial statements\n\u2022Provide quantitative input on valuation issues related to partnerships\n\u2022Work with Partnership Accounting to manage quarterly billing process between partners, resolve discrepancies and work with appropriate staff to ensure processes are in place to handle changes in the business\n\u2022Review and become a content expert for external alliance agreements. Provide guidance when questions arise as to why and how costs are accounted for, billed and forecasted. Ensure billable time and recoverable costs are captured and forecasted correctly.\n\u2022Ensure milestones associated with partnerships are planned for and managed appropriately through an existing database tool\n\u2022Manage royalty expense and income forecasts via input from Legal and Accounting\n\u2022Provide support as required for partner meetings. Travel may be required to meet with partner staff and ensure good working relationships.\n\u2022Be proactive in proposing new processes, strategies, etc. for partnership management\nBasic Qualifications ?Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications -MBA and/or CPA\n-5+ years experience in Financial Planning & Analysis and/or Accounting\n-Prior work experience in, and understanding of, pharmaceutical business\n-Demonstrated leadership capability and team leader/player skills\n-Strong analytic, organization, problem-solving and communication skills\n-Working knowledge of Cognos PowerPlay, TM1, GPS and SAP applications.\n-Excellent Excel and PowerPoint skills", "date_new": "2012-04-13 02:22:44", "url": "http://www.amgen.jobs/xml/27868797/job", "country": "United States", "company": "Amgen", "title": "Finance Mgr", "reqid": "15105BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27868797}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15102BR\nJob Posting Title Regulatory Affairs Director (Asia/China)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The purpose of this role is to facilitate registration of Amgen products in Asia, with a focus on China, through executing our international expansion plans; providing strategic regulatory expertise; interfacing with agencies on regulation; aligning with key Amgen cross-functional partners; integrating into Amgen\u2019s commercialization process, and continuously improving our processes and developing our talent.\n\nSpecifically:\n- Regulatory expert providing support to commercialize Amgen products in one or more priority programs in a Therapeutic Area Team(s)\n- Provide regulatory support to advance the pipeline in Asia with a focus on China\n- Primary regulatory liaison between the GRT, PSTs, the country offices. Will provide regulatory guidance to GRT, PSTs and support various Amgen teams involved in drug development and commercialization in Asia with a focus on China\n- The country GRAAS office may report into this position\n\nResponsibilities:\n- Provide leadership and manage various regulatory teams based in countries or regional hubs in the development and execution of regulatory strategies at the country/regional level by maintaining current knowledge of the regulatory requirements\n- Participate in the development of regulatory strategies by leading various Amgen teams on the regional regulatory requirements for submissions. Support the development and implementations of regional registration and compliance strategies of new and current products\n- Lead PST members and other teams for regulatory activities to ensure effective interactions with regulatory agencies in the region\n- Organize and manage various meetings for regional regulatory deliverables including Clinical Trial application (CTA), Marketing Application (MA) submissions and agency interactions\n- Oversee internal stakeholders and external vendor/contractor relationships\n- Review routine regulatory correspondence\n- Ensure QC of regulatory documentation\n- Ensure collection of functional documents in support of regulatory applications\n- Ensure development and maintenance of CTA/MA documentation in collaboration with Amgen product teams and the GRAAS regional hubs\n- Contribute to creation and maintenance of product regulatory history documents through IMR and appropriate archiving of all regulatory documents and agency communications.\n- Ensure regulatory obligations in relation t the product are properly handled\n- Works actively cross functionally within the various Amgen teams to coordinate activities related to CTA and MAAs\n- Evaluation of preferred vendors (CTOs, consultants, contractors\n- Provide strategic and timely regional regulatory input to RT, GDT, GOT and other cross-functional project meetings\n- Conduct contingency regulatory planning/risk assessment for regional development strategies and agency interactions\n- Evaluate and communicate impact of relevant regional regulations, guidance and current regulatory environment\n- Participate actively in various industry working groups to anticipate / evaluate the impact of new regulations and/or changes to the valid and current regulations\n- Provide leadership and expertise and guidance on teams for interdepartmental and cross-functional teams including, process improvement standards development, and metrics\n- Develop and deliver training materials on regulatory affairs for intra- and inter-functional purposes\n- Act within Amgen financial policies and request appropriate funds for filings\n- Coordinate preparation of controlled documents to ensure regulatory affairs operate in compliance with all regulatory duties and work in compliance with all relevant controlled documents\nBasic Qualifications - Doctorate degree and 4 years of directly related experience\nOR\n- Master\u2019s degree and 8 years of directly related experience\nOR\n- Bachelor\u2019s degree and 10 years of directly related experience\nPreferred Qualifications - Mandarin language\n- Good understanding of Chinese regulatory landscape\n\nKnowledge and Skills:\n- Demonstrated knowledge of Asian regulations, policies, procedures, drug development guidelines and compliance\n- Strong communications skills \u2013 oral and written\n- Highly developed regulatory project management skills\n- Ability to work with high degree of autonomy\n- Ability to influence and motivate others outside of direct line of authority\n- Relies on extensive experience and judgment to plan and accomplish goals and objectives\n- Ability to understand and communicate scientific/clinical information\n- Demonstrable ability to manage several complex projects in parallel\n- Relies on extensive experience and judgment to plan and accomplish goals and objectives\n- Ability to influence and motivate others outside of direct line of authority", "date_new": "2012-04-13 02:21:48", "url": "http://www.amgen.jobs/xml/27868772/job", "country": "United States", "company": "Amgen", "title": "Regulatory Affairs Director (Asia/China)", "reqid": "15102BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27868772}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15156BR\nJob Posting Title Sr Mgr Disbursements Shared Svcs\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Manage and direct day-to-day activities for one or more global sub areas within the disbursement organization (Payroll, Accounts Payable, Staff Expense Management, Operations).\n\nThe Sr. Manager is responsible for ensuring approximately $6 billion in annual disbursement spend is processed correctly and on time. This position will partner with internal departments/customers to ensure that we are driving towards best-in-class processes and organization. The individual will be a key driver of improvements from both a process and organizational perspective.\n\nAdditionally, this individual will provide oversight and strategic direction for the applicable sub areas within disbursements.\n\nIn addition to the day-to-day operations, this individual may lead and/or participate in improvement projects and must have the ability to effectively manage change. Project related responsibilities include budget, scheduling and delivering results.\n\nThis individual will also work closely with key clients, and vendors to resolve issues and drive end-to-end process improvements.\n\nThis individual will also be responsible for ensuring that our processes are compliant and for overseeing the quarterly SOX certification process for disbursements.\n\nFinally, this individual must have proven ability to build and nurture strong working relationships with all levels of the organization.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree or & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nAND\n\n2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022BS Degree in Finance / Accounting/Management or closely related field\n\u2022Experience with ERP systems (SAP)\n\u2022Proven management / leadership skills/and advanced analytical skills in a large organization\n\u2022Minimum of 7 years Accounts Payable, Payroll, Disbursement Accounting or other large scale transactional processing or equivalent experience at (at least 5 years in a management/leadership position )\n\u2022Advanced analytical skills \u2013 Advanced excel, Access etc\n\u2022Excellent written and verbal communication skills\n\u2022Proven team builder/team participant\n\u2022Ability to quickly understand and solve operational challenges/problems\n\u2022Project Management experience\n\u2022Experience with managing virtual teams (outsourced service providers)\n\n\n\n\n\u2022MBA,/ CPP / CPA / CMA etc. or other professional certification desired\n\u2022Internal/External Audit experience\n\u2022Consulting\n\u2022Accounting / Procurement experience\n\u2022Experience with managing global processes\n\u2022Knowledge of regulatory requirements related to the disbursements area", "date_new": "2012-04-11 22:08:42", "url": "http://www.amgen.jobs/xml/27821428/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Disbursements Shared Svcs", "reqid": "15156BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27821428}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15173BR\nJob Posting Title Sales Operations Senior Manager, Reporting & Analytics\nCareer Category Sales & Marketing Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Sales Operations Senior Manager will be responsible for commercial reporting and analytics in support of the Oncology sales force. This involves regular periodic reporting deliverables, ad hoc requests for reports and analytics, and proactive analysis in pursuit of insights that increase the effectiveness of the sales force and drive sales growth. This position will have significant interaction with sales leadership including the national sales director, BAI, Commercial Information Management, IS, and Marketing.\n\nResponsibilities of this role include the following:\n\n\u2022 Proactively recommend innovative improvements to reports, models, systems and standardized templates to ensure usability and value for the sales force; frequently seek feedback and suggestions from customers to further define and enhance reporting systems and processes\n\u2022 Research, analyze and resolve problems related to reporting and analytics raised by sales management and sales reps\n\u2022 Work with Sales Operations Manager (direct report) to ensure that reports are timely, accurate, and provide actionable information\n\u2022 Develop QC standards and processes and perform hands on QC as required.\n\u2022 Work closely with Incentive Compensation and POA/Activity teams to ensure that reporting deliverables properly reflect changes in those areas\n\u2022 Provide critical thinking in partnership with Sales, BAI, and others in Sales Ops and continuously develop further understanding of the Oncology business and complex product portfolio.\n\u2022 Perform complex modeling based on brand strategy, POA, and sales strategy used for fact based decision making.\n\u2022 Coach and partner with Sales Operations Manager\n\u2022 Provide training materials to the field and present to new hires as required\n\u2022 Ensure adherence to compliance/legal regulations for reporting and analytic work\n\u2022 Direct and manage contract resources to ensure that resources are aligned with business priorities and are delivering according to plan.\n\u2022 Work closely and collaboratively with the Director of Sales Operations on all analytic matters related to the sales force.\n\u2022 Provide prioritization and participate in rationalization efforts across business units for common platforms such as RADAR.\n\u2022 Communicate to appropriate audiences in the sales force regarding enhancements, future deliverables, disruptions in reporting delivery or quality.\n\u2022 Play a key role on Sales Ops Advisory Panel\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Master\u2019s degree in business, statistics, information management, life sciences\n\u2022 7+ years of experience solving business problems and analyzing data.\n\u2022 5+ years of experience working in Sales Operations or Business Analytics/Intelligence within the pharmaceutical or biotech industry.\n\u2022 Experience with sales and activity reporting, incentive compensation, POA, and internal Amgen systems such as CMA and RDS is a plus. In addition, deep knowledge of Pharmaceutical data including IMS DDD, Xponent data, and charge back data is highly desirable.\n\u2022 Strong analytical skills and attention to detail with the capability to appropriately define issues, questions, and data; to comprehend qualitative and quantitative methods to perform accurate analysis.\n\u2022 Proven experience, knowledge, and skills related to defining and optimizing reporting and analytical needs, deploying action plans, and determining future capabilities\n\u2022 Ability to consolidate and present key findings to relevant parties, explain complex concepts clearly to a variety of audiences, and demonstrate willingness to present the facts and put forth hypothesis in the face of differing opinions.\n\u2022 Strong client service orientation, user support, and vendor management skills\n\u2022 Must have strong facilitation skills to negotiate effectively in challenging situation and demonstrate creativity and innovation.\n\u2022 Ability to adjust to changing needs within the organization and to change priorities as needed\n\u2022 Demonstrated ability to translate business requirements into progressive solutions and prioritize work\n\u2022 Possess qualities such as strong organization skills, attention to detail, passion for meeting/exceeding client expectations, and intellectual curiosity to research pertinent information that further informs/educates the commercial team\n\u2022 Excellent skills in complex analytic problem solving, planning, project management, and change management\n\u2022 Substantial knowledge in one or more of the following: quantitative analysis, financial analysis, information systems, organization development, decision science, operations research, statistics, or project management.\n\u2022 Excellent communication skills \u2013 written, oral, and presentation -- appropriately gauged to a broad range of audiences from senior leadership to front-line field staff and to peers in various disciplines.\n\u2022 Demonstrated experience leading projects and/or personnel, with proven success influencing clients, customers, and team members\n\u2022 Expertise in Microsoft products Excel, Access, and PowerPoint.", "date_new": "2012-04-11 22:08:41", "url": "http://www.amgen.jobs/xml/27821425/job", "country": "United States", "company": "Amgen", "title": "Sales Operations Senior Manager, Reporting & Analytics", "reqid": "15173BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27821425}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14592BR\nJob Posting Title Sr Associate Training & Development - Information Systems\nCareer Category Information Systems\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position -- based at Amgen's corporate headquarters in Thousand Oaks, CA -- will be part of the Information Systems (IS) Learning and Performance Team within the Compliance Organization of Enterprise IS Technical Services and will be responsible for sustainment of multiple training programs, leading continual improvement projects and providing Capital/Expense funded training lead support. The successful candidate will work with IS management, training development vendors, Learning Management System support teams and other training stakeholders and services to drive value-added, effective training programs with industry best practices. Some travel may be required based on specific project assignments.\n\nKey Responsibilities\n\u2022 Responsible for supporting training programs based on existing standards to meet client and organizational objectives.\n\u2022 Manages multiple training projects, vendor commitments and internal SME deliverables in support of IS systems, services and compliance requirements.\n\u2022 Interfaces and provides consultative training support for IS Managers in assigned areas.\n\u2022 Provides guidance to IS Staff and Management on use of tools and resources to support internal team knowledge and skill development\n\u2022 Monitors assigned area for training compliance and provides preventative maintenance support.\n\u2022 Maintains course assignment requirements\n\u2022 Oversees training releases and deployments for areas as assigned\n\u2022 Provides Demand Management of inbound training requests and training documentation changes that impact staff.\n\u2022 Interfaces with internal clients to assess and develop effective and quality training deliverables.\n\u2022 Reinforces adherence to training standards.\n\u2022 Maintains and drives continual improvement cycles on training programs for Enterprise-wide systems\n\u2022 Responsible for effective delivery of training as requested. Includes virtual delivery, in-person classroom training and recording.\n\u2022 May participate on global training teams as assigned.\n\u2022 Facilitates the assignment and un-assignment of training courses/modules for staff members.\n\u2022 Provides internal process and knowledge documentation and ensures alignment with IS and Corporate document strategy\n\u2022 Provides quality control over training documentation and maintains training library\n\u2022 Develops and maintains templates for developing training content and assists SMEs, system owners and IS professionals in leveraging templates.\nBasic Qualifications Master\u2019s degree\nOR\nBachelor\u2019s degree & 2 years of directly related experience\nOR\nAssociate\u2019s degree & 6 years of directly related experience\nOR\nHigh school diploma / GED & 8 years of directly related experience\nPreferred Qualifications \u2022 Good project management skills\n\u2022 Strong customer service orientation and influencing skills to work directly with client staff and identifying performance needs.\n\u2022 Solid working knowledge on computer software programs including: Word, Excel, PowerPoint, Outlook, and SharePoint.\n\u2022 Ability to deliver training\n\u2022 Experience supporting SAP environment through training or service support\n\u2022 Demonstrates understanding of Amgen\u2019s business and culture, and ability to work effectively with staff at all levels\n\u2022 Technical competency commensurate with assigned area(s) of responsibility\n\u2022 Good interpersonal and presentation skills\n\u2022 Able to accomplish results through own work and through influencing client staff members and management\n\u2022 Able to work in a matrix team environment", "date_new": "2012-04-11 22:08:25", "url": "http://www.amgen.jobs/xml/27821421/job", "country": "United States", "company": "Amgen", "title": "Sr Associate Training & Development - Information Systems", "reqid": "14592BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27821421}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 14400BR\nJob Posting Title Sr Project Manager - Cardiovascular Therapeutics\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nUnited States - Washington\nLocation (City) Seattle\nThousand Oaks\nAmgen Job Description The Sr. Project Manager provides project management support & leadership to Research Programs / Research teams, and his/her functional line Supervisor. The Sr. Project Manager must apply project management best practices in the development, initiation, planning, execution, control & closing of projects.\n\nKey Responsibilities\nTeam Leadership- Provide operational leadership in team meetings and identify, risks and issues. Elevate team issues and work to overcome implementation obstacles. Ensure strategic alignment between Research project teams of different modalities as appropriate. Drive effective team operations, including goal setting, team charters, mgmt reviews, etc.\n\nCommunication-Maintain communication with Research leaders to ensure despite sifting priorities that support is given to those Research teams of highest priority. Provide timely, accurate communication between teams as appropriate. Communicate appropriate information on team status & issues to stakeholders.\n\nStrategic Thinking \u2013Ensure support to the highest priority projects. Actively participate in research team discussions and ensure all views are heard. Assist teams and team leaders in the development of plans, appropriate updates to plans, and management of the process to ensure Governance Board review and approval of changes to plan.\n\nRisk Management- Conduct team-level risk assessment and scenario planning to support team issues. Proactively drive development of contingency and/or risk-mitigation plans.\n\nProject Management Process- Manage all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing. Maintain a master project plan and schedule for assigned projects. Translate team plans into actionable and measurable tasks. Follow up on action items from team meetings. Establish and achieve project standards for work quality and quantity.\n\nProduct Team Deliverables- Ensure adherence to Commercialization and governance processes. Assist in the development/update of key Commercializationteam deliverables. Generate periodic updates and/or prepare formal presentations for management reporting. Provide detailed data support for portfolio management presentations. Drive the development of research plans, update plans appropriately, and manage the process to ensure Governance Board review and approval of changes to plan.\n\nThis role can be in either Thousand Oaks, CA or Seattle, WA.\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - Project Management Professional(PMP) certification desired.\n- MS, MBA or PhD\n- 7 or more years of experience in cross-functional pharmaceutical development project teams and/or experience with project management practice within the pharmaceutical industry\n- Experience in early drug development (prior to preclinical \u2013Phase1)", "date_new": "2012-04-11 22:08:16", "url": "http://www.amgen.jobs/xml/27821417/job", "country": "United States", "company": "Amgen", "title": "Sr Project Manager - Cardiovascular Therapeutics", "reqid": "14400BR", "state": "California", "state_short": "CA", "location": "Seattle, CA", "uid": 27821417}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14554BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Primary Container Engineering group under Drug Product Engineering in Thousand Oaks. This position will be required to apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position.\n\nThis position is responsible and accountable for the following:\n1) Evaluation, recommendation and selection of primary packaging materials for large and small molecule drug products.\n2) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n3) Write Technical Specifications and Bill of Materials\n4) Representing Primary Container Engineering in Drug Product and Global Operation Teams\n5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n6) Ensures that required line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n7) Ensures cGMP and regulatory compliance are met\n8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n9) Author primary container sections for all global market applications and support filing activities\n10) Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n11) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n12) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n13) Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MS in Engineering or Life Sciences\n5 to 7 of packaging engineering experience with 4+ years within the Pharma/Bio industry\nThe position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, the ability to work in multi-functional teams and adapt to rapidly changing environment.", "date_new": "2012-04-11 22:06:59", "url": "http://www.amgen.jobs/xml/27821397/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "14554BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27821397}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15093BR\nJob Posting Title Director IS (Clinical Operations)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Director IS Clinical Operations will be responsible for the successful management and execution of the IS support activities related to the Process and Product Engineering (P&PE) organization. In this capacity the Director IS Clinical Operations will also provide direct oversight to the services provided in support of the Clinical Manufacturing processes at the Thousand Oaks site. This role will also ensure that other functions at the site, which directly support Clinical Manufacturing, receive IS support such as Pilot Plants and Site Non GMP Engineering.\nThis individual will be responsible for carrying out the IS Project Portfolio the P&PE organization as well the other supporting functions.\nIn addition this position will also oversee M&A Integration activities for any Clinical Sites\n\nTravel up to 20%.\nResponsibilities include:\n\u2022 Continuously drive improvement processes & governance for IS in support of P&PE organization\n\u2022 Drive and Maintain the IS strategy in support of the assigned Client Groups\n\u2022 Successfully lead and build the Clinical Operations IS Team\n\u2022 Create strong partnerships with other Operations IS Sites and linkage with the  Corporate OIS team.\n\u2022 Manage multiple integrations\n\n\nPosition Specific Tasks:\nStrategic Influence\n\u2022 Independently determines approach to managing daily operations for assigned areas guided by Amgen policies and management guidance\n\u2022 Interprets and executes policies that directly affect work activities\n\u2022 Develops and communicates plans/objectives to team\n\u2022 Contributes to functional strategy of the supported functions\n\u2022 Delivers results through professional employees and/or skilled technicians\n\u2022 Sets project timeframes and priorities based on project objectives and ongoing assignments\n\u2022 Develops and monitors Department budgets and goals\n\u2022 Provides guidance and technical advice and becomes actively involved as required\n\nRelationship focus\n\u2022 This position will have a solid line reporting relationship to the Executive Director of OIS and a dotted line reporting relationship to the Executive Director of Clinical Operations.\n\u2022 Develops relationships with all OIS staff and Site IS staff at various management levels to resolve issues and help staff complete specific phases of projects\n\u2022 Takes accountability of the day-to-day operations of the Clinical Operations IS team\n\u2022 Partners with Corporate OIS functions to ensure alignment on strategy and execution processes\n\u2022 Collaborates with various M&A teams and represents OIS on M&A activities to ensure the Operations function is best represented\n\nLeads Clinical Operations IS team\n\u2022 Provides people/performance management, coaching and mentoring of staff\n\u2022 Directs staff on project content/approach.\n\u2022 Builds, maintain, and retain successful team\n\u2022 Manages allocation of the team resources in support of the Client Areas\n\u2022 Elevates issues that may affect successful completion of projects in a timely manner\n\u2022 Focuses on Operational Excellence as a means of driving continuous improvement\n\u2022 Ensures the outmost state of compliance with Policies and SOPs at the ATO site from an IS perspective\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nAND\n\u2022 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Bachelor\u2019s degree in Computer Science, engineering, life or physical sciences;\n\u2022 Advanced degree in Computer Science, engineering, life or physical sciences, or business (MBA)\n\u2022 12+ years of biopharma experience with 15+ years experience in operations/manufacturing/clinical manufacturing/IS, to include cGMP regulated environments\n\u2022  5 years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development.\n\u2022 Experience working cross-functionally and building collaborative working relationships; interfacing effectively with Operations and IS Senior and Executive Management to resolve issues\n\u2022 Excellent communication capabilities vertically and horizontally.\n\u2022 Ability to deal with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making\n\u2022 Certified or experience in process improvement methodologies such as Lean/Six Sigma\n\u2022 Facilitation/ Planning / Negotiation / Coaching & Project Management skills\n\u2022 Results oriented, strong adherence to timelines\n\u2022 Excellent ability to translate knowledge and build high performing teams\n\u2022  Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation.\n\u2022 Direct experience with Shop floor Automation systems (DCS, PLC/SCADA, BAS), MES systems, Manufacturing IT infrastructure, and Plant Systems & data integration, and Information Management required. Experience with Emerson DeltaV, Rockwell PLC/SCADA/Batch, OSIsoft PI data historian, Werum PAS/X, MES and BMS is preferred. Experience in other areas of Information Systems supporting manufacturing business unit is a plus.\n\u2022 Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering.\n\u2022 ERP experience is a plus.", "date_new": "2012-04-09 21:20:27", "url": "http://www.amgen.jobs/xml/27759051/job", "country": "United States", "company": "Amgen", "title": "Director IS (Clinical Operations)", "reqid": "15093BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27759051}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15163BR\nJob Posting Title Exec Dir Process Development - Network Process Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Process and Product Engineering Group (P&PE) is working as an integrated function to deliver reliable clinical supply and enable and support robust commercial processes globally. We will dramatically reshape traditional process characterization, technology transfer, validation and commercial support of both drug substance and drug product through the use of clinical production data, the deployment of transformational remote monitoring and control capabilities, and a state of the art knowledge management system.\n\nThe Executive Director of the newly created Network Process Engineering (NPE) (formerly Global Process Engineering or GPE) will have P&PE-wide responsibility to oversee the development and deployment of critical performance improving analytics and technologies. These will include Process and Systems Analytics, advanced process modeling technologies, P&PE Knowledge Management, CMC Excellence, and business performance capabilities for P&PE including OE, Business Analytics, and PMO. Responsibilities will also include P&PE Materials Science group.\n\nThe Exec Director NPE will also be responsible for working as part of the P&PE Senior Team and with our stakeholders to refine and achieve our future state.\nBasic Qualifications \u2022 Doctorate degree & 6 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 10 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 12 years of directly related experience\nAND\n\u2022 8 years of managerial experience (directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a matrixed environment)\nPreferred Qualifications \u2022 Experience within Amgen Operations of leading a Function or Plant, including supervision of senior staff, with demonstrated track record\n\u2022 15+ years of experience in the biotechnology/pharmaceutical industry including engineering and/or advanced business performance improvement\n\u2022 Advanced degree in Science or Engineering\n\u2022 MBA or financial qualification in addition to Science/Engineering degree\n\u2022 Proficient with pharmaceutical product commercialization and life cycle management; ability to recognize strategic implications of complex product development activities\n\u2022 Expertise in business analyses and its application to applied sciences\n\u2022 Excellent communication abilities; ability to communicate vertically and horizontally through multiple channels, to motivate diverse teams, and enable cross-functional collaboration", "date_new": "2012-04-09 21:20:02", "url": "http://www.amgen.jobs/xml/27759044/job", "country": "United States", "company": "Amgen", "title": "Exec Dir Process Development - Network Process Engineering", "reqid": "15163BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27759044}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15158BR\nJob Posting Title Scientist - Chemical Process Research and Development\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description A Scientist in the CPR&D Department (Chemical Process Research and Development) is responsible for development of the technology enabling manufacture of Amgen\u2019s drug substance candidates from pre-clinical to commercial scales. The Scientist will participate in drug substance development teams and be expected to develop innovative solutions to prepare Amgen drug substances.\n\nKEY RESPONSIBILITIES*:\n\nSCIENTIFIC/TECHNICAL\n\u2022 Develop technology to deliver Amgen\u2019s API candidates in a practical, efficient and safe manner.\n\u2022 Participate in drug substance teams and collaborate cross-functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner.\n\u2022 Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen\u2019s small molecule regulatory filings.\n\u2022 Work with external partners to deliver key intermediate or drug substances in support of Amgen\u2019s small molecule pipeline.\n\u2022 Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment.\n\nTEAM EXPERIENCE\n\u2022 Demonstrates ability to effectively participate on drug substance development teams as a team member or primary department representative\n\u2022 Represents the department in various departmental and interdepartmental committees that address scientific and administrative initiatives\n\u2022 Participates in and can direct team efforts directed at advancing development/technology programs within the department\n\u2022 Applies team experiences to facilitate cohesiveness and build team spirit\n\nORAL AND WRITTEN COMMUNICATION\n\u2022 Authors, or provides direction for the authorship of, technical reports or regulatory submissions which may require minimal additional editing.\n\u2022 Gives effective presentations within the department and to senior management with minimal supervision.\n\u2022 Actively creates, generates, and presents paper/presentations at scientific meetings.\n\u2022 Capable of organizing and conducting effective meetings.\n\u2022 Learns and applies facilitation and listening skills.\n\nSUPERVISING OTHERS [MAY HAVE DIRECT REPORT(S)]\n\u2022 Ensures that safe laboratory practices are followed.\n\u2022 Trains less-experienced staff.\n\u2022 Demonstrates ability to direct the activities of others.\n\nLEADERSHIP AND INFLUENCE\n\u2022 Identifies resources and develops timelines for project activities.\n\u2022 Learns to organize, plan, and control multiple project activities effectively to meet corporate timelines.\n\u2022 Effectively and actively participates on one or more project team with demonstrated ability to occupy a leadership role.\nBasic Qualifications \u2022 Master\u2019s degree & 4 years of scientific experience\nOR\n\u2022 Bachelor\u2019s degree & 6 years of scientific experience\nPreferred Qualifications \u2022 Ph.D. in Organic Chemistry and 0-5 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams\n\u2022 A BS Scientist with a minimum of 10+ years pharmaceutical industry or MS scientist 8+ years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams.\n\u2022 Experience with the techniques associated with the synthesis, purification and characterization of organic molecules\n\u2022 Experience with protein expression in E. coli and intein or sortase technology\n\u2022 Experience with large molecule purification techniques\n\u2022 Experience with synthetic organic techniques applied to peptides\n\u2022 An scientific track record which may include peer reviewed publications, scientific conference participation\n\u2022 Experience with the use of analytical instruments (HPLC, NMR, IR and MS) and interpreting the scientific data based upon these techniques.\n\u2022 Demonstrated communication and scientific writing skills.", "date_new": "2012-04-06 21:47:28", "url": "http://www.amgen.jobs/xml/27706681/job", "country": "United States", "company": "Amgen", "title": "Scientist - Chemical Process Research and Development", "reqid": "15158BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27706681}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15113BR\nJob Posting Title Sr Systems Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Sr Systems Engineer (SE) leads small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The SE drives the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality. The SE must understand and capture the user needs into system requirements and is responsible for the architectural decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied and retires technical risks as they arise on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver customer satisfaction through higher product quality.\n\nEnsuring that the quality targets are satisfied and retires technical risks as they arise on the program. Leading the design team and design control process from requirements development and design planning to design transfer. Leading the design team in the development of verification and validation planning and execution. Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction. Create and maintain artifacts (models, diagrams, documents) by evaluating needs, clarifying requirements, and analyzing use cases and dependencies to functional specifications to support hardware and software development at system and component level. Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality to evaluate and select optimum design alternatives.\n\nAccountability:\n\u2022 Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple disciplinary solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.\n\u2022 Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system.\n\u2022 Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality.\n\u2022 Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones.\n\u2022 Conduct and review advanced computer simulations to design or test products.\n\u2022 Prepare cost estimates on proposed major design products.\n\u2022 Provide technical presentation support and consultation to marketing.\n\u2022 Represent company unit in customer or field force contacts.\n\u2022 Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs.\n\u2022 Produce innovative technical solutions to customers.\n\u2022 Prepare technical proposals for competitive bids.\n\u2022 Develop potential applications to exploit new business opportunities.\n\u2022 Collect and analyze information on competitor product performance.\n\u2022 Utilize project planning and monitoring methods to ensure timely completion.\n\u2022 Originate and communicate concepts which could lead to new products.\n\u2022 Review and approve completed design work.\n\u2022 Actively contributes to identifying and pursuing new technological opportunities\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Masters Degree in Engineering and 5 years progressive experience as an engineer or scientist working with Medical Devices, ideally Class II and Class III\n\n\u2022 Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components.\n\u2022 Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product.\n\u2022 Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc).\n\u2022 Experience in model-based design and UML and Small scale device assembly experience.\n\u2022 Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams.\n\u2022 Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance)\n\u2022 Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)\n\u2022 Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc.\n\u2022 Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position\n\u2022 Familiar with the following standards:\nUS Good Manufacturing Practices \u2013 21CFR820\nQuality Management \u2013 ISO 13485\nRisk Management \u2013 ISO 14971\nEU Medical Device requirements \u2013 Council Directive 93/42/EEC\nMedical Electrical Equipment \u2013 EN 60601\n\u2022 Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software.\nexperience highly desired\n\u2022 Practical experience in configuration management and change control process/requirements \u2013 CCB (change control board), CIT (change implementation team) concepts\n\u2022 Experience working with cross department teams to analyze feasibility and ensure that all systems are being built in consideration with one another\n\u2022 Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives.\n\nDesired Characteristics\n\u2022 Demonstrated applied lean 6 Sigma competency\n\u2022 Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current.\n\u2022 Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.\n\u2022 Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program.\n\u2022 Strong interpersonal skills\n\u2022 Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program\n\u2022 INCOSE certification or formal Systems Engineering training/certification", "date_new": "2012-04-06 21:46:17", "url": "http://www.amgen.jobs/xml/27706661/job", "country": "United States", "company": "Amgen", "title": "Sr Systems Engineer", "reqid": "15113BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27706661}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 15110BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - Dayton, OH\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Ohio\nLocation (City) Field Based\nAmgen Job Description Territory: (#)15205 Dayton, OH - covering Dayton and Lima, OH\n\nAs a Senior Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.\n\nAs a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager\n\nAmgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 years of directly related experience\nOR\n- Associate\u2019s degree & 6 years of directly related experience\nOR\n- High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications Two+ years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries\n- Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred\n- Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred\n- Local Market knowledge\n- A Bachelor's degree in Life Sciences or Business Administration\n\nCore Competencies:\n- Planning and Organizing Work\n- Engaging Others Through Effective Communication\n- Drive to Achieve\n- Individual Leadership and Impact", "date_new": "2012-04-05 19:45:34", "url": "http://www.amgen.jobs/xml/27668156/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - Dayton, OH", "reqid": "15110BR", "state": "Ohio", "state_short": "OH", "location": "Field Based, OH", "uid": 27668156}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15121BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices.\n\nThis position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n- Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.\n- Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n- Write Technical Specifications and Bill of Materials\n- Representing PD&E in Drug Product and Global Operation Teams\n- Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n- Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n- Ensures cGMP and regulatory compliance are met\n- Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n- Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n- Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - MS in Packaging, Engineering or Life Sciences\n- 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry\nDemonstrated Competencies/Skills:\n- Independent thinker with demonstrated skills working in teams or leading\nproject teams\n- Strong Interpersonal and communication skills", "date_new": "2012-04-05 19:45:29", "url": "http://www.amgen.jobs/xml/27668150/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "15121BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27668150}, {"country_short": "USA", "city": "Bothell", "description": "Auto req 13445BR\nJob Posting Title Product Quality Director\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nUnited States - Colorado\nUnited States - Puerto Rico\nUnited States - Rhode Island\nUnited States - Washington\nLocation (City) Bothell\nBoulder\nField Based\nJuncos\nLake Centre\nLongmont\nSeattle\nThousand Oaks\nWest Greenwich\nAmgen Job Description The successful candidate will become a Product Quality Leader (PQL). The individual will provide technical expertise and project leadership to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Global Operations Teams (GOT) and product goals for Amgen products. As a product expert in Quality, the Product Quality Leader has responsibility for working directly with other PQLs, Global Operations Leader (GOLs), International Expansion (IE), Corporate Quality Control (QC), site QC, Regulatory, Process Development (PD), Quality Assurance (QA) etc. on the resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions, international expansion and inspections related to Amgen product(s). The individual will be directly responsible for Product Quality related tasks in support of Amgen\u2019s late-stage clinical and commercial products. These tasks include but are not limited to; ownership, authoring and review of documents, and execution of transactions in relevant GMP systems (change control, etc.). In addition to these responsibilities, the candidate will be expected to play a role in supporting other product quality issues and initiatives intended to ensure the overall product health.\nThis position can reside at Amgen sites in Thousand Oaks, CA, CO, RI or Puerto Rico.\nBasic Qualifications ? Doctorate degree & 4 years of directly related experience\nOR\n? Master\u2019s degree & 8 years of directly related experience\nOR\n? Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications B.S. in biochemistry, biology, or a related protein/biotechnology sciences field 10 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment, OR\n- an Advanced degree in biochemistry, biology, or a related protein/biotechnology sciences field and 7 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience.\n- 10+ years working in a regulated environment (either direct GMP or technical support)\n- 4 + years experience with authoring or review of biological license applications, IND, supplements or similar regulatory documentation.\n- 4 + years experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances\n- Experience in Project Management in support of biopharmaceutical development\nThere is a strong preference for candidates who are familiar with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions. Prior experience in direct interaction with regulatory agencies during inspections or meetings is helpful. Knowledge of analytical techniques used for biologics product quality control. Understanding of biopharmaceutical bulk and drug product development and manufacturing. Familiarity with Bispecific T cell Engager (BiTE) antibody technology. In-depth knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals. Previous experience working on a cross-functional team in a matrix environment.\nExcellent written and verbal communication skills, including facilitation and presentation skills.", "date_new": "2012-04-05 19:44:51", "url": "http://www.amgen.jobs/xml/27668144/job", "country": "United States", "company": "Amgen", "title": "Product Quality Director", "reqid": "13445BR", "state": "California", "state_short": "CA", "location": "Bothell, CA", "uid": 27668144}, {"country_short": "DEU", "city": "Munich", "description": "Auto req 15073BR\nJob Posting Title Praktikant f\u00fcr die Medizinische Abteilung\nCareer Category Medical Services\nEmployee Subgroup Co-Op FT Salaried\nCountry (State/Region) Germany\nLocation (City) Munich\nAmgen Job Description Amgen ist weiter auf Wachstumskurs und steht vor der Einf\u00fchrung mehrerer innovativer Produkte. Wir\nbieten motivierten und leistungsorientierten Pers\u00f6nlichkeiten Gelegenheit, in einem internationalen,dynamischen und innovativen Umfeld erste berufliche Erfahrungen zu sammeln.\n\nWir suchen ab Mai 2012 einen engagierten und motivierten Studenten der Pharmazie, Humanbiologie,\nBiologie, Biochemie oder Medizin als\n\nPraktikant (m/w) im Bereich Medizin:\nLernen Sie zwei Bereiche unserer medizinischen Abteilung kennen:\n\nBereich Medical Communications (60%):\no \u00dcberblick des T\u00e4tigkeitsspektrums wissenschaftlicher Produktexperten\no Wissenschaftliche Pr\u00e4sentationen\no Literaturzusammenfassungen\no Kongressberichte\no Ver\u00f6ffentlichungen\n\nBereich Regional Medical Project Management (40%)\no \u00dcberblick des T\u00e4tigkeitsspektrums der regionalen medizinischen Projektleiter\nBasic Qualifications \u2022 Naturwissenschaftliches Studium, Vordiplom vorausgesetzt\n\u2022 Gute Kenntnisse im Umgang mit dem PC (MS Office)\n\u2022 Sehr gute Deutsch- und Englischkenntnisse - schriftlich wie m\u00fcndlich\n\u2022 Gute kommunikative F\u00e4higkeiten - schriftlich wie m\u00fcndlich\n\u2022 Neugier und rasche Auffassungsgabe\n\u2022 Initiative, Kreativit\u00e4t, Teamgeist, Belastbarkeit und Flexibilit\u00e4t\n\u2022 Zeit f\u00fcr ein 6-monatiges, verg\u00fctetes Praktikum, gerne auch Pflichtpraktikum\nPreferred Qualifications Was wir Ihnen bieten:\n\nSie gewinnen hervorragende Einblicke in das weltweit gr\u00f6\u00dfte Biotechnologie-Unternehmen und erhalten\ndie Gelegenheit, Ihre fachlichen F\u00e4higkeiten zu erweitern. Im praktischen Arbeitsumfeld k\u00f6nnen Sie\nt\u00e4glich Ihre pers\u00f6nlichen und sozialen Kompetenzen weiter entwickeln. Unser Arbeitsstil ist von Offenheit,Fortschritt und dem Willen zum Erfolg gepr\u00e4gt - der Teamgedanke wird gro\u00df geschrieben.\n\nBitte \u00fcbermitteln Sie uns Ihre Bewerbung online \u00fcber unser Karriereportal. Selbstverst\u00e4ndlich bewahren wir alle datenschutzrechtlichen Bestimmungen.\n\nF\u00fcr Fragen vorab steht Ihnen Frau Martina Rech (Staffing Manager) unter der\nTelefonnummer (089) 14 90 96-11 12 gerne zur Verf\u00fcgung.", "date_new": "2012-04-05 19:44:40", "url": "http://www.amgen.jobs/xml/27668141/job", "country": "Germany", "company": "Amgen", "title": "Praktikant f\u00fcr die Medizinische Abteilung", "reqid": "15073BR", "state": null, "state_short": null, "location": "Munich, DEU", "uid": 27668141}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14591BR\nJob Posting Title Sr Mgr Finance\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position provides financial, analytical and decision support to the Oncology Business Unit for Neulasta, Neupogen, and Vectibix in Global Commercial Operations \u2013 Financial Planning & Analysis.\n\nThe position supports revenue modeling for the monthly close, latest estimates, annual planning and long range planning activities. This role requires the ability to develop an understanding of the business drivers, analyze and clearly communicate financial implications of the changing reimbursement environment, build effective relationships with the business unit leaders, and analyze and clearly communicate financial results and direction to client groups and assess competitive threats. The position will also be intimately involved in the analysis, development and implementation of various productivity initiatives.This position will also interact with numerous functions, including the Brand team, Pricing, Contracting, Forecasting, Sales, Global Marketing, and Reimbursement.\n\nAdditional responsibilities include financial modeling, preparation and presentation of results and ideas to senior management and performing regular account analyses to anticipate and resolve issues. The successful candidate will demonstrate the ability to take initiative and work with a minimum of direction, to provide leadership and key support on multiple projects, to manage cross-functional teams, to formulate and clearly deliver complex information, issues and recommendations in both written and oral form to senior management, and develop and use complex financial models to facilitate decision making. Excellent analytical skills, strong proficiency with Excel and PowerPoint, a thorough understanding of corporate finance concepts, and provocative and critical thinking are essential.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications 6+ years experience in functions requiring business / financial analysis and presentation of results and recommendations to Senior Management.\nProficiency with Excel and PowerPoint is a must", "date_new": "2012-04-04 03:03:30", "url": "http://www.amgen.jobs/xml/27630480/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr Finance", "reqid": "14591BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630480}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14603BR\nJob Posting Title Accounting Sr Mgr\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The general responsibilities of this position include: external financial reporting, researching, analyzing and providing guidance on reporting matters and contributing to process improvements as they relate to external reporting.\n\nSpecific Responsibilities:\n\u2022Contribute to the preparation of quarterly and annual SEC filings (10-Q, 10-K, etc.), which involves working with a cross-functional team including Legal, Investor Relations, Corporate Communication, Financial Planning & Analysis (FP&A) and others.\n\u2022Contribute to the preparation of other external reports including the Annual Report, Certain subsidiary or branch financial statements etc.\n\u2022Ensure that financial statements comply with US GAAP and SEC rules and regulations and meet the highest standards of relevance, transparency, and clarity.\n\u2022Work closely with Investor Relations and FP&A to support quarterly earnings release process and other internal and external communications with a primary focus on accuracy and appropriateness of financial and accounting related amounts and disclosures.\n\u2022Contribute to the Company\u2019s positions on accounting and reporting issues raised in SEC comment letters and other external inquires.\n\u2022Monitor accounting standards and rule changes (FASB, SEC, etc.) and participate in assessing their impact on the Company\u2019s disclosures. Stay current on all pending accounting and disclosure issues that may affect Amgen through attending external seminars, holding discussions with counterparts in other pharmaceutical companies, and monitoring the regulatory filings of other public filings of other companies.\n\u2022Provide disclosure guidance to management and others and help identify and resolve related issues.\n\u2022Contribute to the development of accounting and financial reporting policies.\n\u2022Contribute to communication of financial results to the Audit Committee of the Board of Directors.\n\u2022Contribute to process improvement initiatives in the external reporting area, including those involving a broad spectrum of stakeholders.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications CPA designation; and\n-Minimum 8 years of directly related experience in accounting and financial reporting.\n-Combination of public accounting and financial reporting experience.\n-4-6 years Big 4\u201d accounting experience is preferred.\n-Demonstrated leadership capability and team leader/player skills.\n-Strong interpersonal skills; ability to influence personnel across functions and levels.\n- Strong written, verbal communication, problem-solving and presentation skills.\n-Pharmaceutical/Biotech experience.\n-Strong Excel and PowerPoint skills.\n-Strong project management skills.", "date_new": "2012-04-04 03:03:29", "url": "http://www.amgen.jobs/xml/27630479/job", "country": "United States", "company": "Amgen", "title": "Accounting Sr Mgr", "reqid": "14603BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630479}, {"country_short": "IRL", "city": "Cork", "description": "Auto req 14214BR\nJob Posting Title Engineering Projects Mgr\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Cork\nDublin\nField Based\nDun Laoghaire\nAmgen Job Description Engineer Project Manager - Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the packaging group and be responsible for the execution of all projects in that area. The equipment engineer reports to the Sr. Manager Manufacturing \u2013Packaging. The candidate will apply technical expertise in the management of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes.\n\nResponsibilities include:\n\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Engineering Project lead for Packaging\n\u2022 The provision of manufacturing input to all capital projects relating to the area.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 All design reviews associated with equipment purchases.\n\u2022 The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.\n\u2022 Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.\n\u2022 Continuous improvement programs\n\u2022 Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-04-04 03:03:14", "url": "http://www.amgen.jobs/xml/27630466/job", "country": "Ireland", "company": "Amgen", "title": "Engineering Projects Mgr", "reqid": "14214BR", "state": null, "state_short": null, "location": "Cork, IRL", "uid": 27630466}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14421BR\nJob Posting Title Biosimilars Strategic Planning & Ops Director, Commercial\nCareer Category Corporate Services\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Department Overview:\nAmgen Biosimilar Strategic Planning & Operations is accountable for:\n\u2022 Amgen\u2019s corporate (policy and competitive) preparation for biosimilars entry in the U.S.\n\u2022 Oversight and coordination of global initiatives to retain and improve biosimilars policy in EU, Latin America and Asia\n\u2022 Support and integration of our brand and biosimilars businesses\n\nJob Summary:\nLead corporate level (e.g. non-brand) commercial preparation for biosimilars; coordinate with biosimilars communications and regional leads, brands, payer marketing and biosimilars unit to execute an integrated communications platform\n\nRole Purpose and Scope:\nResponsible for organizational preparation for intense but highly constrained competition and delivering a coordinated \u2018platform\u2019 of competitive actions/differentiation opportunities at the corporate and cross-brand level, this role will provide input and assistance to PSTs and brands on opportunities to differentiate individual products in context of system-wide changes in global healthcare environment\n\n\u2022 Contributes to organizational thought leadership\n\u2022 Contributes to business results through quality of results, advice and decisions related to the operations of the discipline\n\u2022 Contributes through application of expertise associated with a professional body of commercial knowledge to complete tasks, assignments and/or long-term projects\n\u2022 Develops mutually beneficial strategic alliances with internal and external contacts\n\u2022 Will have direct and/or dotted line reports\n\u2022 Financial approval consistent with grade ($250,000+)\n\nResponsibilities:\nCommercial Lead & Biosimilar SME:\n\u2022 Partner with legal and regulatory team members to fully understand the relevant laws, regulations and precedent that define our freedom to operate commercially\n\u2022 Collaborate to identify and develop appropriate mechanisms to compete effectively with biosimilars\n\u2022 Collaborate on comprehensive recommendations for CEO staff decision-making\n\u2022 Ensure integration with brand leadership\n\u2022 Participate in relevant commercial and brand sub-teams, meetings and workshops to coordinate corporate activities and alignment\n\nCorporate Commercial Preparation:\n\u2022 Identify and develop potential strategies and tactics to differentiate from a new type of competition at the corporate or multi-brand level\n\u2022 Identify key milestones and/or inflection points for overall evolution of biosimilars markets in EU, Canada, U.S. and EM\n\u2022 Establish broad intake scope; narrow opportunities to those suitable within current timing, legal and P&L constraints\n\u2022 Ensure integration with brand leadership\n\u2022 Collaborate with biosimilars team SMEs to develop proactive opportunities\n\u2022 Partner with biosimilars communications and \u2018Made by Amgen\u2019 team to execute approved campaigns\n\nInterpret Competitive Intelligence:\n\u2022 Support brand teams with detailed analysis of CI in context of protein science, clinical development outcomes and established regulatory precedent\n\u2022 Partner with CI to develop clear and contemporaneous reports for brand teams, payer teams and executive management\n\nStrategic Planning and Operations:\n\u2022 Develop and share broadly a comprehensive understanding of the future landscape for biosimilars and underlying behaviors of key decision makers\n\u2022 Understand potential dimensions along which Amgen can successfully differentiate and compete with a biosimilar or other \u2018closely related\u2019 product\n\u2022 Develop and maintain a body of benchmarks and case studies relevant to emerging biosimilars competition\n\nPolicy Assessment and Implications:\n\u2022 Partner with policy director to predict, understand and translate emerging implications of rulemaking\n\u2022 Identify future policy needs and timing\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications \u2022 Masters or Doctorate in protein science or related technical discipline\n\u2022 Biologic drug commercialization, sales and marketing experience\n\u2022 Proven track record of collaborative and constructive relationships with legal and regulatory subject matter experts\n\u2022 Significant EC/EMA and U.S. commercial experience and market analysis\n\u2022 Extensive analytics and market research experience; highly competent working within global compliance requirements\n\u2022 Direct knowledge of global biosimilars marketplace and recent commercial strategies and tactics\n\u2022 In depth knowledge of commercial communications\n\u2022 In depth knowledge of EU and U.S. laws and regulations related to commercial communication, promotions and enforcement\n\u2022 Knowledge of or experience in U.S. and/or EU pricing and competitive dynamics", "date_new": "2012-04-04 03:03:13", "url": "http://www.amgen.jobs/xml/27630465/job", "country": "United States", "company": "Amgen", "title": "Biosimilars Strategic Planning & Ops Director, Commercial", "reqid": "14421BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630465}, {"country_short": "CZE", "city": "Prague", "description": "Auto req 13584BR\nJob Posting Title Product Mgr\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Czech Republic\nLocation (City) Prague\nAmgen Job Description Drives motivation of sales force towards brand aspiration (cycle and launch meetings)\nDevelops and implements Country Brand Plan in full congruence with International Brand Plan\nDesigns and executes promotional activities (detail aids, message scripts, advertising, congresses, etc.) in line with international branding and key messages\nDevelops LRP with Business Planner\nProposes national sales target and achieves agreement with Business Unit Leader and Sales/District Managers\nPartners with international PM\nTranslates/implements international brand campaign locally\nAnalyses market research and develops POA\nCoordinates competitive intelligence and drives competitive action plans\nPartners with the Medical Affairs Manager to optimise the brand performance (goals of clinical trials, KOL development, etc.)\nAgrees with other PM in Franchise Team on joint projects\nRecruits and manages external vendors\nIdentifies business opportunities and develops business cases\nBasic Qualifications Minimum Requirements\nAcademic education or experience from similar positions\nMinimum 5 to 8 years of experience in industry\n1 to 3 years as a Pharmaceutical Sales Representative\nMinimum 2 years of experience as a Product Manager\nFluency in English, both oral and written communications\nFinancial and budgeting skills and experience\nDocumented track record of product launch\nComputer skills (MS Office programs)\nTenure at last two jobs for at least 2 years each", "date_new": "2012-04-04 03:03:01", "url": "http://www.amgen.jobs/xml/27630464/job", "country": "Czech Republic", "company": "Amgen", "title": "Product Mgr", "reqid": "13584BR", "state": null, "state_short": null, "location": "Prague, CZE", "uid": 27630464}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15078BR\nJob Posting Title Principal Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Primary Container Engineering group under Drug Product Engineering in Thousand Oaks. This position will be required to apply advanced and diverse engineering principles to execute the proper design, qualification and implementation of Primary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position.\n\nThis position will be located in Thousand Oaks, California.\n\nThis position will be required to:\n\n1) Qualify fill finish processes with cartridge systems. Including cartridge preparation, filling and sealing in pilot to commercial scale.\n2) Evaluate, recommend and select primary packaging materials for large and small molecule drug products.\n3) Write test and execute protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n4) Write Technical Specifications and Bill of Materials\n5) Perform technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n6) Ensure cGMP and regulatory compliance are met\n7) Author primary container sections for all global market applications and support filing activities\n8) Collaborate with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MS or Ph. D in Materials Science, Chemical Engineering or Mechanical Engineering\n6 to 10 years (or more) of experience with 4+ years within the Pharma/Bio industry\n\nDemonstrated General Competencies/Skills:\n1. Independent thinker with demonstrated skills working in teams or leading project teams\n2. Strong Interpersonal and communication skills\n\nDesired Technical Competencies/Skills (any one or multiple combination thereof):\n1. Demonstrated experience with CAD software for modeling container closure systems. Example: Use of Solid WorksTM drawings to assess mechanical interfaces for device integration as well as support for specifications, standards, methods as well as concept modeling.\n2. Design for manufacturability experience (6 Sigma, FEA, etc)", "date_new": "2012-04-04 03:02:49", "url": "http://www.amgen.jobs/xml/27630458/job", "country": "United States", "company": "Amgen", "title": "Principal Packaging Engineer", "reqid": "15078BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630458}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14418BR\nJob Posting Title Biosimilars Strategic Planning & Ops Director, Technical Policy\nCareer Category Corporate Services\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Department Overview:\nAmgen Biosimilar Strategic Planning & Operations is accountable for:\n\u2022 Amgen\u2019s corporate (policy and competitive) preparation for biosimilars entry in the U.S.\n\u2022 Oversight and coordination of global initiatives to retain and improve biosimilars policy in EU, Latin America and Asia\n\u2022 Support and integration of our brand and biosimilars businesses\n\nJob Summary:\nProvide team leadership on critical policy measures and inform corporate strategy on appropriate methods to support Amgen\u2019s scientific principles as well as originator and biosimilars objectives. Conduct detailed analysis of biosimilars policy. Provide external engagement leadership; represent Amgen and industry in media, communications; publication development, trade association leadership\n\nRole Purpose and Scope:\nResponsible to shape scientific policy by providing technical expertise and global leadership on biosimilars policy matters, this role will translate science for lay audiences; develop, review and deliver external technical communications; conduct policy/regulatory engagement and trade association leadership; support legal analysis\n\n\u2022 Contributes to organizational thought leadership\n\u2022 Contributes to business results through quality of results, advice and decisions related to the operations of the discipline\n\u2022 Contributes through application of expertise associated with a professional body of scientific/technical or policy knowledge to complete tasks, assignments and/or long-term projects\n\u2022 Develops mutually beneficial strategic alliances with internal and external contacts\n\u2022 Will have direct and/or dotted line reports\n\u2022 Financial approval consistent with grade ($250,000+)\n\nResponsibilities:\nManage external government and policy communications:\n\u2022 Influence a broad spectrum of stakeholders toward setting science-based standards for biosimilars\n\u2022 Publish scientific findings, best practices and science-based positions\n\u2022 Represent Amgen and the innovator industry in policy testimony, media interactions and public fora\n\u2022 Lead trade association key issue and/or technical teams\n\u2022 Develop collaborative alliances with internal and external scientific experts\n\nTeam Leadership and Collaboration:\n\u2022 Act as comparability / biosimilarity subject matter expert for Amgen external communications reviews\n\u2022 Define Amgen positions on the scientific, medical and regulatory aspects of biosimilars and the establishment, improvement and reinforcement of sound scientific policy for biologic medicines\n\u2022 Work in multi-disciplinary team alongside medical, legal and regulatory on analysis and position development\n\nTechnical Expert:\n\u2022 Evaluate biosimilars policy for scientific rationale and basis\n\u2022 Coordinate characterization and analysis of biosimilars products\n\u2022 Develop internal and cross-team communication of Amgen and industry experience in developing and manufacturing biologics, and now biosimilars\n\nStrategic Planning:\n\u2022 Contribute to organizational thought leadership\n\u2022 Work in partnership with team leadership to develop plans that support corporate objectives\n\u2022 Collaborate with law to prepare for areas in which regulatory and judicial clarity may be needed\n\nIntegrated Policy & Corporate Execution:\n\u2022 Develop recommendations for science-based policies that put patient safety first\n\u2022 Work with Competitive Intelligence to connect data points into information and knowledge\n\u2022 Contribute to executive decision-making through application of expertise and professional body of scientific/technical knowledge\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications \u2022 Masters or Doctorate in protein science or related technical discipline\n\u2022 Biologic drug development, manufacturing and/or quality experience\n\u2022 Significant EC and EMA experience\n\u2022 Direct knowledge of global biosimilars policy\n\u2022 In depth knowledge of WHO scientific biosimilars standards\n\u2022 In depth knowledge of EU laws and regulations related to biosimilars\n\u2022 Knowledge of or experience in development of U.S. and/or EU biosimilars products", "date_new": "2012-04-04 03:02:48", "url": "http://www.amgen.jobs/xml/27630457/job", "country": "United States", "company": "Amgen", "title": "Biosimilars Strategic Planning & Ops Director, Technical Policy", "reqid": "14418BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630457}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14574BR\nJob Posting Title Sr Packaging Engineer\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Device & Package Engineering (D&PE) group under Global Drug Product and Device Development in Thousand Oaks, CA. The position falls within 2 different categories in D&PE: Pre-Commercial and Commercial Engineering, supporting global supply, launch delivery, partnerships/acquisitions and devices.\n\nThis position will apply advance and diverse engineering principles to execute the design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. This role requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n- Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.\n- Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.\n- Write Technical Specifications and Bill of Materials\n- Representing PD&E in Drug Product and Global Operation Teams\n- Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n- Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n- Ensures cGMP and regulatory compliance are met\n- Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed\n- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n- Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.\n- Oversees project implementation of critical new package platforms.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - MS in Packaging, Engineering or Life Sciences\n- 7 or more years of packaging/engineering experience with 4+ years within the Pharma/Bio industry\nDemonstrated Competencies/Skills:\n- Independent thinker with demonstrated skills working in teams or leading\nproject teams\n- Strong Interpersonal and communication skills", "date_new": "2012-04-04 03:02:42", "url": "http://www.amgen.jobs/xml/27630449/job", "country": "United States", "company": "Amgen", "title": "Sr Packaging Engineer", "reqid": "14574BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27630449}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14414BR\nJob Posting Title Principal IS Architect (Enterprise IS Technology Services Principal Design Engineer) - Security\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Principal Design Engineer for Amgen's Enterprise IS Technology Services (EISTS)Design & Engineering is responsible for the development, delivery, and life cycle of Amgen IS Infrastructure technologies in identity, business partner connectivity, messaging and communications, security, and related areas. As a multi-disciplinary expert, the successful candidate must provide Engineering direction across the organization in their areas and relationships to it from other areas. This position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle.\n\nJob Responsibilities\n\u2022 Be accountable for developing, delivering and maintaining an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions from their areas.\n\n\u2022 Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners.\n\n\u2022 Accountable to ensure IS projects leverage and maximize value Engineered solutions from their portfolio of technologies through strong collaboration within EISTS and across IS.\n\n\u2022 Provide technical leadership and implementation support to projects requiring cross-functional integration expertise, including co-development of project plans.\n\n\u2022 Lead the introduction of new EISTS Technologies into their portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency.\n\n\u2022 Maintain the technology portfolio life cycle for their areas within EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks.\n\nLead alignment of services and operations for their areas within EISTS, to increase efficiency and reduce the risk of unmanaged faults in the service and operational pipeline.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Master\u2019s degree\n\u2022 Bachelor\u2019s Degree in Information Systems, Computer Science, or Electronics\n\u2022 10 + years experience working within Information Systems\n\u2022 7+ years experience delivering large and small IS infrastructure technology solutions in global companies using Information Technology and Services in regulated environments. Additional experience with technology supply and sourcing companies a plus.\n\u2022 5+ years developing integrated business-to-business and business-to-consumer solutions, including detailed technical experience with key Internet technologies and protocols (e.g. TCP/IP, HTTP, SMTP, DNS).\n\u2022 5+ years experience with security and identity infrastructure, including LDAP, Microsoft Active Directory, PKI, and SSL/TLS.\n\u2022 5+ years experience with service design and operational alignment. Specific experience applying ITIL to infrastructure service delivery and operation is a plus.5+ years biotechnology or pharmaceutical experience are a plus.\n\u2022 Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments.\n\u2022 The ability to function in multiple roles based on project demands.\n\u2022 Strategic delivery experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines.\n\u2022 Excellent oral, written and interpersonal communication skills.\n\u2022 Experience with a range of IT service, architecture, engineering, and design frameworks and languages, including UML and/or BPMN a plus.\n\n\u2022 This position requires a senior and credible IS Infrastructure technology design and delivery engineer, with broad experience and demonstrated success. It requires a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices.\n\u2022 Learning agility, technical excellence, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes.\n\u2022 This individual will leverage his/her extensive experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services", "date_new": "2012-04-02 23:26:51", "url": "http://www.amgen.jobs/xml/27593255/job", "country": "United States", "company": "Amgen", "title": "Principal IS Architect (Enterprise IS Technology Services Principal Design Engineer) - Security", "reqid": "14414BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27593255}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14573BR\nJob Posting Title Principal IS Business System Analyst (Enterprise IS Technical Services Programs Portfolio Planning Senior Manager)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Enterprise IS Technical Services (EISTS) Portfolio Planning Senior Manager is responsible for planning and coordinating resources for all EISTS project resources, reporting to the Executive Director EISTS Programs and Strategy. The position combines both resource planning and execution and financial planning responsibilities.\n\nJob Responsibilities:\n\n\u2022 Coordinates with the Program Leads, Operations Service Owners, and Client Services Managers to develop and manage project and program resources, cost estimates and resource allocation.\n\u2022 Coordinates with Finance and other portfolio governing bodies to keep current the latest estimate annual budgets, resource plans, and other portfolio related activities.\n\u2022 Works with key stakeholders to continuously optimize project resourcing.\n\u2022 Communicates status of overall EAS portfolio and facilitates communication of projects to EISTS leadership and other key stakeholders.\n\u2022 Understands and communicates changes to budget and monitoring processes and deliverables. As required, provides training to EISTS staff on project budget processes.\n\u2022 Develops improvement techniques within Programs management to achieve process efficiencies, innovation, and operational excellence.\n\u2022 Manages the EISTS portfolio using Amgen\u2019s EPPM portfolio management tool. Supports PMs with the creation and editing of projects in the tool. Ensures project change and close out notifications and done in a timely manner.\n\u2022 Facilitates the project resource planning and budget initiation and approval and supports project managers through the capital funding process.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Master\u2019s degree\n\u2022 Bachelor\u2019s Degree in Engineering, Information Systems, Computer Science, Business, Finance or the Life Sciences.\n\u2022 Strong financial background\n\u2022 5 + years experience working within information systems and/or project management\n\u2022 Strong oral, written and interpersonal communication skills\n\u2022 Knowledge of Amgen Business and IS practices as well as previous experience with global projects\n\u2022 Sound experience managing of IT, business analysis or business change\n\u2022 IT Financial management expertise including competency in business analysis and business case development.\n\u2022 Proven influencer and communicator with stakeholders at all levels.\n\u2022 Delivering results: ability to plan and organize self and work in order to achieve objectives and targets. Is determined to deliver outcomes and is able to overcome obstacles in order to move forward. Accountable for the delivery of outcomes, strives to meet and exceed the expectations of customers.\n\u2022 Influencing and negotiating: can influence and challenge at executive level.\n\u2022 Working with others: ability to work effectively with colleagues, managers, suppliers and stakeholders. Understands the importance of developing effective partnership relationships with key suppliers.", "date_new": "2012-04-02 23:25:46", "url": "http://www.amgen.jobs/xml/27593245/job", "country": "United States", "company": "Amgen", "title": "Principal IS Business System Analyst (Enterprise IS Technical Services Programs Portfolio Planning Senior Manager)", "reqid": "14573BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27593245}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14575BR\nJob Posting Title Sr Mgr GRAAS Operations (Strategy and External Operations)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role shapes and drives key GRAAS and corporate initiatives delivering productivity and operational excellence, in particular sourcing.\n- Influence and execute transformational business strategies particularly Amgen\u2019s global operating model and sourcing\n- Deliver productivity/op-ex initiatives including design and leadership of selected process improvements in partnership with GRAAS and corporate leaders\n- Lead all aspects of financial value capture from these initiatives including financial modeling, allocations, NPV recovery, and support budgeting and planning\n- Provide execution of global sourcing strategies, and other GRAAS strategies\n\nKey Activities of this role include:\n-Supplier Management\n- Lead ongoing oversight of supplier engagement\n- Review and approve metrics/targets for supplier operations\n- Lead/participate in resolution of business / financial / productivity or site operatins issues with suppliers\n- Support/lead management of supplier operations (i.e. scheduling, expenses, status reporting, issue/risk management etc.)\n- Support monitoring of completion of work in accordance with service level agreements (SLAs) and contracts\n- Leverage best practices in project management to ensure quality performance from supplier\n- Full ownership of the financial models used/needed for GRAAS to oversee productivity targets, financial value capture, and supplier financials\n- Review and maintain KCI, KPS, Metrics, compliance related documentation, and conduct / complete RCA / CAPA activities\n- Oversee supplier operational/process improvement\n- Strategy and External Operations\n- Monitor and ensure achievement of desired productivity benefits from strategic initiative. Support development and maintenance of GRAAS Performance Scorecards. Develop financial and operational models to ensure achievement of business benefits. Help secure ELT approval of strategic initiatives by determining validity, expected ROI, and risk:benefit effects\n- Hands-on leadership of strategic programs and process improvements through planning and implementation. Support/drive various new outsourcing initiatives and partner with GRAAS functions\n- Support other GSEO projects driving operational excellence in alliances, mergers, and acquisitions\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nAND\n- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications Knowledge and Skills:\n- Interacting and communicating with senior executives on strategic subjects\n- Communicating and presenting clearly on strategic and business issues\n- Motivating and leading teams and projects in a global complex matrix environment\n- Excellent interpersonal, organizational, supervisory, collaboration and leadership skills\n- Experience managing cross-functional policy and business initiatives\n- Experience implementing business change\n- Crating and updating financial modeling and business value forecasting\n- Knowledge of strategic management, performance improvement , and change management models\n- Extensive knowledge of continuous improvement methodologies\n- Proficiency in anticipating and resolving problems\n- Understanding of information technology and R&D systems including safety and regulatory technologies\n- Knowledge of process improvement methodologies\n- Knowledge of project management tools and methodologies\n- Experience managing and working with various vendors\n- Knowledge of communications tools and processes (SharePoint)\n- Strong computer literacy, including word processing, presentation, spreadsheet, project and web products\n- Experience in life sciences or medically related field: knowledge of the bio/pharm industry\n- Experience engaging in regulatory and safety policy development and implementation\n- Leading at a functional level and working in a global matrix environment\n- Experience working in a global environment\n\nCompetencies:\n- Leadership skills\n- Conflict management\n- Managing diversity\n- Listening\n- Managing and measuring work\n- Building effective teams\n- Problem solving\n- Ability to keep the big picture\" in mind while dealing with the details\n- Ability to envision and implement business process solutions\n- Good written and verbal communication sills\n- Relationship building skills", "date_new": "2012-04-02 23:24:51", "url": "http://www.amgen.jobs/xml/27593239/job", "country": "United States", "company": "Amgen", "title": "Sr Mgr GRAAS Operations (Strategy and External Operations)", "reqid": "14575BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27593239}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 14628BR\nJob Posting Title Sr Biopharmaceutical Rep, Inflammation - Green Bay, WI\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Wisconsin\nLocation (City) Field Based\nAmgen Job Description Territory \u2013 #33408 Green Bay, WI covering \u2022 Northern WI and the Upper Peninsula of MI including these cities Rhinelander, Marinette, De Pere, Appleton, Manitowoc, Menasha, Neenah, Oshkosh, Green Bay, Wausau, Fond du Lac, Beaver Dam, Marshfield and Sturgeon Bay in WI and Marquette/Saint Francis in MI\n\nAmgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\n\nAs a Sr Biopharmaceutical Rep, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.\n\nAs a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager\nBasic Qualifications Bachelor\u2019s degree & 2 years of directly related experience\nOR\n- Associate\u2019s degree & 6 years of directly related experience\nOR\n- High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications 2+ years of sales and/or marketing experience within pharmaceutical, biotech or healthcare industries\n- Previous experience selling in the Rheumatology and/or Dermatology market.\n- Expert local knowledge in the primary care or specialty market.\n- Successful launch experience in a highly competitive market.\n- Outstanding business acumen including experience with:\n- Medicare Part B\n- Contracting\n- Managed Care or pull-through\n- Capital equipment or durable medical device sales\n- Proven strategic account management\n\nCore Competencies:\n- Planning and Organizing Work\n- Engaging Others Through Effective Communication\n- Drive to Achieve", "date_new": "2012-03-31 22:32:30", "url": "http://www.amgen.jobs/xml/27542773/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Inflammation - Green Bay, WI", "reqid": "14628BR", "state": "Wisconsin", "state_short": "WI", "location": "Field Based, WI", "uid": 27542773}, {"country_short": "ITA", "city": "Field Based", "description": "Auto req 14569BR\nJob Posting Title Product Specialist Oncology\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Italy\nLocation (City) Field Based\nAmgen Job Description The Italian affiliate Amgen Domp\u00e8 S.p.A is currently is looking to hire a Product Specialist for Oncology. The area of responsibility will be: a part of Naples and Caserta province.\n\nReporting to the Manager District Sales (Campania) he/she will be responsible for:\n\u2022 Maximizes sales of Amgen\u2019s products in territory\n- Achieves sales targets\n- Delivers key messages\n- Collaborates with manager to implement agreed points of action in line with marketing strategy\n- Identifies and establishes high quality customer relationships and internal collaboration\n- Knows in-depth knowledge of the product(s), market , stakeholders and competitors\n- Works within agreed budgets\n- Lives the Amgen Value\n\nKey Activities:\n\u2022 Collaborates with manager to develop and implement territory points of action (POA) and key account plans. Achieve POA.\n\u2022 Evaluates progress vs. plan monthly and agrees to course corrections with manager\n\u2022 Contributes to Cluster/Territory Teams Collaborates (Medical Affairs/Key Account Manager, etc.) to agree on key account plan objectives/responsibilities\n\u2022 Engages with peers and District Manager to learn best practices\n\u2022 Demonstrates an understanding of industry and healthcare trends, of how retail practices, clinics and hospitals operate.\n\u2022 Identify and gather competitive information\n\u2022 Follows through on customer commitments and requests in a timely fashion\n\u2022 Reports customer activity in the CRM system and ensures customer profiles are kept up-to-date\n\u2022 Demonstrates an understanding of Amgen Performance 4 selling platform to satisfy customer and Amgen needs\n\u2022 Operates within the agreed expense budget aligned with POA priorities\n\u2022 Seeks advice and assistance to organize activities\n\u2022 Continuously develops and improves product knowledge, communication and selling skills through self-learning and active participation in agreed training programs. Drives own development\nBasic Qualifications \u2022 Scientific Academic Education or similar\n\u2022 Industry experience for at least 1 year from similar position\n\u2022 Native in Italian\n\u2022 Office Programs as Word, Excel, Outlook.\n\u2022 He/she to be resident preferably in Naples or Caserta.\nPreferred Qualifications \u2022 Knowledge in therapeutic area of Oncology/Hematology\n\u2022 Fluency in English, in written and oral communication\n\u2022 Documented successful experience from sales, preferably within larger Pharmaceutical companies\n\u2022 Experience in CRM tools\n\nWe will also consider candidates with less experience but with high potential to grow and learn quickly within this great opportunity at Amgen.", "date_new": "2012-03-30 04:58:27", "url": "http://www.amgen.jobs/xml/27508347/job", "country": "Italy", "company": "Amgen", "title": "Product Specialist Oncology", "reqid": "14569BR", "state": null, "state_short": null, "location": "Field Based, ITA", "uid": 27508347}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14301BR\nJob Posting Title Mgr Manufacturing\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful candidate will be leading a team of experienced manufacturing associates responsible for downstream purification operations to manufacture clinical GMP drug substance.\nThe manager will champion a safe and compliant production environment through on the floor presence.\nThe manager will be an active participant in continuous improvement programs and will translate them onto the manufacturing floor.\n\n\nResponsibilities include:\n\u2022 Selection, training, oversight, performance evaluations, staff relations and development of staff.\n\u2022 Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities.\n\u2022 Ensures standard operating procedures are accurate for executing unit operations, batch record review is completed accurately meeting disposition timelines, and non conformances are initiated and closed with right the first time documentation.\n\u2022 Utilizes appropriate systems for job duties (SAP, QMTS, and LIMS etc.).\n\u2022 Interacts with business partners and internal & external audit teams including regulatory agencies as directed.\n\u2022 Identifies and implements process and safety improvements and assists in the introduction of new products in the facility and new technology.\n\u2022 Interacts with business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission, and quality investigations.\n\u2022 Ability to communicate production floor and project work at different levels of management.\n\u2022 Ability to elevate to sr. and executive management critical and impactful to the business floor events.\n\u2022 Technically competent to make processing decisions. Ability to troubleshoot and perform initial assessment to events that have the potential to impact product quality.\n\u2022 Flexibility to perform shift work (day, swing, and grave shift) as dictated by business needs.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nAND\n\u2022 Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Bachelor's Degree in Life Sciences or Engineering.\n\u2022 Minimally 5 years of related manufacturing experience.\n\u2022 More than 3 years experience in a production floor lead or manager role.\n\u2022 Mechanical ability/expertise coupled with a solid understanding of downstream processes.\n\u2022 Ability to understand analytical methods in the manufacturing areas.\n\u2022 Demonstrated technical writing ability.\n\u2022 Demonstrated project management and presentation skills.\n\u2022 Demonstrated experience with continuous improvement methodologies.", "date_new": "2012-03-28 21:29:29", "url": "http://www.amgen.jobs/xml/27464087/job", "country": "United States", "company": "Amgen", "title": "Mgr Manufacturing", "reqid": "14301BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27464087}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14589BR\nJob Posting Title Regulatory Writing Sr Mgr\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The purpose of this group is to prepare scientific and regulatory documents that comply with global regulatory standards. This position could be located in Thousand Oaks California, South San Francisco California, or at a remote home office.\n\nJob Summary: Prepare and oversee the development of scientific and regulatory documents and oversee senior management approval of these documents. Serve as functional area lead on product teams. Train and mentor medical writers and manage the work of GRW staff. Assist with hiring and departmental governance and with resourcing therapeutic areas and project teams.\n\nKey Activities:\n- Independently write clinical study reports, Investigator Brochures, Summaries of Clinical Efficacy, Summaries of Clinical Safety, Summaries of Clinical Pharmacology, Summaries of Biopharmaceutics, Clinical Overviews, Tables of All Studies, briefing documents, Risk Management Plans, and Response to regulatory questions\n- Prepare and manage the development of other regulatory documents and CTD sections, as appropriate (Modules 2, 3, 4 and 5 for CTD, Risk Management Plans, Responses to regulatory agency questions, protocols, statistical analysis plans, FIH documents)\n- Formally review and approve all regulatory documents\n- Serve as the functional area representative and lead on product teams (ie, GDT, GCST, GRT)\n- Provide functional area input for Global Regulatory Plans, Global Development Plans, and team goals\n- Responsible for study timelines for regulatory documents\n- Participate in development of regulatory submission strategy\n- Manage medical writers (includes career development, conducting performance reviews, providing coaching and guidance)\n- Identify, assess, and oversee individual contractors, freelance, and temporary writers\n- Keep abreast of professional information and technology through literature, symposia, and conferences\n- Participate in departmental and cross-departmental initiatives\n- Provide innovation for improving departmental processes\n- Provide expertise and guidance on document design and principles of good medical writing to the department and product teams\n- Work with medical writers to establish project priorities\n- Oversee all decisions made by reports\n- Assist with budget\n\nBasic Knowledge and Skills:\n- Experience reading, understanding, and applying regulations to constantly changing\n- Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment\n- Experience understanding and interpreting data/information and its practical application\n- Excellent written/oral communication skills and attention to detail\n- Strong time and project management skills\n- Negotiating skills\n- Perseverance with a drive for results\nBasic Qualifications - Doctorate degree and 2 years of directly related experience\nOR\n- Master's degree and 6 years of directly related experience\nOR\n- Bachelor's degree and 8 years of directly related experience\nOR\n- Associate\u2019s degree and 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - 8+ years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs)\n- Advanced knowledge of scientific/technical writing and editing\n- Advanced knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery\n- Understanding and application of principles, concepts, theories and standards of scientific/technical field\n- Knowledge of management skills and supervising the work of others\n- Understands the core business process and purpose of the functional area in Amgen's commercialization process\n- Strong Leadership in a team environment\n- Strong negotiator\n- Mentoring, training and directing others\n- Developing and delegating to direct reports with a drive for results", "date_new": "2012-03-28 21:29:19", "url": "http://www.amgen.jobs/xml/27464082/job", "country": "United States", "company": "Amgen", "title": "Regulatory Writing Sr Mgr", "reqid": "14589BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27464082}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13504BR\nJob Posting Title Sr Mgr Manufacturing - Vial Fill\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Manager Manufacturing - Vial Fill\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will report to the Director of Manufacturing. The ideal candidate will provide strong management and leadership in the Manufacturing \u2013 vial fill facility.\n\nKey Responsibilities:\n\n\u2022 Manage the Vial Fill Manufacturing Facility department.\n\u2022 Lead in the development of long range planning (LRP) to maintain the highest level of productivity.\n\u2022 Lead in the development of Manufacturing\u2019s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.\n\u2022 Develop, maintain, and justify the departments\u2019 budgets.\n\u2022 Responsible for ensuring that all manufacturing is carried out under GMP conditions and in a safe working environment.\n\u2022 Support the plant in the project approval, prioritization, and implementation process.\n\u2022 Develop metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based on the benchmarking data.\n\u2022 Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the manufacturing department.\n\u2022 Assure the appropriate level of training is undertaken for all levels of the manufacturing syringe organization which may involve developing training material.\n\u2022 Responsible for attaining and improving site based metrics targets.\n\u2022 Responsible for recruiting talented staff into the facility and setting standards for their performance.\n\u2022 This position will need to complete some travel to the other Amgen sites over the next two years.\n\n* Other functions may be assigned.\nBasic Qualifications Basic Qualifications\n\n\u2022 Typically 8+ years of experience in facilities management position. With typically 4+ years experience supervising technical staff\n\u2022 Bachelor\u2019s Degree or combination of education and/or years of experience.\nPreferred Qualifications Preferred Qualifications\n\n\u2022 Knowledge of conflict resolution\n\u2022 Ability to partner with other departments.\n\u2022 Analytical problem solving.\n\u2022 Considerable Organization skills.\n\u2022 Experience in coaching, mentoring and counselling.\n\u2022 Ability to deal with and manage change.\n\u2022 Ability to set goals.\n\u2022 Knowledge of applicable regulatory guidelines\n\u2022 Ability to use company compensation system including mentoring lower management levels when required.\n\u2022 Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-03-28 21:28:53", "url": "http://www.amgen.jobs/xml/27464075/job", "country": "Ireland", "company": "Amgen", "title": "Sr Mgr Manufacturing - Vial Fill", "reqid": "13504BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 27464075}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14171BR\nJob Posting Title Exec Dir Business Analysis & Info\nCareer Category Marketing\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description KEY RESPONSIBILITIES\nFunctional Responsibilities\n\u2022 Lead and staff a team a team in designing and developing tools for market mix and ROI analytics on promotional investments including field force detailing, physician relationship marketing campaigns, digital media and direct to consumer advertising across the Amgen portfolio of brands.\n\u2022 Utilize understanding of pharmaceutical industry and decision support science tools to create a department vision and develop effective recommendations on promotional investments for the organization.\n\u2022 Serve as an advocate and drive use of the appropriate performance metrics and action standards required to assess value of promotional investments, and lead team in developing a management dashboard for continuous measurement of key activities across business units.\n\u2022 Develop and manage department budget and adhere to Amgen financial and budgetary policies and procedures.\n\u2022 Review bench strength of present organization and take necessary steps to ensure necessary talent is available and being developed. Recruit, select and promote people to create a diverse talent pool. Serve as a role model and mentor.\nCompany-wide Responsibilities\n\u2022 Influence and facilitate decision making with a broad range of internal stakeholders including Sales and Commercial VPs, Finance, Business Analysis & Insights, Information Systems and Executive management on promotional investment decisions and business requirements.\n\u2022 Partner with Business Units and Finance executives to drive increased rigor in decision making through systematic evaluation of all key promotional tactics and structured problem solving approach.\n\u2022 Partner with Direct to Consumer team to develop approach for measurement of social media and continuous loop marketing.\nExternal Responsibilities\n\u2022 Develop mutually beneficial alliances with key strategic vendors to create and adapt the necessary tools for decision support modeling. Continuously evaluate vendors and their deliverables to ensure that they are delivering optimal value to Amgen and are aligned with Amgen compliance policies.\n\u2022 Collaborate with external vendors and team to develop test/control design for promotional experiments (e.g. inside sales team, DTC test markets) and provide competitive business insights and recommendations to key stakeholders.\n\u2022 Represent Amgen within the industry on management science and decision support function (Management Science Institute; key vendor customer summits).\n\u2022 Develop mutually beneficial relationships with external suppliers (ZS Associates; MuSigma; Impact RX).\nBasic Qualifications ? Doctorate degree & 6 years of directly related experience\nOR\n? Master\u2019s degree & 10 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 12 years of directly related experience\nAND\n? 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications PROFESSIONAL EXPERIENCE / QUALIFICATIONS\n\u2022 Functional Experience: Minimum 7-10 years (ideally more) of demonstrated experience in operations research; applied mathematics; statistics; economics or a related discipline. The ideal candidate will have not only utilized these tools but will have also played a lead role in developing and implementing the required processes, tools, and techniques.\n\u2022 Industry Experience: The candidate should have experience in an industry and company which has placed a premium on applying deep analytical rigor to the analysis of marketing and sales investments. This experience does not need to have come from the life sciences industry, rather leading-edge experience in consumer, financial services, technology, and/or other industry sectors where this skill is well-developed will be most valued. Knowledge of pharmaceutical data sources would be a plus.\n\u2022 Leadership Experience: Excellent leadership, interpersonal, organizational and supervisory skills. Experience leading teams and projects in a globally complex matrixed environment.\n\u2022 Functional Skills: Deep knowledge of decision support models for promotional ROI, market mix and sales force optimization. Knowledge and expertise in digital media measurement highly desirable.\n\u2022 Business Skills: Proven track record in leading business recommendations and decisions through the application of management science techniques. Experience implementing business change.\n\u2022 Communication Skills: Excellent written and verbal communication and analytic skills. Experience interacting with and influencing senior executives on strategic initiatives related to promotional investments.\n\nEDUCATION\n\u2022 Masters degree (MS or MBA) with focus on operations research; applied mathematics; statistics; economics or a related discipline.", "date_new": "2012-03-28 21:27:45", "url": "http://www.amgen.jobs/xml/27464063/job", "country": "United States", "company": "Amgen", "title": "Exec Dir Business Analysis & Info", "reqid": "14171BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27464063}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14277BR\nJob Posting Title Director Information Systems - Enterprise Application Services (Web & Collaboration Services)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Director Information Systems role leads the Web and Collaboration Services Center of Excellence in Enterprise Application Services reporting to the VP IS, Enterprise Application Services. Collaborates with key stakeholders in the business and IS to create, manage and deliver the organization\u2019s web, collaboration and social media strategy. Responsible for the delivery of all IS aspects of the strategy incorporating key business, technology and security drivers to ensure maximum business value.\n\nJob Responsibilities:\n\u2022 Provide strategic leadership and direction for the adoption of web 2.0 mobile and social media networking practices and technology.\n\u2022 Collaborate with business and IS stakeholders to establish effective business sponsorship and governance of key collaboration and digital platforms such as MyAmgen and Amgen.com as well as for Amgen external web platforms and associated websites.\n\u2022  Develop, execute and maintain IS mobile and web strategy aligned with business growth and productivity drivers.\n\u2022 Responsible for day to day operations and maintenance of the global web and collaboration platforms.\n\u2022 Manage platform strategy and associated technology lifecycle including regular maintenance and enhancement releases, lifecycle upgrades and continuous improvements to the user experience.\n\u2022 Responsible for the development of effective partnerships with vendors and outsourced providers to ensure enterprise class service delivery related to web and collaboration platforms.\n\u2022 Work with IS Information Security and Enterprise Architecture to ensure security of digital platform and applications.\n\u2022 Manage, mentor and develop enterprise web & collaboration staff to deliver the maximum value from web & collaboration services.\n\u2022 Support and contribute to Amgen\u2019s Information Management Strategy. Design and implement a sustainable content lifecycle process that implements the information management strategy in Amgen\u2019s enterprise web and collaboration platforms.\n\u2022 Collate data and produce reports related to collaboration and social media usage and adoption and present the analysis to management to demonstrate value.\n\u2022 With business stakeholders and Information Security, establish collaboration and social media usage policies and procedures for internal users.\n\u2022 Monitor trends in online community tools, trends, and applications and incorporate as appropriate into IS and business web, collaboration and social media strategies.\nBasic Qualifications Doctorate degree & 4 years of directly related experience\nOR\nMaster\u2019s degree & 8 years of directly related years\nOR\nBachelor\u2019s degree & 10 years of directly related experience\nAND\n4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications Master\u2019s degree\n\nBachelor\u2019s Degree in Engineering, Information Systems, Computer Science, Marketing or Communications\n\n12 + years experience working within information systems and supervising staff\n\nExperience deploying web, collaboration and social media platforms in large enterprises\n\nStrategic leadership experience and ability to facilitate alignment across multiple geographies\n\nExcellent oral, written and interpersonal communication skills\n\nPossess functional knowledge or some experience with HTML, knowledge of search engine optimization and tagging, etc.", "date_new": "2012-03-27 20:15:57", "url": "http://www.amgen.jobs/xml/27423885/job", "country": "United States", "company": "Amgen", "title": "Director Information Systems - Enterprise Application Services (Web & Collaboration Services)", "reqid": "14277BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27423885}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14514BR\nJob Posting Title Global Safety Sr Medical Scientist\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role provides content and technical support to the GST in the evaluation of safety data and production of GST deliverables under the supervision of the Global Safety Officer (GSO). Due to significant experience in the role from a scientific and technical perspective this role requires increased independence and leadership with less direct supervision of content driven activities by the GSO. The incumbent must be able to serve as GSO delegate for internal and potentially external Amgen meetings (Data Monitoring Committee, Ad-com representation).\n\nKey Activities:\n\nSupport Global Safety Officer (GSO) in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology\n\nResponsible for producing presentations for Product Safety Review Meetings (PSRM) and other scientific presentations under the guidance of the GSO\n\nContribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables\n\nSafety content and expertise in support of Investigator Meetings, Data Monitoring Committees and DRTs, responses to regulatory authorities, safety sections of clinical trial documents\nBasic Qualifications MD or DO degree from an accredited medical school\n\nCompletion of an accredited medical or surgical residency\nOR\nClinical experience in either an accredited academic setting or private practice (including hospital based) setting\nPreferred Qualifications Advanced Education in Nephrology strongly preferred.\n\nCurrent registered medical license\n\nBoard certified or Board eligible\n\nAccredited fellowship or clinical experience\n\nClinical experience, including training\n\nDrug safety experience", "date_new": "2012-03-27 20:15:04", "url": "http://www.amgen.jobs/xml/27423850/job", "country": "United States", "company": "Amgen", "title": "Global Safety Sr Medical Scientist", "reqid": "14514BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27423850}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 14549BR\nJob Posting Title Sr Scientist - Bioinformatician / Computational Biologist\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Washington\nLocation (City) Seattle\nAmgen Job Description The Department of Comparative Biology and Safety Sciences is looking for a highly motivated bioinformatician/computational biologist to contribute to its programs for toxicity screening and hazard identification in preclinical drug development.\n\nThe successful employee will develop and utilize a variety of analytical approaches and computational tools to help integrate and analyze high volume data sets, including omics, next-gen sequencing, mass spectrometry, and selectivity data.\n\nIn this position, the individual is expected to proactively support and lead selected projects.\n\nThe employee will be responsible for enhancing in-house bioinformatics tools and databases and developing new methodologies for complex data analysis and visualization. Data integration, management, and visualization are anticipated to be a substantial component of this job and the employee is expected to provide leadership and expertise in these areas.\n\nAn excellent team spirit, proactive attitude, and good communication skills are necessary.\nBasic Qualifications Doctorate degree & 2 years of scientific experience\nOR\nMaster\u2019s degree & 8 years of scientific  experience\nOR\nBachelor\u2019s degree & 10 years of scientific experience\nPreferred Qualifications A PhD in Bioinformatics, Mathematics, Computer Science, Physical Sciences, or related fields with 3+ year working experience in biomedical environment is required.\n\nA strong knowledge in mathematical modeling, statistical analysis, and relational databases are expected.\n\nProven track record of integrating and analyzing various types of large-scale biomedical data as well as omics data are essential.\n\nAbility to translate biological questions into computational work streams and the ability to translate the outcome of computational processes into biologically meaningful messages are highly desirable.\n\nSkills in algorithm development as well as high level scripting languages such as R, Matlab, or S+ are also expected.\n\nSoftware engineering experience in a team environment is a plus. A proven ability and willingness to work with multidisciplinary teams is essential.\n\nStrong written and oral communication skills, self-motivation, independence and leadership are required.\n\nPrior experience of drug discovery and development process and knowledge of technology platforms are preferred, but not required.", "date_new": "2012-03-27 20:14:32", "url": "http://www.amgen.jobs/xml/27423835/job", "country": "United States", "company": "Amgen", "title": "Sr Scientist - Bioinformatician / Computational Biologist", "reqid": "14549BR", "state": "Washington", "state_short": "WA", "location": "Seattle, WA", "uid": 27423835}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14519BR\nJob Posting Title Senior Manager, Pipeline Strategy and Portfolio Management\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Senior Manager is responsible for partnering cross-functionally to support portfolio management and pipeline strategy development processes across Amgen\u2019s commercialization process.\n\nResponsibilities\n\nProduct valuation and risk analysis\n\n\u2022 Work with Product Strategy Teams (PST) to assess the value, cost, and risk of alternative development options for R&D pipeline programs to support effective stage gate decisions\n\u2022 Conduct due diligence to ensure pipeline / project valuation inputs are consistent and aligned across Development, Commercial, Finance, and Operations\n\u2022 Ensure appropriate integration of cost, risk, and return inputs into key product development decisions at the therapeutic area and portfolio governance level\n\u2022 Employ decision analysis and probabilistic modeling methods to highlight key trade-offs across strategic alternatives and support recommendations for optimal strategy choice\n\u2022 Ensure Product Strategy Teams (PST) can effectively integrate and communicate the value, cost, and risk implications of product development alternatives and recommendations\n\nPortfolio management and analysis\n\n\u2022 Support development of TA strategy by conducting internal pipeline assessments, forecasting portfolio productivity and throughput, and identifying potential pipeline gaps\n\u2022 Support the pan-Amgen portfolio prioritization process by leveraging relevant measures of cost, risk, and value to analyze TA portfolio alternatives\n\u2022 Collaborate with commercial Finance to ensure Long Range Plan revenue submission is consistent with latest approved probability adjusted forecasts\n\u2022 Interface with key PST members to ensure project and pipeline assumptions are aligned with current thinking and recorded / captured appropriately\n\u2022 Interface with other members of the Pipeline Strategy and Portfolio Management team to ensure the TA pipeline is accurately represented in portfolio reports, historical pipeline metrics, and forward looking resource estimates\n\nAnalytical frameworks and foundations\n\n\u2022 Drive improvements and enhance consistency in Amgen\u2019s product valuation, methods, policies, and tools, integrating more decision analysis methods and creative analytical approaches\n\u2022 Support evolution of Amgen\u2019s portfolio management framework through effective process design, problem solving, and change management efforts\n\u2022 Support improved application of valuation and portfolio management concepts across Amgen through informal coaching and formal training and development\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Advanced degree in science or business\n\u2022 7 years or more in biotech / pharma or life sciences management consulting doing project portfolio management, strategic planning, resource management, decision sciences, and / or financial planning\n\u2022 Good understanding of clinical development, regulatory issues, and market dynamics in the pharmaceutical and biotech industry\n\u2022 Able to foster trusted relationships with key partners including Therapeutic Area leadership, product teams, Finance, etc\n\u2022 Demonstrated ability to apply decision analysis methods and financial valuation to complex product development and portfolio decisions\n\u2022 Prior experienced developing stochastic forecasting models (e.g. monte carlo, real options, etc)\n\u2022 Comfortable with ambiguous work assignments and experience managing change in a complex, matrix organization\n\u2022 At least 5 years in biotech / pharma or life sciences management consulting doing project portfolio management, strategic planning, resource management, decision sciences, and / or financial planning\n\u2022 Excellent analytical and presentation skills\n\u2022 Knowledge of advanced modeling and forecasting methods and tools\n\u2022 Excellent team work and ability to work effectively across functions and with partner organizations to meet deliverables", "date_new": "2012-03-26 21:52:35", "url": "http://www.amgen.jobs/xml/27400880/job", "country": "United States", "company": "Amgen", "title": "Senior Manager, Pipeline Strategy and Portfolio Management", "reqid": "14519BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27400880}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14453BR\nJob Posting Title Sr Associate IS Bus Sys Analyst\nCareer Category Information Systems\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Partner with Quality, Operational Excellence, and Environmental Health and Safety functions managing their overall IS needs. Manage the ongoing expectations and prioritization of functional area requirements. Serve as business analyst engaging with key stakeholders to develop strategic vision, implement process improvements and manage projects within the IS portfolio.\n\nKey Responsibilities:\n\n\u2022 Gather business requirements, provide planning, design review, and lead testing during the implementation/deployment of solutions, enhancements and new releases\n\u2022 Communicate and manage the client area expectations in the delivery of IS solutions\n\u2022 Participate in cross-organizational and cross-departmental meetings to represent both business and IS stakeholders\n\u2022 Coordinate technical resources in the delivery of IS services\n\u2022 Participate in the implementation and/or communication efforts for new programs and processes\n\u2022 Ensuring that IS technologies and processes will be deployed and supported to meet business needs and objectives\n\u2022 Not only recommend appropriate technology, but also provide the organizational understanding to adapt recommendations that can be effectively implemented and adopted\nBasic Qualifications \u2022Master\u2019s degree OR\n\u2022Bachelor\u2019s degree & 2 years of directly related experience OR\n\u2022Associate\u2019s degree & 6 years of directly related experience OR\n\u2022High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications \u2022Bachelor's degree in Engineering, Information Systems or Computer Science with 2 plus years related experience required. Advanced degrees and/or Life Sciences experience preferred.\n\u2022Past experience working in a global environment\n\u2022Knowledge of the pharmaceutical industry and current approaches to GxP computer related systems\n\u2022Experience scoping, defining, planning, implementing and documenting business opportunities\n\u2022Client management skills - ability to work with internal business functions to understand their business processes, manage scope of work expectations and suggest / recommend IS solutions\n\u2022Ability to function in a matrix team environment\n\u2022Experience with prototyping approaches to software development\n\u2022Experience with system design, configuration and business processes in a drug manufacturing environment\n\u2022Knowledge of technical diagrams, process flowcharting and project management using MS Office applications, including MS Project and MS Visio and similar applications\n\u2022Proven delivery of a completed system or application as part of a project or developer\u2019s team, preferably with an industry partner\n\u2022Knowledge of Software Architecture and the structure of software solutions\n\u2022Ability to master, with minimal support, new IS technologies and processes\n\u2022Effective written and verbal communication skills\n\u2022Excellent analytical, problem-solving, business analysis and decision-making skills\n\u2022Able to multi-task and stay focused on priorities in a fast paced environment to meet deadlines, including the ability to be comfortable and function effectively in an environment of ambiguity\n\u2022Strong team player who is able to collaborate with colleagues on complex tasks and can use influence to achieve the required results\n\u2022Understanding of business intelligence and reporting technologies\n\u2022Ability to participate/support efforts being run across multiple sites to ensure solutions satisfy local requirements\n\u2022Should have experience with Enterprise systems, validation, testing and change control\n\u2022Understanding of the ITIL process framework and outsourced resource support models\n\u2022Knowledge of Rational Unified Process (RUP) and/or experience with formal SDLC project methodologies\n\u2022Knowledge of IS quality and compliance policies, SOPs and associated documents.\n\u2022Position may require 10-20% travel", "date_new": "2012-03-26 21:52:14", "url": "http://www.amgen.jobs/xml/27400867/job", "country": "United States", "company": "Amgen", "title": "Sr Associate IS Bus Sys Analyst", "reqid": "14453BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27400867}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13996BR\nJob Posting Title Principal Scientist - Medical Sciences \u2013 In Vitro Diagnostics\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description As a result of the ongoing success of Amgen\u2019s comprehensive biomarker programs a new In Vitro Diagnostics (IVD) Group has been established in Medical Sciences. The IVD group is responsible for the transition of an exploratory biomarker to an IVD, working with other functions within Amgen to identify the diagnostic partner.\n\nThe Principal Scientist is responsible for leading cross-functional teams required to successfully manage and execute these partnerships through not only regulatory approval in multiple jurisdictions but also its life cycle as a companion to Amgen\u2019s therapeutic.\n\nThis Principal Scientist will be a highly motivated individual experienced in diagnostic development of histochemical and cytochemical analysis and/or molecular genetic analyses. The employee would be experienced in the use of these types of diagnostic devices in laboratory practice as well as demonstrated expertise in and knowledge of regulatory submissions of in vitro diagnostic devices. The incumbant will also have excellent communication skills across a broad range of stakeholders being able to influence decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.\nBasic Qualifications \u2022 Doctorate degree & 5 years of scientific experience\nOR\n\u2022 Master\u2019s degree & 12 years of scientific  experience\nOR\n\u2022 Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications \u2022 5-10 years experience in industry\n\u2022 PhD\n\u2022 A demonstrated background integrating data from multiple sources and identifying critical process variables.\n\u2022 A solid record of establishing and reviewing complex plans for multiple projects or activities. This includes planning resource allocation and distribution and identifying contingency plans.\n\u2022 The ability to implement project plans comprehending resource, budget, facility and regulatory requirements to meet project goals.", "date_new": "2012-03-23 21:26:45", "url": "http://www.amgen.jobs/xml/27358480/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - Medical Sciences \u2013 In Vitro Diagnostics", "reqid": "13996BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27358480}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 14343BR\nJob Posting Title IS Business Analyst\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nAmgen Job Description The Information System (IS) Business Analyst is a functional analyst with client facing and supply responsibilities. This role will ensure a successful IS implementation by evaluating the principal business needs, challenging technical solutions and facilitating the change process.\nThe person taking this role will be responsible for International OTC processes within a global context.\nThis role will work in close coordination with other members of the Operations and SAP Center of Excellence teams in Europe and US.\nThe Business Analyst will participate in gathering requirements, design development and the review of SAP Configuration.\n\nPrimary Focus/ General Accountability:\n? This role is responsible for leading and developing the further implementation of OTC processes (both SAP & non-SAP). This could involve working within the EDI space, so knowledge of this along with other interfaces to external 3rd parties is critical.\n? Ongoing maintenance and configuration activities related to this space\n? Lead the development, configuration and system integration for the implementation of OTC processes in a global environment.\n? Act as in-house OTC subject matter expert and support ongoing activities.\n? Provide 3rd level support for SAP OTC/BAR users.\n? Lead / Participate in OTC change requests and projects.\n? Analyze functional requirements and drive the development of detailed functional / configuration / systems specifications and documentation.\n? Responsible for completeness and quality of functional design.\n? Provide high-level estimates for design and implementation effort.\nBasic Qualifications ? Minimum 3+ years hands on experience in the SAP OTC implementation and configuration, specific knowledge on SD and other products within this space (XPI, iDocs and Xi).\n? Must have a strong working knowledge of SAP SD\n? Experience in global operating SAP OTC implementations.\n? Experience in Business Process Analysis & Design to make the connection between SAP and 3rd parties\u2019 distribution systems.\n? Experience in testing and production delivery.\n? Experienced in functional and technical specification development.\n? Experienced in troubleshooting and resolving SAP functional problems.\n? Understanding of complex interfaces between different SAP systems.\n? Bachelor or Master degree, preferably in Commerce/Business, Engineering or Computer Science.\n? Strong analytical skills.\n? Strong teamwork skills.\n? Strong written and oral communication skills.\n? Experience working in a regulated industry (Biotech or Pharmaceutical Industry preferred).\nPreferred Qualifications Knowledge\n- Knowledge of computer validation concepts in compliance with FDA/EMEA and other regulatory requirements.\n\nExperience\n- Systems Design Analysis\n- Network Technologies\n- Web Technologies\n- Computer Systems and Security", "date_new": "2012-03-22 18:52:24", "url": "http://www.amgen.jobs/xml/27320715/job", "country": "Netherlands", "company": "Amgen", "title": "IS Business Analyst", "reqid": "14343BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 27320715}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14509BR\nJob Posting Title Engineer - Packaging\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Packaging Engineer\n\nAmgen Job Description Packaging Engineer - Process Development\n\nThis position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components, the associated systems such as documentation, equipment and processes.\n\nKnowledge of primary and secondary packaging systems and processes, packaging equipment, components and packaging processes, material science and quality system is essential to the position.\nThe position will leverage organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\n\nThis position is responsible and accountable for the following:\n\n1) Evaluation, recommendation and selection of primary and secondary packaging materials, equipment , and vendors\n2) Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials / equipment.\n3) Write Technical Specifications, SOP\u2019s and Bill of Materials\n4) Representing Process Development in Drug Product and Global Operation Teams as required\n5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes\n6) Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes\n7) Ensures cGMP and regulatory compliance are met at all times\n8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes\n9) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.\n10) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems in a timely manner.\n11) Excellent problem solving and RCA skills. Excellent report writing skills.\n12) Support the NPI process\n13) Effectively review and close out non conformances by CAPA\n14) Participate in FAT, SAT\n\nDemonstrated Competencies/Skills:\n1) Independent thinker with demonstrated skills working in teams or leading project teams\n2) Strong Interpersonal and communication skills\n3) Ability to multi-task and manage tight timelines\n4) Excellent report writing skills\n5) Proven problem solving skills and indepth knowledge of problem solving methodologies\n6) Knowledge of Regulatory environment\n7) Flexible and adaptive \u2013 this position will involve travel and shift work.\nBasic Qualifications Basic Qualifications \u2022 Degree / diploma in engineering discipline with 5 + years relevant pharmaceutical packaging experience\nOr\n\u2022 Degree / diploma in packaging technology / materials sciences with 5 + years relevant pharmaceutical packaging experience", "date_new": "2012-03-22 18:49:02", "url": "http://www.amgen.jobs/xml/27320620/job", "country": "Ireland", "company": "Amgen", "title": "Engineer - Packaging", "reqid": "14509BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 27320620}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 14252BR\nJob Posting Title Principal Scientist - Drug Development for Metabolic Diseases\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nAmgen Job Description We are seeking a highly motivated individual to be one of the leaders in Amgen San Francisco engaged in drug development related to metabolic diseases.\n\nThis incumbant will be expected to interact seamlessly and collaboratively with project leaders in metabolic and other functional areas to help guide efforts to discover novel therapeutics.\n\nThe successful incumbant must have exceptional scientific leadership, managerial and verbal and written communication skills, and be able to function optimally in a team-based/collaborative environment.\n\nAdditional the incumbant will have the ability to critically evaluate data and a thorough knowledge and understanding of the drug development process.\nBasic Qualifications - Doctorate degree & 5 years of scientific experience\nOR\n- Master\u2019s degree & 12 years of scientific  experience\nOR\n- Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications Ph.D. in Life Sciences, Pharmacology, or related discipline.\n\n7+ years of relevant work experiences following post-doctoral training with world-class expertise in metabolic diseases for performing hands-on experiments in academia or industry\n\nExperience in the pharmaceutical or biotech industry\n\nOutstanding track record of successful research, including publication in peer-reviewed journals and patent filings\n\nStrong back ground in cell biology, various cell culture systems, expression systems, molecular biology, biochemical assay development, and good understanding of relevant in vivo models\n\nAbility to act as a scientific liaison and project facilitator and expertise in database management and project tracking\nGood written and oral communication skills\n\nGood organizational and multi-tasking skills", "date_new": "2012-03-21 18:37:30", "url": "http://www.amgen.jobs/xml/27297592/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - Drug Development for Metabolic Diseases", "reqid": "14252BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 27297592}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14194BR\nJob Posting Title Training and Development Manager\nCareer Category Training\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description The Training and Development Manager will be responsible for developing partnerships with key clients while influencing and establishing operating standards and practices.\n\nTo be successful in this role you will need to complete the following:\n\n\u2022 Under minimal supervision, partners with the client to apply human performance theory and needs\nanalysis skills to analyze performance issues and identify solutions that support business\nneeds.\n\u2022 When a training need is identified, can utilize instructional design and adult learning\nmethodologies to design and develop solutions in a variety of delivery formats.\n\u2022 Manages assigned projects.\n\u2022 Works with internal clients to manage their curricula and assignments and ensure all training\nmaterials are integrated with Amgen\u2019s learning management system per defined business processes.\n\u2022 Supports the gathering and evaluation of metrics that ensure the effectiveness of performance\nsolutions and training materials.\n\u2022 Serves as an internal client\u2019s first point of contact for performance and training questions.\n\u2022 Leads global training forum for client function and represents client during Operations global\ngovernance and prioritization processes.\n\u2022 Writes instructional materials, leader\u2019s guides, etc, and able to modify existing material.\n\u2022 Develops and conducts Train-the-Trainer classes/support as needed.\n\u2022 Works with audit response teams to ensure appropriate actions are taken.\n\u2022 Provides proactive strategic planning to client regarding future performance needs and global\ncurricula projects.\n\u2022 Serves on sustainment steering committee for applicable global programs.\n\u2022 Ensures that training content is current and reflects all technical and compliance standards.\nBasic Qualifications \u2022 Bachelors Degree or comparable professional experience in Instructional Design, Human\nPerformance Technology, Life Sciences, or Business\n\u2022 5+ years experience as a performance consultant, instructional designer, and/or curriculum\ndeveloper\n\u2022 Knowledge of adult learning theory, instructional design, performance consulting, and needs\nanalysis\n\u2022 Experience using ADDIE or other instructional design methodology in the creation of training\nmaterials\n\u2022 Experience supporting and/or creating materials for on-the-job training\n\u2022 2+ year project management (managing projects, defining scope, overseeing budget, tracking\nmilestones)\n\u2022 Travel, up to 10%\nPreferred Qualifications \u2022 2 years experience in Microsoft Word, PowerPoint, and Excel\n\u2022 Any experience with business processes surrounding the use of learning management or training\nsystems (i.e., SumTotal, ISOtrain)\n\u2022 Experience working in a regulated environment (FDA, OSHA, NRC, etc.)\n\u2022 1 year experience with Visio and MS Project\n\u2022 eLearning design experience and knowledge of online performance support tools\n\u2022 Ability to work with staff across all levels of an organization\n\u2022 Effective communication and writing skills", "date_new": "2012-03-21 18:36:06", "url": "http://www.amgen.jobs/xml/27297538/job", "country": "Ireland", "company": "Amgen", "title": "Training and Development Manager", "reqid": "14194BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 27297538}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14198BR\nJob Posting Title Sr Associate Training & Development\nCareer Category Training\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Under limited supervision, delivers training programs to support business needs. Performs on-the-job training demonstrations and coaching sessions in a learning lab or actual production environment. Conducts classroom training. Works closely with assigned client groups to assess and meet training needs.\n\n\nFUNCTIONS\n\n\u2022 Responsible for effective delivery of training to client group. Includes classroom, one-on-one,\nand on-the-job training. Could also ensure effective delivery of eLearning courses.\n\u2022 Works closely with assigned clients, in their work environment, to understand and assess\nspecific training needs.\n\u2022 Communicates client training needs to local training management.\n\u2022 Responsible for delivery of solutions to meet the specific training needs of assigned clients.\n\u2022 Responsible for effective delivery of cGMP and other regulatory training, as required by client\ngroup.\n\u2022 Delivers initial and ongoing training for new hires and transfers. Facilitates transition of new\nhires/transfer-ins from training environment to work environment.\n\u2022 Facilitates the assignment and un-assignment of training courses/modules for staff members.\n\u2022 Provides guidance to client on compliance and regulatory issues.\n\u2022 Participates and /or leads inspections activities.\n\u2022 Coaches and develops SME/ certified trainers within client area to be effective trainers.\n\u2022 Assists in review of human error\u201d-related incidents: determine need for additional or modified\ntraining interventions for affected staff.\n\u2022 May provide input into the implementation of corporate core curricula and standard learning\nprocesses.\n\u2022 May participate on global training teams as assigned.\n\u2022 May include small scale training design projects to meet local client needs.\nBasic Qualifications Master\u2019s degree OR Bachelor\u2019s degree & 2 years of of experience directly related to the job OR Associate\u2019s degree & 6 years of experience directly related to the job.\nPreferred Qualifications \u2022 Strong customer service orientation and influencing skills to work directly with client staff\nand identifying performance needs.\n\u2022 Working knowledge on computer software programs including: Word, Excel, and Power Point.\n\u2022 Works directly with client in delivering training.\n\u2022 Demonstrates understanding of Amgen\u2019s business and culture, and ability to work effectively with\nstaff at all levels\n\u2022 Technical competency commensurate with assigned area(s) of responsibility\n\u2022 Regulatory compliance competency commensurate with assigned area(s) of responsibility Skilled in\nprocess modeling and troubleshooting\n\u2022 Basic project management skills\n\u2022 Good interpersonal, group facilitation and presentation skills\n\u2022 Able to accomplish results through own work and through influencing client staff members and\nmanagement", "date_new": "2012-03-21 18:35:48", "url": "http://www.amgen.jobs/xml/27297532/job", "country": "Ireland", "company": "Amgen", "title": "Sr Associate Training & Development", "reqid": "14198BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 27297532}, {"country_short": "USA", "city": "Field Based", "description": "Auto req 14512BR\nJob Posting Title Sr Biopharmaceutical Rep, Oncology - Salt Lake City, UT\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) United States - Utah\nLocation (City) Field Based\nAmgen Job Description Territory: (#)17204 Salt Lake City, UT covering SLC, Provo and Ogden, UT\n\nAs a Senior Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products.\n\nAs a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager\n\nAmgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.\nBasic Qualifications Bachelor\u2019s degree & 2 (two)years of directly related experience\nOR\n- Associate\u2019s degree & 6 years of directly related experience\nOR\n- High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications Two+ years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries\n- Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred\n- Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred\n- Local Market knowledge\n- A Bachelor's degree in Life Sciences or Business Administration\n\nCore Competencies:\n- Planning and Organizing Work\n- Engaging Others Through Effective Communication\n- Drive to Achieve\n- Individual Leadership and Impact", "date_new": "2012-03-21 18:35:37", "url": "http://www.amgen.jobs/xml/27297523/job", "country": "United States", "company": "Amgen", "title": "Sr Biopharmaceutical Rep, Oncology - Salt Lake City, UT", "reqid": "14512BR", "state": "Utah", "state_short": "UT", "location": "Field Based, UT", "uid": 27297523}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13916BR\nJob Posting Title Global Marketing Sr Mgr, Prolia and Pipeline Assets\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Global Marketing Senior Manager will provide support to the Global Commercial Lead (GCL)\nsupporting Prolia and will ultimately support additional pipeline assets, such as AMG 785 and others.\n\nPrimary responsibilities include the development and execution of globally integrated plans, with a\nparticular focus on planning and execution of deliverables for the Global Commercial Teams (GCT) and related sub-teams. Projects focused on Prolia and Bone TA strategies are included, e.g., support for annual Global Strategy and Commercial Plans (GSPs and GCPs).\n\nThis role will report to the TA Head, Bone & Inflammation, Global Marketing.\n\nSpecific responsibilities include:\n\n1. High quality, integrated Global Commercial plans and marketing projects within programs\n2. Communication of deliverables and plan information to key stakeholders\n3. Ensuring alignment between Global Commercial and GCT plans\n4. Contributing to the development of high performing GCTs and GCT sub-teams including operating\nreviews\n5. Leading and/or participating in special department, cross-functional or team projects\n6. Applying best practice project management to Amgen\u2019s Global Marketing processes\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 MBA preferred or equivalent experience and/or training\n\u2022 Eight (8) years experience in the biotechnology, pharmaceutical industry, or other healthcare related field\n\u2022 Marketing, brand management, and/or product launch experience strongly preferred, with associated project management skills\n\u2022 Experience in leading cross-functional teams\n\u2022 Knowledge of bone or women\u2019s health therapeutic areas\n\u2022 Two (2) years of international experience gained within either an affiliate or regional marketing\norganization\n\u2022 Ability to work cross-culturally", "date_new": "2012-03-20 20:22:26", "url": "http://www.amgen.jobs/xml/27271537/job", "country": "United States", "company": "Amgen", "title": "Global Marketing Sr Mgr, Prolia and Pipeline Assets", "reqid": "13916BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27271537}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14419BR\nJob Posting Title Exec Dir Access & Reimbursement Ops\nCareer Category Marketing\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Exec Dir Access & Reimbursement Ops is a role responsible for designing, developing and leading the Access and Reimbursement Operations Center of Excellence (CoE) to deliver on corporate and departmental goals. This position provides strategic, operational, and regulatory guidance for development and execution of product/Business Unit access & reimbursement services strategy. Additionally, this position has responsibility for commercial A&R operations platform and outsourced supplier management, including development of critical success factors, supplier metrics and continuous improvement efforts across all brands. Individual will have budget and forecasting responsibility for all commercial call centers.\n\nKey components of the role include the following:\n\nAccess & Reimbursement Operations\n\u2022 Owns commercial Contact Center operations and the execution of brand strategies\n\u2022 Cross-functionally integrates to provide SME input into brand/ Business Unit strategies and operational plans to enable top line growth\n\u2022 Provides leadership across the organization to ensure Contact Centers are optimally utilized and outsourced partners are managed appropriately and cost effectively\n\u2022 Directs the design, implementation, and ongoing improvement of all technology and telephony used by outsourced provider to ensure timely, accurate and cost efficient provision of access and reimbursement services\n\nCustomer Focus\n\u2022 Leads Amgen commercial teams cross functionally in designing, developing and maintaining customer service standards that improve Amgen\u2019s customer service standards.\n\u2022 Utilize best practices from industry, across Business Units, from R&D, etc. to enhance customer service and contact center program. As a thought leader, this individual will share the customer experience\u201d with other Amgen leaders and lead change that results from enhanced customer knowledge.\n\nManagement\n\u2022 Will direct A&R operations CoE staff and have dotted line relationships with Business Unit Access Teams in support of strategic plan.\n\u2022 Will own outsourced relationship for commercial Contact Center and will lead operational and annual strategic business reviews.\n\u2022 Will develop a cohesive and effective team to manage outsource partners, integrate with the business units and nurture a collaborative spirit that allows for team and Amgen success.\n\u2022 Develops a working environment that supports all aspects of the Amgen values.\nBasic Qualifications \u2022 Doctorate degree & 6 years of directly related experience, or\n\u2022 Master\u2019s degree & 10 years of directly related experience, or\n\u2022 Bachelor\u2019s degree & 12 years of directly related experience, AND\n\u2022 6 years of direct managerial and/or leadership experience\nPreferred Qualifications \u2022 MBA or other graduate level degree\n\u2022 In-depth experience leading Contact Centers, preferably in the healthcare industry\n\u2022 In-depth experience in Access and Reimbursement in the biopharmaceutical industry\n\u2022 Experience in managing technical support operations\n\u2022 Experience in managing out sourced providers in a regulated industry\n\u2022 Deep knowledge of current contact handling technology and its deployment\n\u2022 Experience in evaluating and implementing cutting edge technologies within Access and Reimbursement Operations\n\u2022 Successfully led organizational contact center change to adapt to corporate challenges", "date_new": "2012-03-20 20:18:35", "url": "http://www.amgen.jobs/xml/27271289/job", "country": "United States", "company": "Amgen", "title": "Exec Dir Access & Reimbursement Ops", "reqid": "14419BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27271289}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14399BR\nJob Posting Title Category Sr Mgr\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Category Senior Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Senior Manager will be responsible for business case development, strategic sourcing and ongoing supplier management for assigned categories that support Development.\n\nWorking within a matrix environment, the Category Senior Manager is responsible for applying in-depth disciplinary knowledge, business acumen and subject matter expertise to deliver strategic sourcing objectives. The Category Sr Manager employs category management, project management and change management techniques to effectively deliver strategic sourcing initiatives. The Category Sr Mgr leads the category management process, which includes conducting business opportunity analysis, make/buy analysis, data analysis, requirements gathering, development and execution of RFx, sourcing strategy development and implementation, contract development, negotiation and management, supplier on-boarding, and implementation and support ongoing supplier governance. Leading project and program teams accountable for successful source and supplier development and management is fundamental to the role.\nBasic Qualifications -Doctorate degree & 2 years of directly related experience\nOR\n-Master\u2019s degree & 6 years of directly related experience\nOR\n-Bachelor\u2019s degree & 8 years of directly related experience\nOR\n-Associate\u2019s degree & 10 years of directly related experience\nOR\n-High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications -MBA preferred\n-5+ years of Strategic Sourcing experience\n-3+ years Biotech/Pharmaceutical experience\n-7+ years experience in a complex business environment\n-Certified Purchasing Manager (CPM), Project Management Professional (PMP), and/or Green/Black Belt Six Sigma certification\n-Category sourcing experience in Research and Development categories such as scientific services, or laboratory support services\n-General understanding of Biotech/Pharmaceutical practices and standards\n-In-depth knowledge of the principles, methods and practices as they relate to strategic sourcing, project management and/or change management\n-Experience contributing to the development of a category strategy with business partners\n-Ability to translate company goals into category priorities, strategy and direction\n-Ability to work in a complex business environment\n-Applies data gathering and analytical skills to drive fact based decision making\n-Develop innovative and creative outputs based on insightful interpretation and analysis\n-Ability to define opportunities and risks and facilitate selection of appropriate alternatives\n-Ability to proactively identify roadblocks and effectively identify and execute solutions\n-Plan, track and report progress of sourcing related initiatives\n-Work independently to establish initiative timeline, managing deliverables and ability to appropriately identify and escalate issues when needed\n-Ability to build productive internal relationships and strategic supplier partnerships\n-Demonstrated negotiation, conflict resolution and stakeholder management capabilities\n-Strong oral and written communication skills and excellent organization and planning skills\n-Demonstrated success with strategically sourcing services that support a biopharma research organization", "date_new": "2012-03-20 20:14:07", "url": "http://www.amgen.jobs/xml/27270923/job", "country": "United States", "company": "Amgen", "title": "Category Sr Mgr", "reqid": "14399BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27270923}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14408BR\nJob Posting Title Reimbursement Director, Global Value and Access\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Participate as a member of Amgen's Global Pricing and Payer Planning Team. This team is responsible for strategic planning to support value and access for all Amgen molecules in development, beginning in Phase I-II and extending throughout commercialization across the Amgen portfolio. This includes lifecycle planning and access support for our inline molecules. Additionally, the team is responsible for global strategic pricing, including recommendations for global price bands and launch sequence.\n\nEach global payer plan integrates coverage and reimbursement, pricing, value evidence, and policy into the development of a strategic plan that supports the overarching commercial objectives and links to the clinical attributes of the molecule. This plan elucidates and communicates the strategies and tactics to secure and maintain access throughout the lifecycle of a specific molecule.\n\nEach Director will serve as the Global Payer Leader and represent payer needs on the multi-disciplinary Product Strategy Team for one or more molecules. He/she will also lead Global Payer Team(s) that support the payer planning process, including the situation analysis and the creation of global payer plans. This will include the development of new plans as well as the update of prior plans to reflect changes in product data and/or the global payer environment.\n\nEach member of the team must work collaboratively across functions to ensure a comprehensive view of his/her assigned products and create and maintain strong collaborative working relationships with key stakeholders. These stakeholders include colleagues in marketing, development, health economics, regulatory, operations, and government affairs.The individual must also oversee and conduct relevant payer/pricing research and integrate clinical, market, and payer information to develop and communicate the plan.\n\nIn addition to product-specific responsibilities, each member of the team also participates in one or more cross-portfolio projects each year. These projects either serve to advance the team\u2019s knowledge of and readiness for the global payer environment, support specific market or product assessments, or attempt to influence payer policy development. Examples include: Payer assessments to support potential mergers/acquisitions, payer landscape in emerging markets, exploration of new payer trends (e.g., bundling), or development of a policy white paper to shape external price and reimbursement policies in the global arena.\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications \u2022 Strong understanding of payer environment, both within the US and globally, including coverage and reimbursement, pricing, value drivers, formulary management, health technologies assessment, health policy\n\u2022 Ability to conduct situation analysis of external pricing and reimbursement environment and synthesize relevant information to develop strategic plans\n\u2022 Ability to develop and test value messages and value evidence with payers in order to determine the most compelling way in which to demonstrate and communicate product value to payers\n\u2022 Ability to conduct qualitative and quantitative pricing studies and to formulate price policy recommendations\n\u2022 Ability to formulate health policy strategy and implement these strategies to shape external pricing and reimbursement environment\n\u2022 Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies, in order to understand implications for value to payers\n\u2022 Excellent communication skills, including interpersonal skills to foster collaboration and succeed in a highly matrixed environment; strong oral/written presentation skills\n\u2022 Demonstrated success as a team leader with strong team management skills\n\u2022 Clinical degree (PharmD, MD, RN) and experience strongly preferred\n\u2022 Direct payer experience and/or experience in product commercialization desirable\n\u2022 Strategic planning and health policy experience strongly preferred\n\u2022 Pharmaceutical pricing experience strongly preferred\n\u2022 Previous international (ex-US) assignment desirable", "date_new": "2012-03-18 20:10:24", "url": "http://www.amgen.jobs/xml/27229088/job", "country": "United States", "company": "Amgen", "title": "Reimbursement Director, Global Value and Access", "reqid": "14408BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27229088}, {"country_short": "GRC", "city": "Athens", "description": "Auto req 14312BR\nJob Posting Title Product Manager Oncology\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Greece\nLocation (City) Athens\nAmgen Job Description Reporting to the Sr Mgr Business Unit Oncology, the person will have the purpose of:\n\u2022 Maximises the brand potential at national level\n\u2022 Executes Country Operating Plan\n\u2022 Delivers branding campaign in line with international guidance\n\nResponsibilities:\n\u2022 Drives motivation of sales force towards brand aspiration (cycle and launch meetings)\n\u2022 Develops and implements Country Brand Plan in full congruence with International Brand Plan\n\u2022 Designs and executes promotional activities (detail aids, message scripts, advertising, congresses, etc.) in line with international branding and key messages\n\u2022 Develops LRP with Business Planner\n\u2022 Proposes national sales target and achieves agreement with Business Unit Leader and Sales/District Managers\n\u2022 Partners with international PM\n\u2022 Translates/implements international brand campaign locally\n\u2022 Analyses market research and develops POA\n\u2022 Coordinates competitive intelligence and drives competitive action plans\n\u2022 Partners with the Medical Affairs Manager to optimize the brand performance (goals of clinical trials, KOL development, etc.)\n\u2022 Agrees with other PM in Franchise Team on joint projects\n\u2022 Recruits and manages external vendors\n\u2022 Identifies business opportunities and develops business cases\nBasic Qualifications \u2022 Academic education or experience from similar positions and therapeutic area\n\u2022 Minimum 3 years of experience in industry\n\u2022 Minimum 2 years of experience as a Product Manager\n\u2022 Fluency in English, both oral and written communications\n\u2022 Financial and budgeting skills and experience\n\u2022 Documented track record of product launch\n\u2022 Computer skills (MS Office programs)\n\u2022 Tenure at last two jobs for at least 2 years each\nPreferred Qualifications Preferred Requirements:\n\u2022 Minimum 2 years in a large pharmaceutical company\n\u2022 1 to 3 years as a Pharmaceutical Sales Representative\n\u2022 Minimum 2 years of experience in a US pharmaceutical company\n\u2022 Documented experience in Franchise area (e.g., Oncology, Nephrology, etc.)\n\u2022 Documented success in gaining or maintaining market leadership position", "date_new": "2012-03-16 20:16:58", "url": "http://www.amgen.jobs/xml/27211281/job", "country": "Greece", "company": "Amgen", "title": "Product Manager Oncology", "reqid": "14312BR", "state": null, "state_short": null, "location": "Athens, GRC", "uid": 27211281}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14115BR\nJob Posting Title Principal Scientist - Chemicals, Product and Process Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position is for a subject matter expert within the Product and Process Engineering Organization responsible for providing scientific and technical leadership and strategic direction to the evaluation of designated raw materials, in this case chemicals and excipients used in biopharmaceutical manufacture, and their potential impact on product quality and process performance.\n\nExtensive knowledge of the manufacturing processes of raw materials, their usage, regulatory/compendial requirements, practices, physical/chemical properties and compatibility with proteins, and risks associated with the raw materials for pharmaceutical and biological products is desirable, along with the ability to assess the impact of changes in materials or manufacturing processes. This individual will be responsible for assessing supplier capabilities, technical competencies and understanding of the needs of biopharmaceutical manufacturers along with other team members. The successful candidate will support or lead cross-functional teams of experienced scientists and engineers through project challenges and mentor them in the selection of the most appropriate materials and technologies. The candidate will actively chart the course and translate business strategies into challenging, actionable objectives and plans, and will apply meaningful metrics for projects, personnel and other resources.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 PhD in chemistry, or MS in chemistry with multiple years in the manufacture of pharmaceutical grade materials\n\u2022 Ten years relevant work experience in pharmaceutical/biopharmaceutical applications\n\u2022 Knowledge of Regulatory Filings and the drug development process\n\u2022  Familiarity with aspects of the use of materials in biopharmaceutical applications, from sourcing, developing collaborative relationships between supplier and user, dealing with change notifications and non-conformance investigations.\n\u2022 Knowledge of state of the art technologies and emerging scientific and regulatory directions for testing and securing quality and minimizing variability.\n\u2022 Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.\n\u2022 Should be recognized in the scientific community and supplier base through a sustained record of publications and patents.\n\u2022 Should have strong communication skills, both written and oral.\n\u2022 Ability to network and build solid working relationships within and across departments, with diverse and remote staff and with external collaborators from key suppliers.\n\u2022 Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans.\n\u2022 Team leadership, management, and facilitation skills are required.\n\u2022 Ability to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas.", "date_new": "2012-03-16 02:42:34", "url": "http://www.amgen.jobs/xml/27183556/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - Chemicals,  Product and Process Engineering", "reqid": "14115BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27183556}, {"country_short": "USA", "city": null, "description": "Auto req 14334BR\nJob Posting Title Sr Regional Medical Liaison\nCareer Category Medical Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Field Based\nLocation (City) Field Based\nAmgen Job Description This position is a field-based position for the Inflammation Therapeutic Area Regional Medical Liaison (RML) team within the Scientific Affairs organization. The territory will cover Washington, D.C., Baltimore, and the greater Washington area in Maryland (including Bethesda, Gaithersburg, Frederick, Cumberland, Annapolis, and portions of Eastern Shore).\n\nThe Senior Regional Medical Liaison (Sr RML) will interact with healthcare decision makers, including investigators, to communicate and advance the scientific platform as aligned with Amgen's corporate goals and objectives. The Sr RML is an integral position in assuring accuracy in communication of our science and products across the medical community. The successful Sr RML will communicate complex cutting-edge scientific information and research concepts to healthcare decision makers including, but not limited to, those at Centers of Education and Research. In addition, the Sr RML will provide feedback based on field interactions and scientific support consistent with Amgen goals.\n\nThe Sr RML will:\n\u2022 Interact with healthcare thought leaders to communicate and advance the scientific platform, as aligned with Amgen\u2019s corporate goals and objectives\n\u2022 Communicate complex cutting edge, scientific information and research concepts to healthcare decision makers, including but not limited to, those at Academic Medical Centers\n\u2022 Support Amgen sponsored research\n\u2022 Provide feedback based on field interactions with healthcare opinion leaders\n\u2022 Foster scientific relationships between Amgen and Fellows-in-training\n\u2022 Lead and/or participate on committees or project teams that support RML strategies and tactics as delegated by RML leadership\n\u2022 Mentor RML\u2019s as designated by RML leadership\n\u2022 Seek out opportunities to support the RML value proposition and achieve results and set an example for others to follow by consistently demonstrating Amgen Values and Leadership Attributes.\n\u2022 Demonstrate tact and organizational savvy when communicating and interacting with others.\n\u2022 Remain agile regarding assignment changes based on research priorities and needs at the direction of RML leadership\n\nThe Sr RML will model openness and innovation through words, actions, and decisions. Amgen RMLs share learning including entrepreneurial and innovative ideas with others and hold self accountable for performance, as well as encouraging others to achieve and be accountable for performance.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nPreferred Qualifications Pharm.D., Ph.D., or M.D. (Other Doctoral Degrees considered)\n- 7 or more years of experience in a medically related field, including 1 or more years focused on clinical practice, clinical research, or medical research. Experience in a medically related field can include post doctoral training (i.e., residencies and/or fellowships).\n- 3 + years in a medical science liaison role in a biotech or pharmaceutical company\n-experience in Scientific Affairs or Medical Affairs at a biotech or pharmaceutical company\n-Inflammation therapeutic expertise area knowledge", "date_new": "2012-03-16 02:42:29", "url": "http://www.amgen.jobs/xml/27183553/job", "country": "United States", "company": "Amgen", "title": "Sr Regional Medical Liaison", "reqid": "14334BR", "state": null, "state_short": null, "location": "Virtual, USA", "uid": 27183553}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14239BR\nJob Posting Title Research Operations Manager - Amgen Tissue Bank\nCareer Category Preclinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.\n\nAs an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.\n\nAmgen Tissue Bank (ATB) is seeking a highly motivated individual to join our multidisciplinary team in Thousand Oaks, CA.\n\nAmgen Tissue Bank is a biobank that procures and maintains a collection of tissues for use by Amgen researchers.\n\nThe individual in this role will provide expert, project-specific guidance to scientific staff, design and manage complex sample procurement strategies involving Amgen staff, external vendors and service providers, maintain and manage specimens, data and financial records, prepare detailed reports, use analytical skills to assess accuracy of detailed information and ensure compliance with regulations.\nThe successful individual will work independently under minimal direction, and collaborate with various teams within Amgen, Amgen vendors, and Service Providers.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Degree in allied health, biological, or life sciences\n\u2022 Familiarity with medical and scientific terminology\n\u2022 Possess initiative, independence, flexibility, willingness to learn, ability to embrace challenges, and a strong commitment to quality\n\u2022 Strong interpersonal, verbal, and written skills essential\n\u2022 Detail oriented, proactive, ability to work independently and in teams\n\u2022 Proficiency with Microsoft Excel, Word, Sharepoint, and document management applications (Documentum, EDM)\n\u2022 Familiarity with databases and data analysis software (LIMS, Access, SigmaPlot, SpotFire, etc.)\n\u2022 Strong organizational, time, and project management skills, ability to prioritize, plan and facilitate meetings, identify and track progress on action items\n\u2022 Previous knowledge or experience in a histology/pathology/medical technology laboratory environment desirable\n\u2022 Familiarity with GxP regulations a plus", "date_new": "2012-03-16 02:41:54", "url": "http://www.amgen.jobs/xml/27183540/job", "country": "United States", "company": "Amgen", "title": "Research Operations Manager - Amgen Tissue Bank", "reqid": "14239BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27183540}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14338BR\nJob Posting Title Director of Enterprise IS Technology Services Design and Engineering\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Director of Enterprise IS Technology Services Design & Engineering is responsible for the development, delivery, and life cycle of Amgen IS Infrastructure technologies. Leading a team of multi-disciplinary experts and providing Engineering direction across the organization, this position will deliver timely designs and implementations from the existing technology portfolio, create new solutions, and maintain the technology portfolio life cycle.\n\nJob Responsibilities\n\u2022 Be accountable for developing, delivering and maintaining Enterprise Information Systems Technology Services (EISTS) portfolio consisting of an integrated set of designs, detailed specifications, roadmaps and program delivery for solutions delivered by EISTS, which includes Application Hosting, Networks, End User Technology and Integrated Services.\n\n\u2022 Ensure the relevance and completeness of designs and delivered solutions to EISTS service owners.\n\n\u2022 Accountable to ensure IS projects leverage and maximize value Engineered solutions from the portfolio technologies through strong collaboration within EISTS and across IS.\n\n\u2022 Lead the introduction of new EISTS Technologies into the portfolio to enable business value driven innovation while maximizing organizational effectiveness and efficiency.\n\n\u2022 Maintain the technology portfolio life cycle for EISTS, including driving the retirement of obsolete or declining technologies and delivery of successor technologies to enable efficient service provision and minimize risks.\n\n\u2022 Enhance cross IS Technology governance, establish and lead new engagements at both the strategic and the project levels to define and implement a shared technical vision and lifecycle roadmap.\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nAND\n4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Master\u2019s degree\n\u2022 Bachelor\u2019s Degree in Information Systems, Computer Science, or Electronics.\n\u2022 15 + years experience working within information systems\n\u2022 8+ years experience supervising cross-technology engineering staff on large and small IS infrastructure technology delivery\n\u2022 Meaningful technical design engineering leadership experience with global companies using Information Technology and Services in regulated environments. Additional experience with technology supply companies a plus.\n\u2022 5+ years biotechnology or pharmaceutical experience are a plus.\n\u2022 Strong leadership and communication skills to convince all stakeholders on programs and portfolio investments.\n\u2022 The ability to function in multiple roles based on project demands.\n\u2022 Strategic leadership experience and ability to facilitate alignment and investment across multiple geographies, functions, and disciplines.\n\u2022 Excellent oral, written and interpersonal communication skills\n\nThis position requires a senior and credible IS Infrastructure technology design and delivery leader, with broad experience and demonstrated success leading an Infrastructure engineering design and delivery team. It requires also a passion for Information Technology and engineering, in depth understanding of Infrastructure technologies, of technology integration, and of industry practices.\n\nLearning agility, technical excellence, technical management, discipline and the capability to engage and collaborate across the IS Function in a relationship based organization to drive change and continuous improvement at all levels are essential attributes.\n\nThis individual will leverage his/her long experience in designing and delivering global information infrastructure systems in a regulated environment for the Enterprise and a diverse range of specialized business needs and partner with business IS and other Enterprise shared services.", "date_new": "2012-03-14 18:24:07", "url": "http://www.amgen.jobs/xml/27135934/job", "country": "United States", "company": "Amgen", "title": "Director of Enterprise IS Technology Services Design and Engineering", "reqid": "14338BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27135934}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14290BR\nJob Posting Title CDM Systems Manager\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description THIS ROLE CAN BE BASED AT AMGEN\u2019S THOUSAND OAKS, CA OR SOUTH SAN FRANCISCO SITE\n\nServe as primary point-of-contact to coordinate and lead comprehensive and holistic Clinical Data Management system services to Data Management Therapeutic teams.\n\nThe Manager of Client System Services \u2013 CDM Systems Interface (CSI) role will ensure the proper, timely, and successful setup and implementation of clinical data management services during study startup, study maintenance, and study closeout for individual study teams. The CSI will ensure the most effective use, implementation, and observance of systems and data standardization, and status of CDM System services including but not limited to EDC, clinical trial database programming deliverables, including database, edit check, custom report programming, CDM Systems lab administration, CDM SAS programming deliverables, including data transfer plans, electronic data load, lab range entry, lab data review, IVRS, IWT, and SAS macros and other clinical data management activities according to study startup timelines in a regulatory compliant manner.\n\nThis position is expected to partner effectively with other CDM System team members to seamlessly ensure high quality deliverables serving as the primary point of contact as a program management function to the systems and technology setup and operations supporting study management activities. The CSI is expected to ensure and support continuous global operations of Amgen\u2019s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization.\n\nOther responsibilities include:\n\u2022 Mentor and support junior staff\n\u2022 Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines.\n\u2022 Procurement and program management of resources, timeline, and services from both internal and external service providers\n\u2022 Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology\n\u2022 Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers\n\u2022 Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives\n\u2022 Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished\n\u2022 Develop strong relationship with external providers (such as FSP and Vendor Provider) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT\n\u2022 Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery\n\u2022 Previous experience working in a global environment\n\u2022 Previous Data Manager in clinical development setting or study team related experience\n\u2022 Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable\n\u2022 Work experience implementing other clinical technologies including but not limited to IVRS, IWT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary\n\u2022 Knowledge of ITIL v3 and basic Industry IS best practices\n\u2022 Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills\n\u2022 Excellent time management and organization skills required\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\u2022 Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable", "date_new": "2012-03-14 03:14:47", "url": "http://www.amgen.jobs/xml/27126977/job", "country": "United States", "company": "Amgen", "title": "CDM Systems Manager", "reqid": "14290BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27126977}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 10371BR\nJob Posting Title Principal Engineer - Primary Container Manufacturing\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Primary Container Manufacturing and Device Mechanical Engineer\nThe successful candidate for this position is required to provide hands-on technical leadership to primary container mechanical design.\n\nJob responsibilities will be primarily focused on;\n1. Leading the characterization of mechanical interfaces / interactions of primary containers with equipment and devices,\n2. Development of test methods for mechanical characteristics,\n3. Produce models and drawings using Solid Works,\n4. Perform basic engineering analysis such as tolerance stack up and FMEAs,\n5. Develop and leverage a basic working knowledge of relevant manufacturing processes to apply Design for Manufacturability\n6. Develop and execute test protocols and publish associated reports\n7. Support the maintenance and creation of Design History Files in accordance with established Company's Product Development Process\n\nThis role will be required to collaborate extensively with external suppliers and Drug Delivery/Device teams\n\nThis position may have supervisory opportunities and responsibilities for technical personnel.\nThis position will report to the leader of the Vendor Process Design and Control group and will be located in Thousand Oaks California.  Some domestic and international travel will be required.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph. D. in Materials Science or Mechanical Engineering with 5 or more years of experience in the Pharmaceutical/Biotechnology industry, Medical Device industry.\n\u2022 Experience to include materials processing, mechanical design, physical characterization of glass and plastic systems, statistical process control (SPC), and design of experiments (DOE).\n\u2022 Strong problem solving, trouble shooting, and communication skills are preferred.\n\u2022 Ability to coach junior engineers, participate in global cross-functional teams, and work effectively in a highly matrix environment.\n\u2022 Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic filling processing.\n\u2022 Experience in managing multiple projects simultaneously, strategically prioritizing activities, and leading cross functional teams.", "date_new": "2012-03-14 03:14:34", "url": "http://www.amgen.jobs/xml/27126960/job", "country": "United States", "company": "Amgen", "title": "Principal Engineer - Primary Container Manufacturing", "reqid": "10371BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27126960}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14269BR\nJob Posting Title Director, Design Assurance - Drug Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful Director of Design Assurance (DA) will lead and build a dynamic team that supports all new product development across the organization. In this high profile assignment you will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing technology. This team are responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. A key driver of success in this role is to translate design requirements into processes that ensure quality attributes in the final design are maintained and are practical for manufacturing.\nThe candidate will work closely with R&D to facilitate the development of innovative technology in a timely manner. Programs are focused on early development through transition to manufacturing with some sustaining work and will include risk management, reliability and failure analysis, and quality planning. Other responsibilities include independently determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements.\nKey Responsibilities:\n\u2022 Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria.\n\u2022 Ensure team works closely with product development engineering and the client team to establish the system design specifications and product requirements.\n\u2022 Ensure team works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles.\n\u2022 Plans, coordinates and executes design verification testing to directly support the master verification plan, including any additional activities such as HALT/HASS and IEC 60601-1-x testing and other standardized test methods.\n\u2022 Participates with the engineering team to establish and review the design FMEA, FMECA and other risk related activities (ISO14971).\n\u2022 Facilitate the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device reliability quality improvements, customer satisfaction, supplier and component initiatives, and safety.\n\u2022 Product reliability design improvements by ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction. Validated product changes with completed documentation that meets or exceeds established guidelines, plus well-documented research/analyses that support decisions and conclusions.\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nAND\n\u2022 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Advanced degree in an Engineering discipline, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments.\n\u2022 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources and have lead the commercial launch of a medical device.\n\u2022 Certified Quality Assurance professional with 3+ years of direct experience in Quality.\n\u2022 CQA, CQM, Six Sigma Black Belt preferred.\n\u2022 ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485).\n\u2022 Lean and or Six Sigma Certification.\n\u2022 Previous experience in DA engineering and commercialization process with drug delivery devices and combination drug/device products is desired\n\u2022 DA experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal).\n\u2022 Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation.\n\u2022 Microcontroller based firmware experience, Real time OS and SW design test, verification and validation experience (unit, static, dynamic and Cyclomatic complexity analysis).\n\u2022 Ability to write software test cases, protocols, and reports.\n\u2022 Experience with circuit design, analysis, troubleshooting, and testing.\n\u2022 Familiar with PCB/PCA assembly and fabrication.\n\u2022 Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools\n\u2022 Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected.\n\u2022 Experience with complex, cross-functional development projects.\n\u2022 Experience working with and leading cross-cultural teams.\n\u2022 Proven ability to apply situational leadership concepts across various intra and inter-departmental matters.\n\u2022 Demonstrated time management, decision making, presentation and organization skills.\n\u2022 Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.", "date_new": "2012-03-14 03:14:28", "url": "http://www.amgen.jobs/xml/27126959/job", "country": "United States", "company": "Amgen", "title": "Director, Design Assurance - Drug Delivery", "reqid": "14269BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27126959}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 14024BR\nJob Posting Title Post Doctoral Fellow - Functional Biocharacterization\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Washington\nLocation (City) Seattle\nAmgen Job Description We are seeking a highly motivated, creative postdoctoral fellow to investigate and develop approaches for assessing Fc-mediated effector functions of therapeutic monoclonal antibodies. The project will require extensive cellular and molecular biology including the development and use of in vitro cell-based assay systems and in vivo animal models.\nBasic Qualifications This position requires a Ph.D. in immunology, cell biology, molecular biology, or related field. Ph.D. must be awarded before the start of the post doctoral position.\nPreferred Qualifications The candidate must have excellent cell culture, cell biology, molecular biology, and analytical skills as well as a good understanding of antibody Fc effector functions. The candidate must be highly self-motivated, have excellent communication skills (oral and written), and the ability to work independently and in a multidisciplinary team environment.", "date_new": "2012-03-14 03:14:26", "url": "http://www.amgen.jobs/xml/27126957/job", "country": "United States", "company": "Amgen", "title": "Post Doctoral Fellow - Functional Biocharacterization", "reqid": "14024BR", "state": "Washington", "state_short": "WA", "location": "Seattle, WA", "uid": 27126957}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14174BR\nJob Posting Title Human Resources Sr Mgr, Project Management, Mergers and Acquisitions\nCareer Category Human Resources\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This HR Senior Manager position is within Amgen's HR Program Management Office, responsible for leading high priority, high impact projects and initiatives that span across Amgen HR and in many cases across Amgen corporate-wide.\n\nProjects typically affect multiple functions, locations and countries requiring excellent collaboration skills, clear decision-making capabilities and business maturity.\n\nThe position provides project management leadership to high priority initiatives which may include but not be limited to:\n\n\u2022 Domestic and International Mergers & Acquisitions. Activities include: management of all phases of M&A from due diligence/deal valuation through post-merger integration. Tasks typically include identification of resources to support HR activities, leadership and coordination of HR deal teams and integration plans; creation and management of HR deal budgets; coordination of communications with non-HR functions; and serving as primary liaison to Corporate Development, Legal and Business leadership. May require international business travel and/or short-term assignment in international locations.\n\n\u2022 Select HR portfolio projects that further Amgen\u2019s HR strategy (e.g., project managing selection and implementation of new Talent Management tool and related processes). Activities typically include: creation and tracking of project plans and timelines, identification and resolution of team-related cross-functional issues, working with leaders to identify and focus teams on critical path activities, and developing and delivering status reports to senior leadership.\n\nSome travel will be required for this role - approximately 10-20%.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 MBA or other advanced degree\n\u2022 Demonstrated comfort with ambiguity and organizational change is critical for success in this position\n\u2022 Strong knowledge of, and experience in, breadth of HR roles, both COE and HRBP\n\u2022 Previous experience with M&A/integration management \u2022 Demonstrated project leadership skills, including ability to manage diverse cross-functional teams\n\u2022 Outstanding written/oral communication and presentation skills at senior executive levels\n\u2022 Ability to understand, balance, and articulate both tactical and strategic planning issues\n\u2022 Strong quantitative, analytical (technical and business), and problem solving skills\n\u2022 Persistent, tactful, and persuasive team and project leadership, including conflict resolution and negotiation skills\n\u2022 Ability to prioritize across multiple projects and handle diverse assignments simultaneously", "date_new": "2012-03-12 00:23:55", "url": "http://www.amgen.jobs/xml/27064044/job", "country": "United States", "company": "Amgen", "title": "Human Resources Sr Mgr, Project Management, Mergers and Acquisitions", "reqid": "14174BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27064044}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14278BR\nJob Posting Title Principal IS Business System Analyst (Enterprise Application Services Project Portfolio Senior Manager)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Job Summary\nThe Enterprise Applications Services (EAS) Project Portfolio Senior Manager is responsible for providing oversight and coordination for all projects across EAS. The Senior Manager works with the EAS SLT to ensure that the EAS project portfolio aligns with business and IS strategies and priorities to deliver maximum value. The position combines both strategic and advisory elements, as well as hands-on management and analysis activities.\n\nJob Responsibilities:\n\u2022 Collaborates with the EAS leadership, CFIS, project managers and system owners to develop and manage project and program budgeting, cost estimation approaches and resource allocation for EAS.\n\u2022 Collaborates with EAS leadership, EAS project managers, Enterprise-wide Portfolio Management group and other portfolio governing bodies by participating in and supporting the latest estimate annual budgeting process and other portfolio related activities.\n\u2022 Works with EAS leadership and key stakeholders to prioritize EAS projects based on changing functional needs, resource capacity, and risk exposure.\n\u2022 Works with EAS leadership and project managers to develop resourcing strategies to ensure optimum support for projects and for the day to day operational activities.\n\u2022 Communicates status of overall EAS portfolio and facilitates communication of projects to EAS leadership and other key stakeholders.\n\u2022 Delivers portfolio level planning and reporting, while ensuring projects are aligned with the business and IS strategies.\n\u2022 Maintains overall project budgetary oversight responsibility for EAS.\n\u2022 Understands and communicates changes to budget approval and monitoring processes. As required, provides training to EAS staff on budget processes.\n\u2022 Communicates and monitors due dates for portfolio related deliverables.\n\u2022 Develops improvement techniques within portfolio management to achieve process efficiencies, innovation, and operational excellence.\n\u2022 Manages the EAS portfolio using Amgen\u2019s portfolio management tool. Supports PMs with the creation and editing of projects in the tool. Completes project change and close out notifications.\n\u2022 Facilitates the project initiation and approval and supports project managers through the capital funding process.\n\u2022 Supports individual projects by providing advice and guidance regarding project governance, management and benefits realization.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Master\u2019s degree\n\u2022 Bachelor\u2019s Degree in Engineering, Information Systems, Computer Science, Business, Finance or the Life Sciences.\n\u2022 Strong financial background\n\u2022 5 + years experience working within information systems and/or project management\n\u2022 Strong oral, written and interpersonal communication skills\n\u2022 Knowledge of Amgen Business and IS practices as well as previous experience with global projects\n\u2022 Sound experience managing of IT, business analysis or business change\n\u2022 IT Financial management expertise including competency in business analysis and business case development.\n\u2022 Proven influencer and communicator with stakeholders at all levels.\n\u2022 Delivering results: ability to plan and organize self and work in order to achieve objectives and targets. Is determined to deliver outcomes and is able to overcome obstacles in order to move forward. Accountable for the delivery of outcomes, strives to meet and exceed the expectations of customers.\n\u2022 Influencing and negotiating: has the confidence and gravitas to influence and challenge at executive level.\n\u2022 Working with others: ability to work effectively with colleagues, managers, suppliers and stakeholders. Understands the importance of developing effective partnership relationships with key suppliers.", "date_new": "2012-03-10 18:08:23", "url": "http://www.amgen.jobs/xml/27057976/job", "country": "United States", "company": "Amgen", "title": "Principal IS Business System Analyst (Enterprise Application Services Project Portfolio Senior Manager)", "reqid": "14278BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27057976}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 14287BR\nJob Posting Title Principal Scientist\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nAmgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.\n\nAs an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.\n\nThe successful employee will provide scientific and managerial leadership to a group of scientists/associates as well as manage collaborations for the Genome Analysis Unit (GAU), a strategic innovation group within Discovery Research at Amgen. The group is based in 3 separate sites and consists of 31 staff members. The group operates semi-autonomously but also collaboratively across all Research to deliver large molecule therapeutics for oncology, metabolic disorders, and inflammation, as well as to develop innovative platform technologies that enable drug discovery.\n\nThe successful employee is expected to be knowledgeable in cancer biology and/or other areas of disease biology that are/is of interest to Amgen Research. The employee is expected to partner with the leads of the computational biology group within the GAU to interpret complex data analysis, to decipher and develop hyphotheses for new therapeutic targets, and design in vitro and in vivo studies to characterize impact of target modulation, and manage a wide range of interdepartmental project collaborations.\n\nThe employee must possess industry experience, experience in staff management, ability to harmonize between different teams within Discovery Research, as well as with external groups including Molecular Sciences, Clinical Immunology, and Research Imaging Sciences for effective collaboration in a matrixed environment.\n\nThe employee will be expected to contribute to strategic, tactical, and operational discussions for the GAU. Knowledge of Amgen Research environment is a plus.\nBasic Qualifications \u2022 Doctorate degree & 5 years of scientific experience\nOR\n\u2022 Master\u2019s degree & 12 years of scientific  experience\nOR\n\u2022 Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications \u2022 Doctorate degree in life sciences and 5 or more years of directly related experience\n\n\u2022 5+ years of experience in industry with management responsibilities, demonstrated ability to effectively interface with leaders across an organization and manage collaborations, project team leadership\n\n\u2022 Relevant knowledge of the development of protein therapeutics, molecular and cell biology, genetics, cancer biology, next-gen-sequencing, strong written and verbal communication", "date_new": "2012-03-09 18:35:23", "url": "http://www.amgen.jobs/xml/27037842/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist", "reqid": "14287BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 27037842}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14250BR\nJob Posting Title Category Sr Mgr\nCareer Category Procurement\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Category Senior Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Senior Manager will be responsible for business case development, strategic sourcing and ongoing supplier management for assigned scientific and/or laboratory services categories that support Amgen\u2019s Discovery Research and Translational Sciences functions.\n\nWorking within a matrix environment, the Category Senior Manager is responsible for applying in-depth disciplinary knowledge, business acumen and subject matter expertise to deliver strategic sourcing objectives. The Category Sr Manager employs category management, project management and change management techniques to effectively deliver strategic sourcing initiatives. The Category Sr Mgr leads the category management process, which includes conducting business opportunity analysis, make/buy analysis, data analysis, requirements gathering, development and execution of RFx, sourcing strategy development and implementation, contract development, negotiation and management, supplier on-boarding, and implementation and support ongoing supplier governance. Leading project and program teams accountable for successful source and supplier development and management is fundamental to the role.\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\n-Master\u2019s degree & 6 years of directly related experience\nOR\n-Bachelor\u2019s degree & 8 years of directly related experience\nOR\n-Associate\u2019s degree & 10 years of directly related experience\nOR\n-High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MBA preferred\n\n5+ years of Strategic Sourcing experience\n3+ years Biotech/Pharmaceutical experience\n7+ years experience in a complex business environment\nCertified Purchasing Manager (CPM), Project Management Professional (PMP), and/or Green/Black Belt Six Sigma certification\nCategory sourcing experience in Research and Development categories such as scientific services, or laboratory support services\nGeneral understanding of Biotech/Pharmaceutical practices and standards\nIn-depth knowledge of the principles, methods and practices as they relate to strategic sourcing, project management and/or change management\nExperience contributing to the development of a category strategy with business partners\nAbility to translate company goals into category priorities, strategy and direction\nAbility to work in a complex business environment\nApplies data gathering and analytical skills to drive fact based decision making\nDevelop innovative and creative outputs based on insightful interpretation and analysis\nAbility to define opportunities and risks and facilitate selection of appropriate alternatives\nAbility to proactively identify roadblocks and effectively identify and execute solutions\nPlan, track and report progress of sourcing related initiatives\nWork independently to establish initiative timeline, managing deliverables and ability to appropriately identify and escalate issues when needed\nAbility to build productive internal relationships and strategic supplier partnerships\nDemonstrated negotiation, conflict resolution and stakeholder management capabilities\nStrong oral and written communication skills and excellent organization and planning skills", "date_new": "2012-03-08 19:15:42", "url": "http://www.amgen.jobs/xml/27012353/job", "country": "United States", "company": "Amgen", "title": "Category Sr Mgr", "reqid": "14250BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27012353}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14249BR\nJob Posting Title Sr Project Manager - Manufacturing of the Future (MoF) Engineering\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The MoF Engineering Project Manager is responsible for coordinating elements of MoF engineering design and leading multiple MoF engineering work streams. The engineer shall provide direction to the operations team on the engineering elements needed to ensure all projects and facilities under the MoF program become qualified and operational within specified timeframe and budgets.\n\nThis role will require up to 50% travel and is located in Thousand Oaks, CA.\n\nKey responsibilities include, but are not limited to, the following:\n\nTechnical / Design Leadership: Provide leadership to align technical issues across all MoF capital projects and interface with the equipment team leads. Ensure projects align with Amgen\u2019s technical business processes.\n\nPlanning: Interface with equipment and project teams to ensure there is alignment of key program milestones and articulate the impact of changes in projects or program on the individual schedules. Develop specific action plans with deliverables and resources needed to deliver elements such as program maintenance of the new facility and equipment, all Maximo elements, calibration, etc.\n\nConstruction: Oversight of technical issues that arise during construction, ability to understand programmatic aspects of decisions made and skills to understand when necessary to escalate issues to the leadership.\n\nCommissioning: Ensure proper commissioning programs are developed and used, and qualification processes are implemented.\n\nMaintenance: Develop maintenance program with operations team, interfacing with project teams, leadership team, Engineering Technical Authority, and receiving site. Monitoring progress, resolving technical conflicts.\nBasic Qualifications Doctorate degree and 2 years of directly related experience\nOR\nMaster\u2019s degree and 6 years of directly related experience\nOR\nBachelor\u2019s degree and 8 years of directly related experience\nOR\nAssociate\u2019s degree and 10 years of directly related experience\nOR\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications \u2022 Background in drug substance manufacturing facilities, well rounded experience in design, project engineering, process engineering, qualification, and maintenance\n\u2022 Masters Degree in Engineering, Chemical, BioChemical, Mechanical\n\u2022 Professional registration, such as a Professional Engineer license\n\u2022 10 years engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, and CIP/SIP including 5 years experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, deciding cost/benefit analysis)\n\u2022 5 years experience in engineering in biotech/pharmaceutical industry in manufacturing support (quality, process development, manufacturing, clinical manufacturing)\n\u2022 Strong communication, relationship building, leadership and mentoring skills\n\u2022 Proven ability to manage and deliver results in a highly fluid, interactive matrix environment", "date_new": "2012-03-08 19:15:41", "url": "http://www.amgen.jobs/xml/27012351/job", "country": "United States", "company": "Amgen", "title": "Sr Project Manager - Manufacturing of the Future (MoF) Engineering", "reqid": "14249BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27012351}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14225BR\nJob Posting Title Sr Project Manager - Manufacturing of the Future (MoF) Process Development\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Senior Project Manager, Manufacturing of the Future (MoF) Process Development is responsible for establishing and leading cross functional strategic initiatives in support of the MoF operating platform. This role will focus on developing MoF technology transfer methodologies, MoF operational philosophies, and representing the MoF leadership team on interactions with impacted pipeline process teams.\n\nThis role will require up to 50% travel and is located in Thousand Oaks, CA.\n\nKey responsibilities include, but are not limited to, the following:\n\u2022 Partner with process teams to understand / manage risks to program timelines and assess impact to proposed MoF platform deviations\n\u2022 Develop structure and methodologies for transferring new operational philosophies and technologies into the MoF network\n\u2022 Lead the implementation of process analytical technologies (PAT) from analytical sciences into MoF production facilities\n\u2022 Represent the MoF team in the establishment and implementation of MoF platform technologies and processes\n\u2022 Develop Process Development staffing plan for future state MoF operations\n\u2022 Management of multi-disciplinary projects with the development of clearly articulated scope and quantifiable business benefits\n\u2022 Develop specific action plans with deliverables and resources needed to implement new technologies and address gaps between proposed MoF philosophies and existing operating standards or established operational norms\nBasic Qualifications \u2022 Doctorate degree and 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree and 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree and 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree and 10 years of directly related experience\nOR\n\u2022 High school diploma / GED and 12 years of directly related experience\nPreferred Qualifications \u2022 Background in drug substance manufacturing facilities, well rounded experience in design, project engineering, process engineering, qualification, and maintenance\n\u2022 5 years experience associated to inter site product transfers, new product introduction, or technology development\n\u2022 Strong communication, relationship building, leadership and mentoring skills\n\u2022 Proven ability to manage and deliver results in a highly fluid, interactive matrix environment\n\u2022 Candidate should have strong leadership, communication, and interpersonal skills with the ability to approach issues from a strategic perspective and stay focused on the big picture. This includes the ability to develop and translate strategy into actionable objectives to effectively drive the project team, advocate client positions throughout the life cycle of the project, and make value-based decisions.\n\u2022 Applicants should be proficient in project management tools and have experience communicating and presenting ideas to all levels of staff and management", "date_new": "2012-03-08 19:15:02", "url": "http://www.amgen.jobs/xml/27012312/job", "country": "United States", "company": "Amgen", "title": "Sr Project Manager - Manufacturing of the Future (MoF) Process Development", "reqid": "14225BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27012312}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14193BR\nJob Posting Title Category Sr Mgr\nCareer Category Procurement\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Category Senior Manager resides in Global Strategic Sourcing (GSS). Reporting to the GSS Director, the Category Senior Manager will be responsible for business case development, strategic sourcing and ongoing supplier management for assigned scientific and/or laboratory services categories that support Amgen\u2019s Discovery Research and Translational Sciences functions.\n\nWorking within a matrix environment, the Category Senior Manager is responsible for applying in-depth disciplinary knowledge, business acumen and subject matter expertise to deliver strategic sourcing objectives. The Category Sr Manager employs category management, project management and change management techniques to effectively deliver strategic sourcing initiatives. The Category Sr Mgr leads the category management process, which includes conducting business opportunity analysis, make/buy analysis, data analysis, requirements gathering, development and execution of RFx, sourcing strategy development and implementation, contract development, negotiation and management, supplier on-boarding, and implementation and support ongoing supplier governance. Leading project and program teams accountable for successful source and supplier development and management is fundamental to the role.\nBasic Qualifications -Doctorate degree & 2 years of directly related experience\nOR\n-Master\u2019s degree & 6 years of directly related experience\nOR\n-Bachelor\u2019s degree & 8 years of directly related experience\nOR\n-Associate\u2019s degree & 10 years of directly related experience\nOR\n-High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications MBA preferred\n\n5+ years of Strategic Sourcing experience\n3+ years Biotech/Pharmaceutical experience\n7+ years experience in a complex business environment\nCertified Purchasing Manager (CPM), Project Management Professional (PMP), and/or Green/Black Belt Six Sigma certification\nCategory sourcing experience in Research and Development categories such as scientific services, or laboratory support services\nGeneral understanding of Biotech/Pharmaceutical practices and standards\nIn-depth knowledge of the principles, methods and practices as they relate to strategic sourcing, project management and/or change management\nExperience contributing to the development of a category strategy with business partners\nAbility to translate company goals into category priorities, strategy and direction\nAbility to work in a complex business environment\nApplies data gathering and analytical skills to drive fact based decision making\nDevelop innovative and creative outputs based on insightful interpretation and analysis\nAbility to define opportunities and risks and facilitate selection of appropriate alternatives\nAbility to proactively identify roadblocks and effectively identify and execute solutions\nPlan, track and report progress of sourcing related initiatives\nWork independently to establish initiative timeline, managing deliverables and ability to appropriately identify and escalate issues when needed\nAbility to build productive internal relationships and strategic supplier partnerships\nDemonstrated negotiation, conflict resolution and stakeholder management capabilities\nStrong oral and written communication skills and excellent organization and planning skills", "date_new": "2012-03-08 19:14:42", "url": "http://www.amgen.jobs/xml/27012304/job", "country": "United States", "company": "Amgen", "title": "Category Sr Mgr", "reqid": "14193BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27012304}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14039BR\nJob Posting Title 2 x Manager Manufacturing - Syringe Filling & Inspection\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Manager Manufacturing \u2013Syringe Filing & Inspection\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Manager Manufacturing \u2013 Syringe Filling & inspection reports to the Sr Manager Manufacturing \u2013 Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.\n\nResponsibilities include:\n\n\u2022 Responsible for filling and inspection line output during their shift.\n\u2022 Responsible for ensuring that all staff operate within GMP\u2019s and maintaining a safe work environment.\n\u2022 Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.\n\u2022 Responsible for ensuring that all staff operate within GMP\u2019s and maintaining a safe work environment.\n\u2022 Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.\n\u2022 Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.\n\u2022 Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.\n\u2022 Prepared to work on a shift basis, leading a manufacturing team.\n\u2022 Able to travel to other sites within the organization for certain time periods.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering or Science\n\n\nRelevant Experience\n\u2022 Typically 5 \u2013 8 years experience in an aseptic pharmaceutical environment.", "date_new": "2012-03-07 02:05:41", "url": "http://www.amgen.jobs/xml/26971935/job", "country": "Ireland", "company": "Amgen", "title": "2 x Manager Manufacturing - Syringe Filling & Inspection", "reqid": "14039BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971935}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14042BR\nJob Posting Title Sr Engineer - Packaging (Line Owner)\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Engineer \u2013 Packaging\n(Line Owner)\nLevel 5\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the packaging group and be responsible for the execution of all projects in that area. The Sr. Engineer reports to the Sr. Manager Manufacturing \u2013Packaging. The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to packaging equipment and associated automation systems.\nResponsibilities include:\n\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Monitoring of day to day manufacturing operations.\n\u2022 Data trend analysis for all performance aspects of a packaging line.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 Solving or escalating problems as appropriate.\n\u2022 All design reviews associated with equipment purchases.\n\u2022 Troubleshooting performance trends.\n\u2022 Risk assessments and mitigation projects relating to line performance.\n\u2022 Support of new product introductions and supporting introduction of new equipment.\n\u2022 The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.\n\u2022 Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.\n\u2022 Continuous improvement programs and all performance improvement projects.\n\u2022 Review and approval of changes to operating procedures and the change control process relating to the line.\n\u2022 Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\n\u2022 Supporting non conformance investigation.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-03-07 02:05:14", "url": "http://www.amgen.jobs/xml/26971791/job", "country": "Ireland", "company": "Amgen", "title": "Sr Engineer - Packaging (Line Owner)", "reqid": "14042BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971791}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14037BR\nJob Posting Title 4 x Manager Manufacturing - Packaging\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Manager Manufacturing \u2013 Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Manager Manufacturing \u2013 Packing reports to the Sr Manager Manufacturing \u2013 Packaging and will be responsible for the manufacturing teams within the syringe packaging facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.\n\nResponsibilities include:\n\n\u2022 Responsible for filling and inspection packaging line output during their shift.\n\u2022 Responsible for ensuring that all staff operates within GMP\u2019s and maintaining a safe work environment.\n\u2022 Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.\n\u2022 Responsible for ensuring that all staff operates within GMP\u2019s and maintaining a safe work environment.\n\u2022 Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.\n\u2022 Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.\n\u2022 Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.\n\u2022 Prepared to work on a shift basis, leading a manufacturing team.\n\u2022 Able to travel to other sites within the organization for certain time periods.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering or Science\n\n\nRelevant Experience\n\u2022 Typically 5 \u2013 8 years experience in an aseptic pharmaceutical environment.\n\u2022 Previous experience working on packaging lines in a man management role is a distinct advantage.", "date_new": "2012-03-07 02:05:13", "url": "http://www.amgen.jobs/xml/26971785/job", "country": "Ireland", "company": "Amgen", "title": "4 x Manager Manufacturing - Packaging", "reqid": "14037BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971785}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14038BR\nJob Posting Title Senior Engineer - Industrial\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Engineer \u2013 Industrial\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the packaging and syringe groups and be responsible identifying and remediating gaps between emerging business requirements and current capabilities within the filling and packaging operations. The Sr. Engineer reports to the Sr. Manager Manufacturing \u2013 Syringe.\n\nResponsibilities include:\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Performing resource assessments for each area and developing resource standards and labour models\n\u2022 Data trend analysis for all performance aspects of the area.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 Solving or escalating problems as appropriate.\n\u2022 Leading improvement initiatives in areas of waste reduction, right first time approaches and productivity improvement.\n\u2022 Troubleshooting performance trends.\n\u2022 Risk assessments and mitigation projects relating to line performance.\n\u2022 Performing resource gap analysis for machinery and labour and developing strategies to close these gaps.\n\u2022 Continuous improvement programs and all performance improvement projects.\n\u2022 Working with the operational excellence group in implementing OE methods, mentoring project leads and facilitating process improvement teams.\n\u2022 Review and approval of changes to operating procedures and the change control process relating to the line.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Qualification in Lean and 6-sigma methodologies would be an advantage.\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-03-07 02:05:06", "url": "http://www.amgen.jobs/xml/26971749/job", "country": "Ireland", "company": "Amgen", "title": "Senior Engineer - Industrial", "reqid": "14038BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971749}, {"country_short": "RUS", "city": "Moscow", "description": "Auto req 14087BR\nJob Posting Title Accounting Mgr\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) Russia\nLocation (City) Moscow\nAmgen Job Description Responsibilities:\n\u00b7 Responsible for accurate, complete and timely monthly and quarterly US GAAP accounting close:\n\u00b7 Use and review of month-end accounting checklist\n\u00b7 Responsible for preparation of manual Journal Entries and review of manual journal entries posted by other affiliate accounting staff\n\u00b7 Responsible for the preparation of the quarterly account analyses\n\u00b7 Responsible for Statutory quarterly closing: taxes and financial statements\n\u00b7 Ensure compliance to local accounting requirements , corporate internal controls, including reconciliation between Amgen US GAAP books and statutory\n\u00b7 Support local Finance lead with tax compliance, internal and external audit as well as Control Self Assessment exercises and implementation of recommended improvements\n\u00b7 Monitor relationship with outsourcing accounting vendor provider and European SSC\n\u00b7 Take leading part from accounting side in SAP implementation project \u2013 2012 target, then key user\n\u00b7 Ensure timely and accurate preparation of Quarterly Close and Disclosure Checklists (US GAAP)\n\u00b7 Supports implementation of local accounting and other relevant business practices and guidelines (i.e. procedures and policies) in line with International and Corporate guidance\n\u00b7 Support local HR Lead with compliant local payroll process\n\u00b7 Be a close and reliable business partner to local Finance team\n\u00b7 Takes part in any local or International finance and/or accounting project\nBasic Qualifications * Mimimum of 3-5 years of accounting experience in an International company\n* Solid understanding of local (Russian) accounting principles (experience in all areas, financial statements and tax declarations preparation)\n* Strong understanding of US-GAAP/Local GAAP\n* Ability to communicate effectively with others and provide timely, accurate information.\n* Ability to work under limited supervision and tight deadlines\n* Experience in public accounting a plus.\n* SAP system knowledge required\n* Fluent English and Russian (speaking and writing)\nPreferred Qualifications Personal skills:\n- Leadership\n- Focus on results\n- Learning agility\n- Ability to work with multifunctional tasks\n- Proactivity\n- Good time management\n\n\nPreferred Requirements\n\u00b7 Experience in Pharmaceutical Industry\n\u00b7 Experience in implementation of ERP system\n\u00b7 Team management\n\u00b7 Tax inspection/audit experience", "date_new": "2012-03-07 02:04:57", "url": "http://www.amgen.jobs/xml/26971735/job", "country": "Russia", "company": "Amgen", "title": "Accounting Mgr", "reqid": "14087BR", "state": null, "state_short": null, "location": "Moscow, RUS", "uid": 26971735}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14211BR\nJob Posting Title 2 x Sr Associate Tech Engineering - Syringe\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Sr. Associate Tech Engineer - Syringe\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Sr. Associate Tech Engineer operates as part of a process team. This position will initially be part of the team responsible for the commissioning, qualification and start up of Amgen\u2019s new syringe manufacturing facility. On completion of the start up, this position will transition to providing technical support to the manufacturing facility.\n\nKey Responsibilities:\n\nDuring start up the individual will execute all project activities associated with start up of the syringe line, including but not limited to:\n\u2022 Participation in equipment design reviews.\n\u2022 Development and execution of FAT, SAT, IOQ protocols.\n\u2022 Development, revision and review of technical documents such as SOP\u2019s, job plans etc.\n\u2022 A willingness to spend time abroad over the next 2 years.\n\u2022 Ensuring that work is completed in a safe manner under GMP conditions and in accordance with applicable Amgen procedures.\n\nDuring routine manufacturing operations, the individual will provide technical support to the syringe line by:\n\u2022 Ensuring that daily output and compliance requirements are met.\n\u2022 Tracking equipment and process performance to ensure compliance with operating standards.\n\u2022 Implementing corrective actions when deviations from standard are detected.\n\u2022 Ensuring that maintenance personnel have clear definition/guidance when equipment problems are encountered and improvement is required.\n\u2022 Working to investigate, resolve and closeout all issues relating to NC\u2019s, CAPA\u2019s, process deviations.\n\u2022 Owning manufacturing area SOP\u2019s and change control reports.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Degree in Engineering/Science or equivalent\n\u2022 Significant relevant process engineering industry experience\n\nKey competencies:\n\n\u2022 Analytical thinking\n\u2022 Focus on quality\n\u2022 Drive for results\n\u2022 Initiative\n\u2022 Planning and prioritisation\n\u2022 Teamwork and Co-operation\nPreferred Qualifications Preferred Qualifications.\n\u2022 Excellent written and verbal communication skills\n\u2022 Knowledge of applicable Regulatory requirements\n\u2022 Experience with Regulatory inspections desirable\n\u2022 Experience leading cross-functional teams desirable\n\u2022 Experience working with teams and influencing decisions", "date_new": "2012-03-07 02:04:45", "url": "http://www.amgen.jobs/xml/26971668/job", "country": "Ireland", "company": "Amgen", "title": "2 x Sr Associate Tech Engineering - Syringe", "reqid": "14211BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971668}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14219BR\nJob Posting Title 2 x Manager Manufacturing \u2013 Syringe, Component Prep & Formulation\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Manager Manufacturing \u2013 Syringe, Component Prep & Formulation\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThe Manager Manufacturing \u2013 Syringe, Component Prep & Formulation reports to the Sr Manager Manufacturing \u2013 Syringe and will be responsible for the manufacturing teams within the syringe filling facility. The successful candidate will have at least five years of supervisory experience preferably in a pharmaceutical or biotech industry.\n\nResponsibilities include:\n\n\u2022 Responsible for filling and inspection line output during their shift.\n\u2022 Responsible for ensuring that all staff operate within GMP\u2019s and maintaining a safe work environment.\n\u2022 Works in a collaborative manner within all the teams and contributes to investigations, Cross Functional Investigations etc.\n\u2022 Responsible for ensuring that all staff operates within GMP\u2019s and maintaining a safe work environment.\n\u2022 Responsible for ensuring that all material movements and task allocations are carried out effectively to ensure the efficient use of staff and equipment.\n\u2022 Responsible for ensuring that all metrics relating to output, quality, safety and reporting are met.\n\u2022 Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.\n\u2022 Prepared to work on a shift basis, leading a manufacturing team.\n\u2022 Able to travel to other sites within the organization for certain time periods.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering or Science\n\nRelevant Experience\n\u2022 Typically 5 \u2013 8 years experience in an aseptic pharmaceutical environment.\n\u2022 Previous experience of management of Syringe filling and inspection operations is a distinct advantage.", "date_new": "2012-03-07 02:04:18", "url": "http://www.amgen.jobs/xml/26971519/job", "country": "Ireland", "company": "Amgen", "title": "2 x Manager Manufacturing \u2013 Syringe, Component Prep & Formulation", "reqid": "14219BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971519}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 14217BR\nJob Posting Title Engineering Projects Manager - Syringe Fill\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Engineer Project Manager - Syringe Filling\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will be part of the syringe group and be responsible for the execution of all projects in that area. The equipment engineer reports to the Sr. Manager Manufacturing \u2013Syringe. The candidate will apply technical expertise in the management of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes.\n\nResponsibilities include:\n\nThe chosen candidate would typically be involved in activities such as (but not exclusively);\n\n\u2022 Engineering Project lead for Syringe Filing\n\u2022 The provision of manufacturing input to all capital projects relating to the area.\n\u2022 The definition and scoping of all process improvement activities relating to the area.\n\u2022 All design reviews associated with equipment purchases.\n\u2022 The development and execution of FAT, SAT and IOQ protocols in Ireland and abroad.\n\u2022 Representing manufacturing on site based teams involved in implementing new technology, products or business processes to the site.\n\u2022 Continuous improvement programs\n\u2022 Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals.\n\u2022 Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.\nBasic Qualifications Basic Qualifications:\n\u2022 Bachelors degree in Engineering (Mechanical, Electrical or Chemical)\n\u2022 Senior level experience providing solutions and support in the biotechnology or pharmaceutical industries.\n\u2022 Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.\n\u2022 Significant relevant industrial project experience\nPreferred Qualifications Preferred Experience\n\u2022 Typically 8+ years engineering experience in an aseptic pharmaceutical environment\n\u2022 Significant experience large project related activities including GMP qualification experience.", "date_new": "2012-03-07 02:04:02", "url": "http://www.amgen.jobs/xml/26971454/job", "country": "Ireland", "company": "Amgen", "title": "Engineering Projects Manager - Syringe Fill", "reqid": "14217BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26971454}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 10935BR\nJob Posting Title Business Performance Sr Mgr (Commercial)\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role will be focused on North America and International Commercial Operations but may also support other functional areas as well. The Manager of Business Performance will respond to project requests from executives and supervise / execute work with high quality results. In doing so s/he will structure the issues and analyses, manage the work, and prepare and present findings. This role will also support business functions by identifying opportunities and risks and developing the strategies to address them. The Sr. Manager of Business Performance will be responsible for developing approaches to improve productivity and implement comprehensive change strategies to transform an organization and enable it to adapt to business challenges. This role will interact with a wide range of leadership and staff inside and outside of Amgen (consultants).\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Doctorate or Masters in business, finance, science, and/or technology\n\u2022   5+ years experience in biotechnology /pharmaceutical\n\u2022 Experience at a top tier Management Consulting Firm and/or commercial/marketing/sales experience\n\u2022   Strong presence with Senior Executives including ability to communicate effectively on a prepared  and ad-hoc basis\n\u2022   Certification in lean and / or Six Sigma\n\u2022 Experience in budgeting or financial modeling\n\u2022   Strong quantitative and qualitative analytic skills\n\u2022   Excellent conceptual problem solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution\n\u2022   Strong leadership skills with a demonstrated ability to influence different styles\n\u2022   Proven experience as member or leader of a high performing team", "date_new": "2012-03-05 21:20:51", "url": "http://www.amgen.jobs/xml/26933434/job", "country": "United States", "company": "Amgen", "title": "Business Performance Sr Mgr (Commercial)", "reqid": "10935BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26933434}, {"country_short": "DEU", "city": "Munich", "description": "Auto req 14188BR\nJob Posting Title Strategic Sourcing Senior Manager\nCareer Category Procurement\nEmployee Subgroup Salaried FT\nCountry (State/Region) Germany\nLocation (City) Munich\nAmgen Job Description The Function is located at the German affiliate and is responsible to:\n- Secure the availability of services (and goods) in compliance with Amgen\u2019s requirements at minimum total cost and risk (indirect material)\n- Ensure effective management of local strategy development, selection and contracting processes, supply base control and performance and the operational purchasing process\n- Ensure an effective/efficient local Sourcing & Supplier management process in accordance with established Procurement policies and guidelines and to ensure early procurement involvement in sourcing projects\n- Championing and Driving a productivity agenda at the affiliate level, achieving year on year savings through a limited number of large game changing projects\n\nKEY RESPONSIBILITIES:\n\u2022 Local, ad-hoc sourcing:\n- Identify local improvement opportunities with respect to management of Purchase demand, Supply base and Total Cost on a local level\n- Identify and define specific stakeholder requirements\n- Tendering: define evaluation/selection criteria, define and manage Request for Information (RFI) and Request for Proposal (RFP) processes on the basis of the local sourcing strategy, derived from the category sourcing strategy\n- Supplier Selection: evaluate and negotiate proposals, ensure and validate selection of best supplier\n- Supplier Contracting: Complete and implement the contract in accordance with legal standards and Procurement policies and guidelines\n\n\u2022 Category Management:\n- Monitor, analyze and report Affiliate\u2019s actual spend, trends, forecasts and supplier base data\n- Participate in International category strategy development and in International Sourcing teams\n- Support Strategic Sourcing infrastructure development and integration\n\n\u2022 Purchase to pay:\n- Assist and monitor the operational purchase to pay process for the Affiliate and ensure conformance to procurement process policies and guidelines\n\n\u2022 Supplier Performance:\n- Monitor and report supplier performance on the basis of pre-determined, relevant and measurable Key Performance Indicators (KPIs) and establish, agree and implement improvement plans\n\n\u2022 Reporting:\n- Benefits Tracking: develop, maintain and report KPIs that clearly reflect the achievement of objectives in each business area\n\nThe jobholder reports to the International Head of Category Management in Switzerland with a dotted-line to the local Director Finance.\nBasic Qualifications - Bachelor\u2019s degree in appropriate discipline (technical/economic/administrative) or equivalent\n\nExperience and Knowledge\n- Ideally at least 5 years experience in a profit driven and international dynamic environment with indirect materials\n- Purchasing knowledge: sourcing process, commodity management and analysis, supplier management and development, pricing theory and policy, negotiation, supply chain, make or buy\n- Experience with tendering processes, supplier negotiations and contracting including eSourcing\n- Project Management experience\n- Fluency in local language and English (both in oral and written communication)\n- Excellent computer skills (MS office, esp. Excel/Powerpoint) and experience with ERP (SAP)\n\nKey Competencies\n- Analytical and conceptual thinking\n- Ability and demonstrated experience in leading change programs\n- Financial and Business Acumen, Results orientation\n- Excellent negotiation, communication and presentation skills, Leadership skills\n- Self-starting, assertiveness\n- Familiar with working in a matrix organization\n- Ability to engage prople and proactively build up trustful relationships and cooperations\nPreferred Qualifications We offer the opportunity to develop your career within one of the most innovative and successful companies worldwide, not only to develop your technical skills but also to grow your personality and competencies too. You will find an open and success oriented working environment. Attractive conditions and social benefits are part of our people concept.\n\nTo upload your application and for further information about AMGEN we invite you to visit our career center on our homepage www.amgen.com. Please upload your application to Req.-No. 14188BR or follow the respective link.\n\nIn case you have any questions please contact Martina Rech \u2013 Staffing Manager, Phone Number +49 89 14 90 96-1112.", "date_new": "2012-03-05 21:20:19", "url": "http://www.amgen.jobs/xml/26933430/job", "country": "Germany", "company": "Amgen", "title": "Strategic Sourcing Senior Manager", "reqid": "14188BR", "state": null, "state_short": null, "location": "Munich, DEU", "uid": 26933430}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14036BR\nJob Posting Title Sr Mgr Manufacturing - Maintenance Packaging\nCareer Category Maintenance\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Sr. Manager Manufacturing \u2013 Maintenance Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will report to the Director of Manufacturing & Operations \u2013 Packaging. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations \u2013 Packaging area. Previous experience with maintaining packaging line equipment is a distinct advantage. Working knowledge of equipment from various vendors would also be advantageous.\n\nKey Responsibilities:\n\n\u2022 Manage the Maintenance of the all the Packaging Equipment within the syringe facility while ensuring Manufacturing smooth and consistent running of all equipment in the Packaging facility which has isolator technology.\n\u2022 Strong operating knowledge of pharmaceutical GMP\u2019s and their application to the maintenance function.\n\u2022 Lead in the development of Manufacturing\u2019s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.\n\u2022 Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment.\n\u2022 Support the plant in the project approval, prioritization, and implementation process.\n\u2022 Develop metrics to support the benchmarking of site, global, and industry.\n\u2022 Develop improvement strategies across the Maintenance function.\n\u2022 Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department.\n\u2022 Assure the appropriate level of training is undertaken for all levels of the Maintenance organization which may involve developing training material.\n\u2022 Responsible for attaining and improving site based metrics targets.\n\u2022 Responsible for recruiting talented staff into Maintenance and setting standards for their performance.\n\u2022 This position will need to complete some travel to the other Amgen sites over the next two years.\n\n* Other functions may be assigned.\nBasic Qualifications Basic Qualifications\n\n\u2022 Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff.\n\u2022 Bachelor\u2019s Degree or combination of education and/or years of experience.\n\u2022 Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable.\nPreferred Qualifications Preferred Qualifications#\n\n\u2022 Knowledge of conflict resolution\n\u2022 Ability to partner with other departments.\n\u2022 Analytical problem solving.\n\u2022 Considerable Organization skills.\n\u2022 Experience in coaching, mentoring and counselling.\n\u2022 Ability to deal with and manage change.\n\u2022 Ability to set goals.\n\u2022 Knowledge of applicable regulatory guidelines\n\u2022 Ability to use company compensation system including mentoring lower management levels when required.\n\u2022 Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-03-03 20:26:16", "url": "http://www.amgen.jobs/xml/26910351/job", "country": "Ireland", "company": "Amgen", "title": "Sr Mgr Manufacturing - Maintenance Packaging", "reqid": "14036BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910351}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14027BR\nJob Posting Title Director Manufacturing - Operations & Packaging\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Director Manufacturing \u2013 Operations & Packaging\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis role will report into the Executive Director Manufacturing and will be responsible for the management of the packaging manufacturing operations, over 4 lines and 2 work centres, at Amgen Dun Laoghaire. The successful Candidate will be responsible for maintenance of the facility, building of the packaging organisation and ensuring the on time delivery of GMP product in a safe and cost effective manner.\nKey Responsibilities:\n\n\u2022  Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage.\n\u2022 Ensure that the Manufacturing \u2013 Operations & Packaging area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department.\n\u2022 Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture.\n\u2022 A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage.\n\u2022 Develop and maintain an effective organisation through selection, teaching, leadership and development Management.\n\u2022 Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities.\n\u2022 Experience of operations with both high mix and high volume, plus experience with different equipment manufacturers and packaging configurations.\n\u2022 Detailed experience relating to line integration.\n\u2022 The ability to specify the appropriate levels of automation to optimize line efficiency and output quality.\n\u2022 Experience with eliminating glass defects in vials and syringes during packaging operations.\n\u2022 Experience with packaging facility start up and tech transfer programs between different facilities.\n\u2022 Ensure effective two-way communication within the plant, with peers and groups internally and externally.\n\u2022 The ability to adopt a hand\u2019s on approach during start up and commissioning phase.\n\u2022 The capability to undertake significant travel for vendor visits and FAT\u2019s.\n\u2022 Responsibility for maintaining Amgen\u2019s performance management system within the packaging area.\nBasic Qualifications Basic Qualifications:\n\u2022 Degree in Engineering or Science, with a background in manufacturing, quality, process development.\n\u2022 10-15 years experience in managing significant packaging operations in a GMP environment.\n\n\u2022 Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs.\nPreferred Qualifications Preferred Qualifications:\n\n\u2022 BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD)\n\u2022 Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects\n\u2022 Strong technical skills related to scale up\n\u2022 Thorough knowledge of GMP biotechnology manufacturing\n\u2022 Solid understanding and knowledge of cGMPs\n\u2022 Awareness and understanding of quality and regulatory industry trends, policies and guidelines\n\u2022 Proven track record of advancement in an established, high performing organization\n\u2022 Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs\n\u2022 Excellent project management skills with the ability to lead effectively in an highly matrixed organization\n\u2022 Excellent communication skills able to work with and influence executive management\n\u2022 Strong understanding of validation of biopharmaceutical facilities, equipment and process\n\u2022 Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately", "date_new": "2012-03-03 20:25:43", "url": "http://www.amgen.jobs/xml/26910344/job", "country": "Ireland", "company": "Amgen", "title": "Director Manufacturing - Operations & Packaging", "reqid": "14027BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910344}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14041BR\nJob Posting Title Sr Mgr Manufacturing - Maintenance Syringe\nCareer Category Maintenance\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Sr. Manager Manufacturing \u2013 Maintenance Syringe\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis position will report to the Director of Manufacturing & Operations \u2013 Syringe. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations \u2013 Syringe area. Previous experience in maintaining syringe manufacturing and inspection equipment is a distinct advantage. Experience with the use and maintenance of isolator equipment would also be advantageous.\n\nKey Responsibilities:\n\n\u2022 Manage the smooth and consistent running of all equipment in the Syringe facility which has isolator technology.\n\u2022 Strong operating knowledge of pharmaceutical GMP\u2019s and their application to the maintenance function.\n\u2022 Lead in the development of Manufacturing\u2019s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals.\n\u2022 Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment.\n\u2022 Support the plant in the project approval, prioritization, and implementation process.\n\u2022 Develop metrics to support the benchmarking of site, global, and industry.\n\u2022 Develop improvement strategies across the Maintenance function.\n\u2022 Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department.\n\u2022 Assure the appropriate level of training is undertaken for all levels of the Maintenance- Syringe organization which may involve developing training material.\n\u2022 Responsible for attaining and improving site based metrics targets.\n\u2022 Responsible for recruiting talented staff into Maintenance \u2013 Syringe and setting standards for their performance.\n\u2022 This position will need to complete some travel to the other Amgen sites over the next two years.\n\n* Other functions may be assigned.\nBasic Qualifications Basic Qualifications\n\n\u2022 Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff.\n\u2022 Bachelor\u2019s Degree or combination of education and/or years of experience.\n\u2022 Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable.\nPreferred Qualifications Preferred Qualifications#\n\n\u2022 Knowledge of conflict resolution\n\u2022 Ability to partner with other departments.\n\u2022 Analytical problem solving.\n\u2022 Considerable Organization skills.\n\u2022 Experience in coaching, mentoring and counselling.\n\u2022 Ability to deal with and manage change.\n\u2022 Ability to set goals.\n\u2022 Knowledge of applicable regulatory guidelines\n\u2022 Ability to use company compensation system including mentoring lower management levels when required.\n\u2022 Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.", "date_new": "2012-03-03 20:25:23", "url": "http://www.amgen.jobs/xml/26910341/job", "country": "Ireland", "company": "Amgen", "title": "Sr Mgr Manufacturing - Maintenance Syringe", "reqid": "14041BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910341}, {"country_short": "IRL", "city": "Dun Laoghaire", "description": "Auto req 14028BR\nJob Posting Title Dir Manufacturing - Syringe\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dun Laoghaire\nAmgen Job Description Director Manufacturing - Syringe\n\nAmgen Dun Laoghaire - Dublin\n\nOverview:\n\nThis role will report into the Executive Director Manufacturing and will be responsible for the manufacturing of syringes at the Amgen Dun Laoghaire Site. The successful candidate will be responsible for the maintenance of the facility and for building an organization that ensures on time delivery of GMP product in a safe and cost effective manner.\n\nKey Responsibilities:\n\n\u2022  Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage.\n\u2022 Ensure that the Manufacturing \u2013 Syringe area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department.\n\u2022 Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture.\n\u2022 A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage.\n\u2022 Develop and maintain an effective organisation through selection, teaching, leadership and development Management.\n\u2022 Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities.\n\u2022  Experience with syringe facility start up and tech transfer programs between different facilities.\n\u2022 Experience of syringe inspection operations with previous experience of training of staff in this area an advantage.\n\u2022 Detailed experience relating to all aspects of line integration.\n\u2022 A detailed understanding of the automation requirements necessary to optimize line efficiency and output quality.\n\u2022 Experience with eliminating glass defects in syringes during filling and inspection operations.\n\u2022 Prepares and submit annual expenditure budgets and monitor actual performance against these budgets, taking corrective action where necessary\n\u2022 Ensure effective two-way communication within the plant, with peers and groups internally and externally.\n\u2022 The ability to adopt a hand\u2019s on approach during start up and commissioning phase.\n\u2022 The capability to undertake significant travel for vendor visits and FAT\u2019s.\n\u2022 Responsibility for maintaining Amgen\u2019s performance management system within the syringe filling area.\nBasic Qualifications Basic Qualifications:\n\n\u2022 Degree educated with significant relevant experience\n\u2022 Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs.\nPreferred Qualifications Preferred Qualifications:\n\n\u2022 BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD)\n\u2022 Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects\n\u2022 Strong technical skills related to scale up\n\u2022 Thorough knowledge of GMP biotechnology manufacturing\n\u2022 Solid understanding and knowledge of cGMPs\n\u2022 Awareness and understanding of quality and regulatory industry trends, policies and guidelines\n\u2022 Proven track record of advancement in an established, high performing organization\n\u2022 Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs\n\u2022 Excellent project management skills with the ability to lead effectively in an highly matrixed organization\n\u2022 Excellent communication skills able to work with and influence executive management\n\u2022 Strong understanding of validation of biopharmaceutical facilities, equipment and process\n\u2022 Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately", "date_new": "2012-03-03 20:24:47", "url": "http://www.amgen.jobs/xml/26910336/job", "country": "Ireland", "company": "Amgen", "title": "Dir Manufacturing - Syringe", "reqid": "14028BR", "state": null, "state_short": null, "location": "Dun Laoghaire, IRL", "uid": 26910336}, {"country_short": "GBR", "city": "Uxbridge", "description": "Auto req 14152BR\nJob Posting Title Corporate Communications Senior Mgr\nCareer Category Marketing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Uxbridge\nAmgen Job Description Overview:\n\nThe jobholder will be accountable for the development and implementation of a UK-wide internal communications plan to include staff engagement strategies and activities; International R&D messaging; audience insights; use of appropriate channels; communication programs into global R&D and the International Organisation.\n\nThe jobholder will lead and manage assigned International projects and provide internal and change communications counsel to key assigned internal stakeholders\n\n\nKey Responsibilities:\n\n- Apply a solid understanding of the business and assigned client goals and priorities, as well as the issues clients face locally, to provide effective communications guidance and recommendations.\n- Develop and support implementation of UK-wide staff engagement and communications plan\nServe as a member of the ALMT, flagging new developments, opportunities, threats, making recommendations and sharing best practice.\n- Partner closely with R&D executives, HR and affiliate leadership, as well as affiliate communicators, to ensure internal/ external and business alignment\n- Facilitate effective relationships between different functions in UK on all relevant communications activities.\n- Serve as single point of contact for Global Communications and client groups requiring UK or assigned functional and regional support.\n- Provide insights/ updates to the Global R&D communications team to ensure that IRD is better understood and integrated into global functional communications.\n- Ensure IRD is adequately represented and addressed in International (regional) communications.\n- Develop and manage local internal communications infrastructure and tools.\n- Build and sustain relationships with key internal stakeholders.\n- Develop and support implementation of internal communications plans consistent with Amgen\u2019s global, functional and International communications strategies, and aligned with local/ functional/ regional objectives.\nBasic Qualifications - Bachelor's Degree in English, Journalism, Communications or the equivalent combination of education and experience\nPreferred Qualifications Experience and Skill:\n\n- Relevant experience and proven track record in international corporate communications, ideally gained in pharmaceutical or healthcare; agency experience a plus\n- Broad communications experience, with depth in internal communications and change management\n- Demonstrated business acumen, and proven track record of advising executives and leadership\n- Ability to select, engage and manage a public relations firm\n- Outstanding oral, written and presentation skills\n- Strategic approach to communications and program development\n- Excellent written and verbal command of English (mother tongue preferred); proficiency in other languages an advantage\n\nKnowledge:\n\n- Knowledge of pharmaceutical/ biotech industry\n- Knowledge of digital and interactive media and how to apply it to internal communications\n- Cultural understanding\n- Knowledge of change management", "date_new": "2012-03-02 18:38:02", "url": "http://www.amgen.jobs/xml/26890895/job", "country": "United Kingdom", "company": "Amgen", "title": "Corporate Communications Senior Mgr", "reqid": "14152BR", "state": null, "state_short": null, "location": "Uxbridge, GBR", "uid": 26890895}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14117BR\nJob Posting Title Principle Scientist - Plastics, Product and Process Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This high level position for a subject matter expert within the Product and Process Engineering Organization is responsible for providing scientific and technical leadership and strategic direction to the evaluation of designated raw materials, in this case plastics used in single use biopharmaceutical applications, and their potential impact on product quality and process performance. REsponsible to assess the impact of changes in materials or manufacturing processes.\n\nThis individual will be responsible for assessing supplier capabilities, technical competences and understanding of the needs of biopharmaceutical manufacturers along with other team members. The successful candidate will support or lead cross-functional teams of experienced scientists and engineers through project challenges and mentor them in the selection of the most appropriate materials and technologies. The candidate will actively chart the course and translate business strategies into challenging, actionable objectives and plans, and will apply meaningful metrics for projects, personnel and other resources.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 PhD in materials science with specialization in polymers, or multiple years in the manufacture of pharmaceutical plastics\n\u2022 Ten years relevant work experience in use of plastics materials in biopharmaceutical applications\n\u2022 Knowledge of license applications and the drug development process\n\u2022 Familiarity with all aspects of the use of plastics in biopharmaceutical applications, current state of the art technologies and emerging scientific directions.\n\u2022 Leadership experience of progressively increased scope.\n\u2022 Strong interdisciplinary project management skills.\n\u2022 Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.\n\u2022 Should be recognized in the scientific community and supplier base through a sustained record of publications and patents.\n\u2022 Should have strong communication skills, both written and oral. He/she must network and build solid working relationships across departments, with diverse and remote staff and with external collaborators from key suppliers.\n\u2022 Ability to think and operate strategically, as well as formulate, write, present and execute well-designed strategies and plans.\n\u2022 Team leadership, management, and facilitation skills are required.\nShould be willing to travel (approx 30%) to other Amgen sites and/or support supplier technical assessments or audits at short notice domestically and overseas.\n\u2022 Extensive knowledge of the manufacturing processes, usage, regulatory requirements, practices, scientific properties and risks associated with the raw materials for pharmaceutical and biological products.", "date_new": "2012-03-02 18:37:59", "url": "http://www.amgen.jobs/xml/26890893/job", "country": "United States", "company": "Amgen", "title": "Principle Scientist - Plastics,  Product and Process Engineering", "reqid": "14117BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26890893}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14072BR\nJob Posting Title Sr Associate Mfg\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Under minimal supervision, the Sr. Associate, Mfg, will routinely perform complex to critical processes according to Standard Operating Procedures in the Manufacturing area, specifically the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, with focus in the operation of automated fill equipment inside the aseptic environment. The individual will support and/or be responsible for the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions for the aseptic filling process. The individual will need to apply process, operational expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Candidates should have strong computer skills, GMP knowledge, cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures.\n\n\u2022 Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.\n\u2022 Evaluate, plan, and implement solutions for process improvement opportunities.\n\u2022 Provide troubleshooting support.\n\u2022 Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.\n\u2022 Assist with managing investigation closure within established goal.\n\u2022 Assist with equipment/system Root Cause Analysis investigations and support trend evaluations.\n\u2022 Participate in the New Product Introduction process to assess requirements for documentation, materials, training, and equipment modifications.\n\u2022 Assist manufacturing change owner on Change Control packages impacting the process.\n\u2022 Train operations personnel on new processes or changes to process\n\u2022 Assist with overseeing engineering studies\n\u2022 Prepare, review, approve, and provide technical support for preparation and execution of relevant technical documents, as required.\nBasic Qualifications \u2022 Master\u2019s degree\nOR\n\u2022 Bachelor\u2019s degree & 2 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 6 years of directly related experience\nOR\n\u2022 High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications \u2022 Bachelor\u2019s degree in Mechanical Engineering with 2 or more years of experience in biopharma.\n\u2022 Demonstrated ability organizing and leading projects\n\u2022 Experience working within biopharma formulation and filling of parenteral products\n\u2022 Clear understanding of cGMPs.\n\u2022 Strong computer skills.\n\u2022 Strong cross functional communication\n\u2022 Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height.\n\u2022 Knowledge of aseptic, barrier (RABs), or isolator technology for parenteral filling operations.\n\u2022 Experience working hands on with equipment and processes and to train other technical staff and operators.", "date_new": "2012-03-01 23:11:26", "url": "http://www.amgen.jobs/xml/26874101/job", "country": "United States", "company": "Amgen", "title": "Sr Associate Mfg", "reqid": "14072BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26874101}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14067BR\nJob Posting Title Associate Mfg\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Under minimal supervision, an Associate, Mfg, will routinely assist in performing complex to critical processes according to Standard Operating Procedures in the Manufacturing area. Individual will be responsible for the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, primarily operation of automated fill equipment inside the aseptic environment. Candidates should understand basic computer skills, have GMP knowledge, good cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures.\n\nWill need to be available to work non-standard shifts, evenings and/or weekends.\n\nMajor duties will include:\n\u2022 Operation of the fill/stoppering equipment to dispense sterile product into glass containers\n\u2022 Environmental monitoring of the aseptic environment during each fill and after each fill\n\u2022 Loading and unloading of sterile products from freeze dryers\n\u2022 Operation of the continuous particulate monitoring system during each fill\n\u2022 Assembling and disassembling of equipment before and after use\n\u2022 Performing operations during fills by following proper procedures\n\u2022 High levels of housekeeping to conform to cGMP standards\n\u2022 Cleaning and sanitizing aseptic filling areas to maintain the quality of the product\n\u2022 Detailed and accurate documentation in batch production records.\n\u2022 Able to determine availability of components and assign accordingly.\n\u2022 May also be required to assist in training of co-workers.\n\u2022 Able to perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques.\nBasic Qualifications \u2022 Bachelor\u2019s degree\nOR\n\u2022 Associate\u2019s degree & 4 years of directly related experience\nOR\n\u2022 High school diploma / GED & 6 years of directly related experience\nPreferred Qualifications \u2022 Bachelors Degree in Mechanical Engineering, or Technology.\n\n\u2022 Exposure to aseptic filling, biopharma manufacturing equipment, trouble shooting and moving machinery.\n\u2022 Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses.\n\u2022 cGMP manufacturing experience including mechanical ability/expertise.\n\u2022 Demonstrate technical writing capability.\n\u2022 Demonstrate project management skills, presentation skills, and be able to independently collaborate with outside resources.", "date_new": "2012-03-01 23:11:11", "url": "http://www.amgen.jobs/xml/26874098/job", "country": "United States", "company": "Amgen", "title": "Associate Mfg", "reqid": "14067BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26874098}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14150BR\nJob Posting Title Principal Scientist (Quantitative Pharmacology/PKDM)\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department.\n\nThe Principal Scientist will be the PKDM Development Project Team Representative on the Early and/or Global Development Teams in the area of Oncology. He/she will support small and large molecule drug development, registration, and post-marketing activities. He/she will be responsible for program-level strategic and resource planning, communication, scientific/technical deliverables, issue resolution, and functional representation for Amgen internal governance reviews, face-to-face interactions with global regulatory authorities, and external scientific communities. The individual will effectively lead PKDM Development Project Team, and interface with internal business stakeholders (such as Clinical Development, Early Development, Biostatistics, Regulatory Affairs, Research, Toxicology, etc.). This PKDM Development Project Team Reprehensive will be responsible for the PK, PK/PD, and Modeling & Simulation strategy in the Early and Global Development Teams, prepare regulatory documents as a PK/PD expert, and represent Amgen PKDM Department in the global regulatory interactions. Development of junior members and interaction with the line-management will also be key responsibilities.\nBasic Qualifications - Doctorate degree & 5 years of scientific experience\nOR\n- Master\u2019s degree & 12 years of scientific experience\nOR\n- Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications - PhD (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training is required\n- Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s) in Oncology with working knowledge in bioanalytical and drug metabolism\n- Experience in PK/PD modeling and population-based analyses/simulations (e.g. hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc) and PK analysis (e.g. proficiency in WinNONLIN)\n- Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities\n- Leadership quality for effective team building with strong decision making and problem solving skills\n- Excellent interpersonal, technical, and communication skills that enable effective management and resolution of complex issues involving collaborations within a cross-functional team setting\n- Project management skills for timeline tracking and resource planning\n- Comprehensions in R&D processes for small molecules and/or protein therapeutics. General understanding in biology (mechanism of action)/pharmacology, toxicology, clinical immunology, protein sciences, statistics, pharmaceutics, and clinical development, etc.", "date_new": "2012-02-29 22:31:16", "url": "http://www.amgen.jobs/xml/26849248/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist (Quantitative Pharmacology/PKDM)", "reqid": "14150BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26849248}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 14154BR\nJob Posting Title Director Preclinical (Quantitative Pharmacology/PKDM)\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Washington\nLocation (City) Seattle\nAmgen Job Description Amgen, Inc. is seeking a highly motivated candidate for the position of Director in the Quantitative Pharmacology Group of the PKDM Department.\n\nThe Director will provide strategic vision and portfolio leadership in support of small and large molecule drug development, registration, and/or post-marketing activities. He/she will be responsible for portfolio-level strategic and resource planning, communication, scientific/technical deliverables, and issue resolution. A key focus will be to serve as functional representation for Amgen internal governance reviews and external scientific and regulatory communities including face-to-face interactions with global regulatory/health authorities.\n\nThe individual will interface with internal business stakeholders (such as Research, Toxicology, Early Development, Clinical Development, Biostatistics, CMC, Regulatory Affairs, etc.). The candidate will mentor and advise a group of project team representatives at all stages of discovery and clinical development and implement advanced modeling & simulation (M&S) strategies across the portfolio to influence decision making. The individual will be responsible for the development of key operational efficiencies and new technologies within the quantitative pharmacology group.\nBasic Qualifications - Doctorate degree & 7 years of scientific experience\nPreferred Qualifications - PhD in Pharmacokinetics, Pharmaceutical Sciences, or with equivalent professional degrees (e.g. MD, PharmD) with 10 years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training\n- Experience as PKDM/Clinical Pharmacology functional representative on product development teams\n- Experience with PK and PK/PD data analysis, interpretation, and reporting for small molecule and/or protein therapeutics\n- Hands-on experiences in population PK/PD modeling and simulations (M&S)\n- Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities\n- R&D experience in oncology therapeutics, inflammation and/or metabolic therapeutic areas\n- Leadership quality for effective team building with strong decision making and problem solving skills\n- Excellent interpersonal, technical, and communication skills to lead a group of quantitative pharmacology scientists\n- Excellent problem scoping, planning and business skills necessary to drive decision making and influence senior leadership\n- Project management skills for timeline tracking and resource planning\n- Solid publication record as senior author and growing reputation with external peers.\n- The successful candidate will have strong interpersonal communication and leadership skills.", "date_new": "2012-02-29 22:30:57", "url": "http://www.amgen.jobs/xml/26849234/job", "country": "United States", "company": "Amgen", "title": "Director Preclinical (Quantitative Pharmacology/PKDM)", "reqid": "14154BR", "state": "Washington", "state_short": "WA", "location": "Seattle, WA", "uid": 26849234}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14148BR\nJob Posting Title Sr Scientist (Quantitative Pharmacology/PKDM)\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Senior Scientist in the in the Quantitative Pharmacology Group of Pharmacokinetics and Drug Metabolism (PKDM) Department.\n\nThe Senior Scientist will serve as a PK/PD expert to support early and late development programs in various therapeutic areas (e.g. Neurosciences, Cardiovascular, or other therapeutic areas). The individual will effectively interface within the PKDM department and with external functions (such as Early Development, Clinical Development, Biostatistics, Statistical Programming, Clinical Data Management, Regulatory Affairs, etc.). The successful candidate will develop PK/PD strategy, perform modeling & simulation analyses and report writing, and prepare regulatory document sections as appropriate. This individual may also serve as a PKDM Development Project Team Reprehensive who will be responsible for the PK, PK/PD, and Modeling & Simulation strategy in the Early and Global Development Teams, prepare regulatory documents as a PK/PD expert, and represent Amgen PKDM Department in the global regulatory interactions. Development of junior members and interaction with the line-management will also be key responsibilities.\nBasic Qualifications - Doctorate degree & 2 years of scientific experience\nOR\n- Master\u2019s degree & 8 years of scientific  experience\nOR\n- Bachelor\u2019s degree & 10 years of scientific experience\nPreferred Qualifications - PhD (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 3+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training is required\n- Specialized in PK/PD modeling and population-based analyses/simulations (hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc).\n- Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s)\n- Excellent interpersonal, scientific, technical, and communication skills that enable effective management and resolution of complex, project-related issues involving multiple functional areas and levels of management.\n- Knowledge of PK and PK/PD for small molecule and/or protein therapeutics.\n- Leadership quality for effective team building with strong decision making and problem solving skills\n- Experience in authoring regulatory documentation (IND, IMPD, CTX, etc) and interaction with regulatory authorities.\n- Experience as PK/PD lead on discovery or development project teams in Neurosciences, Cardiovascular, or other therapeutic areas.", "date_new": "2012-02-29 22:30:55", "url": "http://www.amgen.jobs/xml/26849231/job", "country": "United States", "company": "Amgen", "title": "Sr Scientist (Quantitative Pharmacology/PKDM)", "reqid": "14148BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26849231}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14057BR\nJob Posting Title Principal IS Automation Engineer\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role will act as the Operations Information Systems (OIS) automation project leader for site projects including expansions and upgrade activities. The individual will build consensus between the individual requirements of facility management, Corporate Engineering, OIS, and corporate standard architectures to design the project specific automation architecture for project activities. Key Accountabilities: \u2022 Automation Project Leader for site projects including expansions and upgrade activities, providing day to day technical leadership to the project team in all project phases (design, delivery, startup, commissioning, validation and operational support \u2022 Ensure the project budget, schedule and staffing is commensurate to enabling the Process Control Systems (PCS), Manufacturing Execution Systems (MES), Building Automation Systems (BAS), and Plant Information Systems to attain the performance standards required to support the business objectives. \u2022 Act as client interface, point of escalation and resolve client concerns, developing and reporting project results, technical guidance of a project from concept to delivery, detailed project planning, management of suppliers/contractors/Systems integrators/OEMs, system commissioning and validation, technical solution evaluation, schedule tracking. \u2022 Lead and manage staff, the jobholder will direct the activity of others in matrix, internal or external reporting relationships \u2022 Build strong relationships with stakeholders, contribute to key decision making and influence the development of business area strategy where appropriate. \u2022 Operational vendor management and contract negotiations with focus on Automation Systems Integrators and OEM suppliers. \u2022 Ensuring compliance with practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies, develop supporting documentation and monitor budget tracking/ timeliness/ scheduled resources.\nBasic Qualifications Doctorate degree & 2 years of directly related experience OR Master\u2019s degree & 6 years of directly related experience OR Bachelor\u2019s degree & 8 years of directly related experience OR Associate\u2019s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ability to translate strategic opportunities within biopharma and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements. \u2022 Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical, project management, and business expertise. \u2022 Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies to establish a PCS, BAS, and MES implementation and Systems Integration that meets Operations' business requirements. \u2022 Experience with Rockwell Automation PLC/SCADA/Batch, Emerson DeltaV, OSIsoft PI Data Historian, Werum MES and Siemens BAS is preferred. \u2022 Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.", "date_new": "2012-02-29 22:30:20", "url": "http://www.amgen.jobs/xml/26849217/job", "country": "United States", "company": "Amgen", "title": "Principal IS Automation Engineer", "reqid": "14057BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26849217}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14147BR\nJob Posting Title Clinical Research Sr Medical Scientist - Cardiology\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Research Sr. Medical Scientist is responsible for:\n\n- Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Participating and providing clinical input into safety and regulatory interactions\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols)\n- Interpret clinical trial data\n- Participate in safety assessments\n- Review and provide clinical scientific input to TLGs and safety narratives\n- Review scientific literature\n- Initiate database analyses to support commercial/clinical objectives\n- Contribute to the preparation of clinical study reports and regulatory submissions\n- Participate in interactions with regulatory agencies\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL\n- Identify new clinical research opportunities\n\nKnowledge:\n\n- Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Medical knowledge in the relevant therapeutic area\n- Sound scientific and clinical judgment\n- Familiarity with regulatory agency organization, guidelines, and practices\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues\nBasic Qualifications M.D. degree\nPreferred Qualifications - M.D. plus accredited residency in Cardiology, board certified or equivalent\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities", "date_new": "2012-02-29 22:29:59", "url": "http://www.amgen.jobs/xml/26849201/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Sr Medical Scientist - Cardiology", "reqid": "14147BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26849201}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14074BR\nJob Posting Title Dir Engineering - Human Factors and Industrial Design - Drug Delivery\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The successful Director of Human Factors and Industrial Design Engineering (HF/ID) will lead human factors and industrial design activities for development of Amgen drug delivery devices/systems taking into consideration all aspects of the user, the intended use, the use environment (eco-system), and the drug therapy being delivered. The Director will collaborate with marketing, engineering, quality, manufacturing and regulatory team members to create innovative and intuitive-to-use products through the application of human-centered design methodologies through Usability assurance, determination of desired user profiles, development of user documentation, and development of training programs.\nThe Director will partner with marketing to lead internal and external team activities that assure brand driven aesthetics are applied consistently across the entire product portfolio.\nThe successful candidate will be responsible for independently leading the planning, execution and reporting of human factors engineering, user interface and industrial design studies across all device programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries. The Director HF/ID will ensure that expert HF/ID input is provided to device design teams for establishing design requirements, packaging requirements, training requirements and use instructions. The Director HF/ID will ensure that HF/ID expertise is applied to create and complete design validation activities and clinical studies in support of regulatory submissions. Further, the Director HF/ID will ensure that human factors engineering concepts are incorporated early in the development process based on industry best practices. The Director HF/ID will act as a key advocate for these principles across Amgen.\nEnsures\n\u2022 Human-system capabilities and limitations are properly reflected in the system requirements\n\u2022 Human-system performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs)\n\u2022 Human-system performance and safety risks are appropriately addressed in program baseline\n\u2022 Determine the human factors cost, benefit, schedule, and performance baselines for each candidate solution\n\u2022 Identify the human factors and human performance measures and thresholds to be achieved (e.g., for the equipment, software, environment, support concepts, and configurations expected for the solution)\n\u2022 Determine the human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred\n\u2022 Calculate or estimate the relative or absolute benefits of the human factors component of each solution in terms of decision criteria (e.g., cost, schedule, human-system performance\n\nThe position requires excellent organizational, technical problem solving and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead external design consultants.\nBasic Qualifications \u2022 Doctorate degree & 4 years of applied HF/ID engineering experience\nOR\n\u2022 Master\u2019s degree & 8 years of applied HF/ID engineering experience\nOR\n\u2022 Bachelor\u2019s degree & 10 years of applied HF/ID engineering experience\nAND\n\u2022 4 years of engineering managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications \u2022 Bachelor's degree in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments.\n\u2022 MS in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline\n\u2022 Certified Professional Ergonomist (CPE), Certified Human Factors Professional (CHFP), Certified User Experience Professional (CUXP), Associate Ergonomics Professional (AEP), Associate Human Factors Professional (AHFP), Associate User Experience Professional (AUXP) or Certified Ergonomics Associate (CEA).\n\u2022 Minimum of 8+ years experience working in the development of electro-mechanical systems design, verification and validation\n\u2022 Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools\n\u2022 Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected\n\u2022 Experience with complex, cross-functional development projects\n\u2022 Experience working with and leading cross-cultural teams\n\u2022 Proven ability to apply situational leadership concepts across various intra and inter-departmental matters\n\u2022 Demonstrated time management, decision making, presentation and organization skills\n\u2022 Previous experience in HF/ID engineering and commercialization process with drug delivery devices and combination drug/device products is desired\n\u2022 HF/ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal)\n\u2022 Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines\nThe position requires also requires the following:\n\u2022 Proven experience in the HF/ID principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis\n\u2022 Proven experience with using sketch models, low and high fidelity prototypes to identify and eliminate potential use errors early in the development process\n\u2022 Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market\n\u2022 Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction\n\u2022 Thorough knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging\n\u2022 Good understanding of the principles of Medical Device and healthcare regulations including FDAs Quality System Regulation (QSR), ISO 13485:2003, 14971, EN 60601, Council Directive 93/42/EEC, etc.\n\u2022 Experience in design of formative and summative human factor studies to address the needs of the requirements setting, design testing, verification and validation stages of medical device development\n\u2022 Experience in writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports)\n\u2022 Proven leadership and experience managing multiple projects with high demand schedules\n\u2022 Experience in management of external partners\n\u2022 Experience with establishing departmental or program objectives following company policies and establishing procedures that are measureable with outcomes can be quantified", "date_new": "2012-02-25 18:46:50", "url": "http://www.amgen.jobs/xml/26756596/job", "country": "United States", "company": "Amgen", "title": "Dir Engineering - Human Factors and Industrial Design - Drug Delivery", "reqid": "14074BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26756596}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 14023BR\nJob Posting Title Sr Scientist - Pharmaceutics\nCareer Category Scientific\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nAmgen Job Description The position responsibilities include independently designing and conducting preformulation characterization of small molecules, developing formulations to support in-vivo animal studies, solid state characterization and salt and form selection for clinical candidate. The position responsibilities also include developing small molecule parenteral formulation for clinical use. A successful candidate will participate and represent pharmaceutics in a multi-disciplinary team, supervising scientific projects, providing critical evaluation of scientific data and results, and providing technical mentoring and expertise to associate level staff.\nBasic Qualifications Doctorate degree & 2 years of scientific experience\nOR\nMaster\u2019s degree & 8 years of scientific experience\nOR\nBachelor\u2019s degree & 10 years of scientific experience\nPreferred Qualifications A Ph.D. in Pharmaceutical Chemistry, Physical Chemistry, Physical Organic Chemistry, Organic Chemistry, or scientific field\n3+ years of relevant post doctoral and industrial experience.\nA thorough understanding of basic pharmaceutics such as solubility, physicochemical properties, and chemical stability.\nExperience in developing small molecule parenteral clinical formulation as well as an understanding and familiarity with the solid-state characterization techniques (DSC, TGA, XRPD, microscopy, moisture uptake, HPLC etc).\nGood communication skills (oral and written), good computer skills, and problem solving skills are required.", "date_new": "2012-02-24 19:34:10", "url": "http://www.amgen.jobs/xml/26740014/job", "country": "United States", "company": "Amgen", "title": "Sr Scientist - Pharmaceutics", "reqid": "14023BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 26740014}, {"country_short": "GBR", "city": "Cambridge", "description": "Auto req 13694BR\nJob Posting Title Sr Associate IS Bus Sys Analyst\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Cambridge\nUxbridge\nAmgen Job Description Overview:\n\nThe jobholder will provide technical support and leadership across International Drug Safety functions, developing, maintaining and operating new and existing services whilst meeting Information Systems (IS) technical standards and business requirements. Relevant domain experience of Drug Safety business processes and technologies will be strongly favoured.\n\nKey Responsibilities:\n\n\u2022 Provide technical 2nd and 3rd line support for Amgen Business Applications\n\u2022 Provide co-ordination of major incidents relating to Safety applications support where required\n\u2022 Intake of all Global Safety change requests related to Regulatory Reporting Rules and E2B requirements, analysis with business to clarify requirements , prioritise and track status and progress through to implementation\n\u2022 Participate in the end-to-end Change Management process for Reporting Rules requests inclusive of CAB approvals, change owner tasks, writing & executing validation documentation and production of release notes\n\u2022 Provide operational direction and support for Global Safety Adverse Event intake channels (fax, e-mail, telephone etc.) across all global Amgen affiliates\n\u2022 Liaise with business to define requirements and internal IS functions on development, testing and implementation of Safety related enhancements for the Adverse Event Intake system\n\u2022 Provide International IS assistance to the Pharmacovigilance Legislation core team to assess technical impacts of new legislation on Safety systems and feedback into Global Safety IS team\n\u2022 Provide support to International Safety IS Business Partner as required in areas including representation at internal customer and cross functional IS Business Partner meetings, internal and external audits and inspections\nBasic Qualifications \u2022 Degree qualified in an IS related discipline or equivalent\n\u2022 Substantial relevant knowledge and experience gained in an IS environment\nPreferred Qualifications Knowledge:\n\u2022 Intimate knowledge and experience of Drug Safety systems and supporting business processes\n\u2022 Experience of analysing business requirements related to E2B and Reporting Rules\n\u2022 Data interfaces/file transfer, reporting and analysis skills\n\u2022 Documentation management\n\u2022 Knowledge of Unified Modeling Language\n\u2022 Network, infrastructure, operating system & web technology fundamentals\n\u2022 Software development lifecycle\n\u2022 Database & SQL fundamentals\n\u2022 Technical diagram/process flow charting\n\u2022 Entity relationships, use cases, design and concepts\n\u2022 Change control techniques\n\u2022 MS Office & MS Project fundamentals", "date_new": "2012-02-24 19:33:07", "url": "http://www.amgen.jobs/xml/26739982/job", "country": "United Kingdom", "company": "Amgen", "title": "Sr Associate IS Bus Sys Analyst", "reqid": "13694BR", "state": null, "state_short": null, "location": "Cambridge, GBR", "uid": 26739982}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13086BR\nJob Posting Title Sr Scientist - Cell Sciences & Technology\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Cell Science and Technology department is recruiting a Senior Scientist level researcher within the cell line development and engineering functional area. The successful candidate will become a key member of a team focused upon the development of production cell lines for Amgen's large molecule biotherapeutic pipeline.\n\nThe successful candidate will help direct lab personnel in both cell line and technology development programs. This team member will work towards the continued development of new, cutting-edge technologies to enhance outcomes and improve current scientific understanding, directed towards improving production cell line development and performance; with yield, speed, and efficiency in mind.\n\nThe Senior Scientist will enhance and improve established platform approaches and utilize solid problem solving skills as well as out-of-the-box thinking to deliver technology improvements.\nBasic Qualifications - Doctorate degree & 2 years of scientific experience\nOR\n- Master\u2019s degree & 8 years of scientific experience\nOR\n- Bachelor\u2019s degree & 10 years of scientific experience\nPreferred Qualifications Candidates will require a solid scientific understanding of cell line development and associated technologies. Candidates will require strong mentoring capabilities, data driven decision-making and project management skills to help drive the team towards new performance levels.\n\nIt is highly desirable that candidates with demonstrated independence, innovation, some previous bioprocess experience and a strong track record apply for this position.\n\nTo be successful in this role, candidates should possess:\n- Ph.D. in molecular / cell biology or associated life science, combined with a minimum of 3+ years postdoctoral experience in a bioprocess development role or similar environment.\n- Strong molecular biology skills are essential together with expertise in mammalian cell culture, in particular stable cell line generation and clone screening.\n- Expertise in transcriptomics or similar \u2018omics\u2019 technologies and/or current gene knockout technologies highly advantageous.\n- Proven interdisciplinary project management skills\n- Ability to effectively mentor, motivate and manage more junior staff - previous FTE management experience essential\n- A track record in resolving and overcoming issues associated with the cell line development process and associated technologies\n- Recognized in the scientific community through a sustained record of publications and/or patents\n- Previous experience in the biotechnology/pharmaceutical required.", "date_new": "2012-02-24 04:09:09", "url": "http://www.amgen.jobs/xml/26721437/job", "country": "United States", "company": "Amgen", "title": "Sr Scientist - Cell Sciences & Technology", "reqid": "13086BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26721437}, {"country_short": "USA", "city": "Washington D.C.", "description": "Auto req 14015BR\nJob Posting Title Reimbursement Exec Dir\nCareer Category Government Affairs\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - District of Columbia\nLocation (City) Washington D.C.\nAmgen Job Description \u2022The Executive Director, Medical Policy will serve as the lead on clinical matters in Amgen\u2019s DC office and represent the function and company on clinical issues dealing with Federal (US) payers.\n\u2022The Executive Director, Medical Policy will also work collaboratively with the US Health Policy & Reimbursement BU Leads, Global Health Economics, and the Global Government Affairs team to support the company\u2019s Federal (US) coverage and reimbursement objectives.\n\u2022The Executive Director, Medical Policy will work collaboratively across functions to ensure a comprehensive view of the business, policy, and health economics issues and create and maintain strong collaborative working relationships with key stakeholders. These stakeholders include colleagues in other Global Value & Access functions (including Global Health Economics), Global Government Affairs, the Business Units, and marketing, development, law, regulatory, and operations groups.\n\u2022The Executive Director, Medical Policy will oversee and conduct relevant research and integrate clinical, market, and payer information to engage on coverage reimbursement objectives.\n\u2022The Executive Director, Medical Policy reports to the Executive Director, U.S. Health Policy & Reimbursement. The position is based in the Washington, DC office.\nBasic Qualifications -Completed medical degree (M.D. or equivalent)\n-10 or more years of relevant professional experience (8 or more years of related professional experience for candidates with an additional Master, JD, PhD degree/equivalent in a relevant field of study, such as health policy, business, or similar discipline)\n-At least 8 years biotechnology/pharmaceutical industry reimbursement experience and/or government / commercial payer experience\nPreferred Qualifications \u2022Strong understanding of Federal (US) payer environment, including areas of (1) approval, coverage, and reimbursement for both physician-administered and self-administered therapies and (2) health policy\n\u2022Detailed understanding of Federal (US) Executive and Legislative branch health care policy and payment rate-setting authorities, processes, and responsible parties\n\u2022Detailed understanding of Medicare and Medicaid statutes, regulations, and sub-regulatory policies related to coverage and reimbursement of health care products and services\n\u2022In-depth experience in dealing with government payer programs and interacting with government program decision-makers\n\u2022Ability to formulate health policy strategies that improve patient access to innovative therapies and implement these strategies to shape the external policy environment\n\u2022Ability to review and summarize detailed clinical literature, including disease state information and target product profiles, in order to (1) understand and explain implications for payer actions and to (2) develop submissions for payer engagement\n\u2022Strong project management skills with ability to work in a matrix environment\n\u2022Excellent communication skills, including interpersonal skills to foster collaboration and oral/written presentation skills\n\u2022Demonstrated success as a team leader\n\u2022Direct government or payer experience and/or experience in product commercialization desirable\n\u2022Previous experience in one of Amgen\u2019s therapeutic areas of focus preferred", "date_new": "2012-02-24 04:08:44", "url": "http://www.amgen.jobs/xml/26721425/job", "country": "United States", "company": "Amgen", "title": "Reimbursement Exec Dir", "reqid": "14015BR", "state": "District Of Columbia", "state_short": "DC", "location": "Washington D.C., DC", "uid": 26721425}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14014BR\nJob Posting Title Principal Scientist - Comparative Biology & Safety Sciences\nCareer Category Preclinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen is seeking an experienced scientist to actively contribute in the drug development process from target selection and lead optimization through product registration. Working in a collaborative team environment with other colleagues in Research and Translational Sciences (e.g. therapeutic area scientists, drug metabolism, chemistry, protein sciences, early clinical development), the incumbent will contribute to the selection and safety assessment of small molecule and biologic therapeutics and represent Comparative Biology & Safety Sciences (CBSS) on drug development teams within Amgen.\nAs a Principal Scientist in CBSS, you will design, implement, analyze and integrate a wide range of datasets from investigative studies and nonclinical safety assessment programs in support of drug development. Experience in resolving nonclinical safety issues through the establishment of novel protocols to solve experimental questions, in addition to devising strategies and planning activities to achieve project goals is required. An understanding of cutting-edge science and technology employed to enhance investigation of drug development safety liabilities is needed. You will participate and contribute to key project teams and provide regular updates as appropriate to senior management.\nBasic Qualifications Doctorate degree & 5 years of scientific experience\nOR\nMaster\u2019s degree & 12 years of scientific experience\nOR\nBachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications A D.V.M., M.D. and/or a Ph.D in a biological science with expertise in a specific disease discipline, comparative medicine or pathology.\nA minimum of 5 years of industry or academic experience demonstrating a sustained record of achievement.\nExperience is needed to critically evaluate and interpret integrated sets of data from scientific experiments and then translate the potential clinical impact.\nExcellent verbal and written communication skills are necessary.\nAdditional abilities expected include managing conflict, prioritization skills, resilience, and the demonstration of leadership through proactivity and influence, especially in a team environment.\nPost-doctoral research experience in toxicology, pathology or a disease specialty area.\nBoard certification in toxicology or pathology.\nThe preferred candidate will also have a working knowledge of computational and database tools for assessing multi-dimensional data and an ability to effectively query the literature and other public domain data repositories.\nThe ability to work independently and to build productive cross-functional collaborations both internally and externally is also preferred.", "date_new": "2012-02-22 20:28:59", "url": "http://www.amgen.jobs/xml/26687824/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - Comparative Biology & Safety Sciences", "reqid": "14014BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26687824}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14010BR\nJob Posting Title Post Doctoral Fellow - Protein Mass Spectrometry\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen Process & Product Development is seeking a postdoctoral fellow for developing and applying hydrogen/deuterium exchange (HDX) related technologies for protein product development. The duration of the fellowship is 2-3 years, with at least two years of commitment.\n\nThe successful candidate will work with a cross-site team to develop mass spectrometry (MS)-based HDX methodologies for routine use, and apply these methodologies for product-development issues such as protein folding and aggregation.\n\nPrimary responsibilities for this position include a) developing a robust and user-friendly LC/MS-based HDX platform for collecting and analyzing HDX-MS data; b) applying the platform for product development related issues such as conformation stability of different protein isomers, mechanism of protein aggregation, etc.; c) transferring the developed technologies to other Amgen labs; and d) exploring other HDX technologies such as FTIR, particularly data analysis tools. The project will include a collaboration effort and require travel to the other Amgen site in Seattle, WA. The candidate will write scientific articles about the developed technologies and their applications, as well as any significant discoveries from these technologies. The candidate should be experienced in protein mass spectrometry, and have excellent writing and communication skills.\nBasic Qualifications This position requires a PhD and experience in protein mass spectrometry. PhD must be awarded before the start of the post doctoral position.\nPreferred Qualifications Experience in MS-based HDX is preferred, and experience with protein FTIR or NMR is a plus.", "date_new": "2012-02-22 20:27:33", "url": "http://www.amgen.jobs/xml/26687723/job", "country": "United States", "company": "Amgen", "title": "Post Doctoral Fellow - Protein Mass Spectrometry", "reqid": "14010BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26687723}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13787BR\nJob Posting Title Sr Associate Scientist\nCareer Category Process Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Seeking a highly motivated individual to function as a member of a commercial (drug product) process development team, focused on providing support to technology transfers, process characterization and commercial manufacturing. Position will perform experiments, organize data and analyze results with minimal supervision. Evaluation of product impact due to process variables will be a critical deliverables for this role. Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods is a need for this role. The position will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, and communicate data to the cross functional group. Experience with root cause analysis and technical investigations in the fill/finish area is a plus. Cross functional teamwork will be a critical component of this job. Regular interactions with Quality and Regulatory functions are expectations for this role. Effective communication skill is a requirement with the ability to exert influence a plus for this role.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Sciences or related field.\n\u2022 2+ years experience within the pharmaceutical/biotechnology industry; Experience to include understanding of physical / chemical stability of proteins, and interpreting results from various analytical methods on proteins. Process characterization, scale-up, and/or technology transfer experience.\n\u2022 Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality.\n\u2022 Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing.", "date_new": "2012-02-17 19:41:02", "url": "http://www.amgen.jobs/xml/26597058/job", "country": "United States", "company": "Amgen", "title": "Sr Associate Scientist", "reqid": "13787BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26597058}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13954BR\nJob Posting Title Scientist\nCareer Category Research\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.\n\nAs an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.\n\nWe are currently seeking a Scientist for our Clinical Immunology group.\n\nThis role will:\n\n\u2022 Design and execute specific scientific experiments for development, validation and implementation of methods capable of detecting anti-drug neutralizing antibodies or for measurement of drug biological activity in clinical and nonclinical study samples\n\n\u2022 Develop and implement new and novel protocols to address specific issues and/or troubleshoot and improve currently existing assays towards being more sensitive, transferable, and high-throughput\n\n\u2022 Conduct data analysis and interpretation, and assesses impact of the data on the project\n\n\u2022 Provide technical support and expertise to department operating groups when needed\n\n\u2022 Represent the department on cross-functional project teams\n\n\u2022 Provide scientific oversight to transfer of assays to CROs\n\n\u2022 Assist senior-level Scientists in managing clinical and/or non-clinical programs\n\n\u2022 Contribute as lead author on scientific documents such as journal publications, technical reports, etc.\nBasic Qualifications Doctorate degree\n\nOR\n\nMaster\u2019s degree & 3 years of directly related experience\n\nOR\n\nBachelor\u2019s degree & 5 years of directly related experience\nPreferred Qualifications A successful candidate in this role should:\n\n\u2022 Post doc experience preferred\n\n\u2022 Demonstrate innovation in cell signaling, in vitro assay design\n\n\u2022 Be able to solve complex problems demonstrating a deep understanding in a scientific area of expertise.\n\n\u2022 Demonstrate ability to drive scientific excellence and innovation.\n\n\u2022 Knowledge of the drug development process\n\n\u2022 Have the ability to effectively present scientific information both internally and externally to influence decisions and/or scientific practices\n\n\u2022 Demonstrate knowledge of the IND/NDA process\n\n\u2022 General knowledge of the field of Immunology, Oncology, Immunochemistry, or Cell Biology and pertinent immunologic assays.\n\n\u2022 Experience in in vitro cell-based assays and related technologies, in-depth knowledge of signal transduction processes.\n\n\u2022 Development, validation, transfer and implementation of assays detecting and characterizing antibodies to protein products in biological matrices and/or measuring drug activity.\n\n\u2022 Development, validation, transfer and implementation of fluorescence-based assays in cell lines, animal model and/or human specimens in collaboration with analysts and scientists in a variety of clinical / therapeutic areas.\n\n\u2022 Project Management as it pertains to oversight of vendors, assay transfers and implementation of outsourced assays.\n\n\u2022 Ability to communicate complex ideas to audiences with varying degrees of knowledge\n\n\u2022 Initiative\n\n\u2022 Attention to detail\n\n\u2022 Independence of thought demonstrated through hypothesis formulation, experimental design, interpretation and innovation\n\n\u2022 Demonstrated critical thinking with an ability to integrate data and information to solve complex problems\n\n\u2022 Ability to collaborate on a functional and/or cross-functional team as a leader and/or a member\n\n\u2022 Ability to build and manage a team", "date_new": "2012-02-17 19:39:09", "url": "http://www.amgen.jobs/xml/26597026/job", "country": "United States", "company": "Amgen", "title": "Scientist", "reqid": "13954BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26597026}, {"country_short": "ESP", "city": "Barcelona", "description": "Auto req 13951BR\nJob Posting Title Value & Access Director\nCareer Category Government Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) Spain\nLocation (City) Barcelona\nAmgen Job Description The candidate will be located in the affiliate of Amgen Spain (Barcelona), and reports to General Manager with dotted line to the Regional Access Head EU & AUZ. He/She will be a member of the Country Management Team.\nThe candidate must oversee and coordinate the development and implementation of strategies to secure/maintain access at optimal prices for all Amgen in-market and launching products within the affiliate.\n\nMain Responsibilities:\n\u2022 Lead V&A team within the affiliate; sets direction for access planning and implementation, fosters collaboration with cross-functional partners, and mentors/supervises direct reports\n\u2022 Ensure close partnership with Governmental Affairs (GA) to develop optimal approach with governmental (both national and regional payers)\n\u2022 Achieve ACCESS: Anticipate together with GA environmental and policy changes; Collaborate proactively with payers and HTAs; Consider pricing strategies and creative alternatives; Evidence to demonstrate value; Shape together with GA the policy environment; Strategy development and flawless execution to ensure access goals are achieved\n\u2022 Anticipate the changing payer and policy landscape by closely monitoring national and regional pricing and HTA actions\n\u2022 In partnership with Affiliate GA proactively engage and collaborate with payers in strategic relationships. If appropriate, and in collaboration with the Regional Access team, engage with payers and HTAs in discussions of our pipeline evidence generation plans to gain feedback and to foster collaborative relationships\n\u2022 Engage with ICO Pricing and Contracting team to develop and implement local price policies and consider creative pricing strategies (e.g., risk-sharing; or conditional coverage schemes) if needed to secure access\n\u2022 Engage with Regional IHE team to generate the right value evidence\u2014as expected by national and regional authorities\u2014to effectively address threats to in-line molecules and demonstrate value of our pipeline products. Ensure that local HE team proactively partners with international and global HE function on critical value proposition elements (evidence, models, HTA submissions, training, etc.)\n\u2022 Shape the environment, in partnership with GA, by effectively engaging with key stakeholders (e.g., payers, policy makers, economic KOLs)\n\u2022 Partner with Regional team to drive development and implementation of affiliate access strategy across the portfolio\no Integrate pricing and contracting, reimbursement and payer planning, health economics, and HTA and payment policy\no Integrate product strategy, complementary added vale services and value proposition with affiliate price and reimbursement mechanisms to determine optimal access strategy with contingency plans into strategic plan\no Articulate strategy and tactical plans into comprehensive plan for each product\no Build realistic access and pricing assumptions into forecast\no Leverage all available resources (e.g., clinical, regulatory, commercial, health economic, etc.) to develop and implement tactical plans and identify and overcome access barriers\no Execute strategy and monitor progress to determine need for changes in strategy\n\u2022 Partner with Affiliate GA Head to define negotiation strategy and develop political stakeholder and government agency engagement plan depending on needs\n\u2022 Engage with Regional IHE Head and/or regional IHE Product Leads to ensure that affiliate needs for pipeline programs are appropriately incorporated and prioritized in planning international and global programs\nBasic Qualifications \u2022 University Degree and a complimentary MBA education will be a plus\n\u2022 At least 2 or 3 years of experience in a similar position and at least\n\u2022 Strong understanding of affiliate payer environment, including coverage and reimbursement, pricing and contracting, value drivers, formulary management, health technology assessment, HTA and payment policy\n\u2022 Demonstrated experience in access strategy development and implementation\nPreferred Qualifications \u2022 Accomplished team and business leader\n\u2022 Experience with direct payer engagement preferred, including established relationships with local decision makers and influencers. Concrete examples on implementing successful value proposition to payers will be valued.\n\u2022 Strong understanding of strategic pricing and contracting, including innovative approaches such as risk-sharing deals\n\u2022 Understanding of health policy preferred\n\u2022 Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies in order to understand implications for value to payers", "date_new": "2012-02-16 22:00:31", "url": "http://www.amgen.jobs/xml/26576316/job", "country": "Spain", "company": "Amgen", "title": "Value & Access Director", "reqid": "13951BR", "state": null, "state_short": null, "location": "Barcelona, ESP", "uid": 26576316}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 13960BR\nJob Posting Title Specialist QA\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nAmgen Job Description Objectives\nProvides the QA oversight review and approval of validation strategies and documents\nProvides QA oversight review and approval of Packaging Engineering strategies and documents\n\nPosition Specific Tasks\n\nOperational\n- Provide guidance for validation impact assessment for change control requests.\nParticipate in ABR projects and improvement efforts.\n- Ensures that Quality policies, procedures and programs are properly implemented in daily Process Development operations and remain in compliance\n- Provide coaching, guidance and compliance direction to Facilities, Engineering , Maintenance and Process Development.\n- Work with other disciplines in developing requirements and strategies for large and/or highly complex process, system and facility modifications.\n- Develop solutions to complex validation problems requiring the use of ingenuity and creativity while maintaining compliant.\n- Work with project managers to complete the validation responsibilities of projects within schedule, budget and quality constraints.\n- Provide Quality oversight and approval for process development, engineering, validation projects and validation deliverables\n- Provide Quality oversight for good engineering practice documentation and system development.\n\nProcess Maintenance:\n- Ensure Validation process at the site is maintained according to Corporate and GMP requirements and procedures reflecting process are in place and effective.\n- Integrate advanced validation engineering techniques ensuring alignment with industry standards.\n- Develop and provide Validation Training\n- Act as Validation contact in corporate and regulatory inspections, as needed.\nBasic Qualifications Minimum Requirements\n- Bachelor\u2019s degree in Life Sciences or Engineering field or equivalent.\n- Typically 5+ years of related professional experience.\nOR\n- Master\u2019s degree in Life Sciences or Engineering field or equivalent.\n- Typically 3+ years of related professional experience.\nOR\n- PhD in Life Sciences or Engineering field or equivalent.\n- Typically 1+ years of related professional experience.\n\n- Fluent in English.\n- Direct experience with regulated environment required.\n- Strong knowledge of GAMP, ASTM E2500, Annex 13, ICH Q7A, CFR 11, 210 and 211.\nPreferred Qualifications Preferred Requirements\n- Typically 10+ years of related industry experience in anufacturing and/or Quality Assurance. Strong knowledge of Good Distribution Practices.", "date_new": "2012-02-16 21:59:39", "url": "http://www.amgen.jobs/xml/26576301/job", "country": "Netherlands", "company": "Amgen", "title": "Specialist QA", "reqid": "13960BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 26576301}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13873BR\nJob Posting Title Manufacturing Specialist - NPI/Packaging\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role will work within the New Product Introduction group of Amgen\u2019s ATO Fill and Packing Organization and will be a key process leader in the introduction of new products within the Packaging department.\n\nThe specialist will be a representative for ATO Packaging within the clinical commercialization program and serve as a key manufacturing operations liaison for new product introductions with an high degree of expected interaction with Quality, Planning, Engineering, Clinical Planning, Process Development, Global Operations teams, and other supportive and client groups.\n\nAdditional responsibilities will include routine interaction with key quality and manufacturing systems, as well as with Operational Excellence (OE) initiatives, and global networks.\n\nAreas of scope and responsibilities include but are not limited to:\n\n\u2022 Supporting/Leading New Product Introductions (NPIs)\n\u2022 Ability to write, revise, and own manufacturing documentation (SOPs, Manufacturing Procedures, Device requirements (MPs), Forms)\n\u2022 Owner/lead author for Non-Conformances (NC\u2019s), Corrective and Preventive Actions (CAPA\u2019s), and Change Controls records that occur in association with the new product introduction process.\n\u2022 Work closely with Regulatory, Quality, and required accessors to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the new product introductions\n\u2022 Operational Excellence (OE) core team member who will champion OE initiatives, and facilitate the drive towards continuous improvement as it relates to new product introductions processes and shared opportunities with client and support groups\n\u2022 Work closely with Quality, Engineering, Process Development, Validation, and Operations to resolve project management issues in a timely manner\n\u2022 Assure appropriate escalation to various levels of management when timeline requirements for new product introduction are at risk or exceeded\n\u2022 Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams\n\u2022 Apply advanced process, operational, scientific expertise, compliance knowledge and analytical and troubleshooting skills to support manufacturing operations\n\u2022 Manage generation and presentation of key operating metrics for functional area\n\u2022 Provide training to manufacturing staff in support of new product introduction where appropriate\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor\u2019s degree & 5 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)\n\u2022 Project management experience\n\u2022 Detailed technical understanding of packaging operations\n\u2022 Experience participating in and leading cross-functional teams\n\u2022 Experience in managing multiple, competing priorities in a fast-paced environment\n\u2022 Strong technical writing and verbal presentation skills\n\u2022 Ability to be flexible and manage change\n\u2022 Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms\n\u2022 Ability to communicate/manage upwards to high level stake holders (Director and above)\n\u2022 Highly detailed orientated\n\u2022 Exceptional organizational skill\n\u2022 Experience with a Current Good Manufacturing Practices (cGMP)\n\u2022 Experience with change control and non-conformance management systems/processes\nPreferred Qualifications:\n\u2022 Extensive technical knowledge of drug product packaging, drug product delivery devices, and a broad understanding of related disciplinary areas\n\u2022 Experience interacting with representatives of regulatory agencies\n\u2022 Detailed technical understanding of packaging operations\n\u2022 Strong experience with Microsoft Office suite - PowerPoint, Word, Outlook\n\u2022 Advanced Microsoft Excel experience in the management/analysis of data; including use of Excel Pivot Tables and advanced Excel chart management (formula statements, etc)\n\u2022 Strong experience with Microsoft SharePoint environment including the creation and management of Ninetex workflow\n\u2022 Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.\n\u2022 Understands the core functional business processes and their role in Amgen's commercialization program", "date_new": "2012-02-16 21:59:19", "url": "http://www.amgen.jobs/xml/26576291/job", "country": "United States", "company": "Amgen", "title": "Manufacturing Specialist - NPI/Packaging", "reqid": "13873BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26576291}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13564BR\nJob Posting Title Clinical Research Medical Director - Hematology / Oncology\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Clinical Research Medical Director will work within the Hematology/Oncology Therapeutic Area.\n\nThe responsibilities for this role include:\n\n- Supporting the development, execution and communication of the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Supporting the development of key scientific external relationships with opinion leaders\n- Participating and providing clinical input into safety and regulatory interactions\n\n\nKey Activities:\n\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Interpret clinical trial data\n- Participate in safety assessments\n- Participate in interactions with regulatory agencies\n- Author CSRs, publications and regulatory submissions\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL\n- Identify new clinical research opportunities\n- Support in-licensing and out-licensing activities and partner relationships\n- Support product lifecycle management for new indications as directed by Global Development Leader\n- Provide clinical content input to:\n- Regulatory interactions and documents\n- Safety interactions and documents\n- Materials to be used in Scientific Affairs\n- Materials to be used by the Commercial Organization\nBasic Qualifications - MD\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\nPreferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent\n- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\n- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n- Experience in clinical research in hematology and/or oncology", "date_new": "2012-02-16 21:58:36", "url": "http://www.amgen.jobs/xml/26576276/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Director - Hematology / Oncology", "reqid": "13564BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26576276}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13963BR\nJob Posting Title Principal Scientist\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This is an exciting opportunity in the Early Development/ Molecular Sciences group at Amgen that could be situated in either the Seattle, WA or Thousand Oaks, CA campus for an individual to explore and apply pharmacodynamic and patient stratification biomarkers in the context of informing the decision-making process in drug development for cardiovascular therapeutics. The successful candidate will be responsible for leading and coordinating the biomarker effort for a portfolio of concurrent research and clinical projects. This responsibility would extend from efforts discovering and evaluating candidate biomarkers to overseeing the execution of biomarker assessments in clinical trials. The candidate will drive the implementation of biomarker strategy in clinical studies through close collaboration with discovery research, preclinical and early clinical development teams in the metabolism and general medicine areas. The candidate will also be responsible for organizing and contributing to the cross-functional and cross-site team interaction including meetings, reports and presentations.\nBasic Qualifications \u2022 Doctorate degree & 5 years of scientific experience\nOR\n\u2022 Master\u2019s degree & 12 years of scientific experience\nOR\n\u2022 Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications \u2022Ph.D in life sciences and 2+ years of post-doctoral experience and 4+ years of industry experience.\n\u2022Experience in the discovery and implementation of biomarkers within clinical studies for cardiovascular disease (e.g. lipid regulation, dyslipidemia, atherosclerosis).\n\u2022Strong desire to be part of the flexible and dynamic environment of early development, and be capable of supporting a broad portfolio of novel projects.\n\u2022A strong background in cardiovascular biology, with emphasis on the understanding of pathway interventions applied as therapeutics.\n\u2022Strong skills in critical thinking, laboratory experimentation and analysis, and understanding of the advantages and limitations of exploratory analyses in the clinical setting.\n\u2022Effective communication and interpersonal skills and the ability to work in a matrix environment are essential.", "date_new": "2012-02-15 22:00:25", "url": "http://www.amgen.jobs/xml/26547305/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist", "reqid": "13963BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26547305}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13910BR\nJob Posting Title Medical Sciences Medical Dir - Oncology\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Medical Sciences Group is looking for a strong leader in Hematology/Oncology.\n\nThe Medical Sciences leaders identify, organize, and execute early phase clinical and translational projects and substantially contribute to drug development. Throughout this continuum, they identify and manage external collaborators and consultants in completion of key projects. These experts represent Medical Sciences internally and externally, contributing intellectual insight into experimental design and data analysis. They typically serve as project leaders for at least one of Amgen\u2019s Product Strategy Teams through their role as an Early Development Leader (EDL).\n\nThis person filling this position must have demonstrated expertise in conducting translational and/or clinical oncology research, and will be the primary Medical Sciences contact for basic scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing later clinical development.\n\nIn addition, the candidate will have the following responsibilities:\n\nServe as an internal clinical expert in translational and clinical oncology.\n\nServe as medical monitor for clinical trials and assists in resolving major issues that may affect the studies.\n\nPresent information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.\n\nCoordinate clinical approaches to operational issues and assign monitoring and safety reporting resources.\n\nProvide guidance and assistance in the identification and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.\n\nEnsure appropriate training, recruitment, and development requirements for matrix team resources.\nBasic Qualifications \u2022MD\n\u2022Two(2)or more years of clinical research and/or basic science research experience\nPreferred Qualifications \u2022MD plus accredited residency in Oncology and/or Malignant Hematology, board certified\n\u2022MD/PhD and a strong basic science or clinical research background in academics or pharma\n\u2022Effective presentation and communication abilities (both written and oral)\n\u2022Ability to anticipate problems and find creative solutions\n\u2022In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n\u2022A record of high quality peer-reviewed publications\n\u2022Experience functioning as a medical expert in a complex matrixed environment\n\u2022Previous experience in early phase development and/or biomarker work is a strong plus", "date_new": "2012-02-15 21:59:43", "url": "http://www.amgen.jobs/xml/26547283/job", "country": "United States", "company": "Amgen", "title": "Medical Sciences Medical Dir - Oncology", "reqid": "13910BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26547283}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13888BR\nJob Posting Title Medical Sciences Medical Dir\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The candidate must be able to identify and organize preclinical and clinical scientific data in order to execute on early clinical studies that substantially contribute to early product development. Serve as a leader within Early Development (ED), with an interest and growing capability in representing the department on internal groups, such the ED protocol review committee. Identify and maintain relationships with key external collaborators. Contribute critical intellectual insights to strategy for generating decision-making, early clinical trial data. Collaborate in a team atmosphere, on interpretation and reporting of early clinical trial data. Responsible for responding to queries from regulatory agencies and participate in negotiations with these groups. The successful candidate will have the opportunity to lead late stage pre-clinical/early clinical Product Strategy Teams (PST) for Amgen\u2019s early development pipeline.\nBasic Qualifications \u2022 MD\n\u2022 3 years clinical trial experience in industry and/or academic setting\nPreferred Qualifications \u2022 Residency in Internal Medicine or related discipline\n\u2022 Subspecialty fellowship training in Clinical Pharmacology, or an Internal Medicine subspecialty, with a background in translational medicine\n\u2022 Experience interacting with or serving on an IRBs or Ethics Committees\n\u2022 Board certification or eligible\n\u2022 M.D./Ph.D. in biological science\n\u2022 Excellent oral and written communication skills\n\u2022 Excellent interpersonal skills\n\u2022 Experience in early clinical trials\n\u2022 Solid understanding of GCP and Healthcare Compliance\n\u2022 Experience in basic research and clinical trial methodology\n\u2022 Publication track record\n\u2022 Ability to lead, manage and motivate teams", "date_new": "2012-02-14 20:00:48", "url": "http://www.amgen.jobs/xml/26520634/job", "country": "United States", "company": "Amgen", "title": "Medical Sciences Medical Dir", "reqid": "13888BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26520634}, {"country_short": "DEU", "city": "Munich", "description": "Auto req 13952BR\nJob Posting Title Health Economics Senior Manager\nCareer Category Health Economics\nEmployee Subgroup Salaried FT\nCountry (State/Region) Germany\nLocation (City) Munich\nAmgen Job Description Insbesondere gegen\u00fcber gesundheitspolitischen Entscheidungstr\u00e4gern spielen Sie eine bedeutende Rolle hinsichtlich der Vermarktung und Positionierung unserer Produkte und gew\u00e4hrleisten in Zusammenarbeit mit dem Value & Access- sowie unserem Medical-Team die kompetente und umsichtige Ausarbeitung unserer produktspezifischen Value Dossiers. Mit den nachfolgenden Verantwortlichkeiten unterst\u00fctzen Sie ma\u00dfgeblich die Erstattung unserer Produkte und deren Zugang zum Markt:\n\n- Eigenverantwortliche Erstellung von AMNOG-Dossiers/ Health Technology Assessments (HTA) in Anlehnung an unsere Global Value Dossiers sowie deren Einbindung in die lokalen Business Strategien in Anlehnung an die europ\u00e4ische Strategie\n- Entwicklung und lokale Adaptation der produktspezifischen \u201eValue Proposition\n- Design und Durchf\u00fchrung von Beobachtungsstudien und Datenbankanalysen im Rahmen profunder Versorgungsforschungsprojekte, auch in Zusammenarbeit mit Kostentr\u00e4gern\n- Entwicklung und Implementierung lokaler Health Economics-/HTA Kommunikations- und Publikationsstrategien in Anlehnung an unsere europ\u00e4ischen Pl\u00e4ne\n- Aktive Teilnahme an lokalen HEOR/HTA Workshops und Symposien mit Fach- und Wirtschaftsgremien sowie Aussch\u00fcssen im gesundheitspolitischen Bereich (Kooperation mit IQWiG)\n- Darstellung des wirtschaftlichen und klinischen Nutzens unserer Produkte bei den Entscheidungstr\u00e4gern\n- Ausbau des Meinungsbildner-Netzwerkes im gesundheitspolitischen Umfeld\n- Lokale Adaptation gesundheits\u00f6konomischer Modellierungen\n- Aktive Zusammenarbeit mit den europ\u00e4ischen Health Economics Kollegen und Arbeitsgruppen\n- Ansprechpartner f\u00fcr die Produktteams f\u00fcr alle Fragen bez\u00fcglich Health Economics, \u201eValue Propositions und Erstattungsfragen\n- Erstellung und Durchf\u00fchrung interner Trainingsprogramme f\u00fcr den Bereich Gesundheits\u00f6konomie\nBasic Qualifications - Abgeschlossenes Studium, idealerweise in Gesundheits\u00f6konomie oder Medizin/Naturwissenschaften mit nachgewiesener profunder Zusatzqualifikation in Gesundheits\u00f6konomie\n- Mehrj\u00e4hrige Berufserfahrung in der Pharmaindustrie, innerhalb des Krankenversicherungswesens oder gesundheits\u00f6konomischen Beratungsfirmen\n- Fundierte Kenntnisse der Methodik gesundheits\u00f6konomischer Modellierung, Design und Implementierung von Kosten-Effektivit\u00e4tsstudien sowie von Krankheitskostenstudien\n- Kenntnisse und idealerweise Erfahrung in den Methoden der Erstellung systematischer Literaturreviews\n- Fundierte Kenntnisse der Methoden der Versorgungsforschung\n- Fundierte Kenntnisse der lokalen Erstattungsrichtlinien im Gesundheitswesen\n- Erfahrung in der Onkologie wie auch in der Nephrologie w\u00e4ren von Vorteil\n- Analytisches Denken, sicheres Einsch\u00e4tzungsverm\u00f6gen des wirtschaftlichen und gesundheitspolitischen Gesch\u00e4ftsumfeldes und ein Gesp\u00fcr f\u00fcr daraus resultierende Entwicklungen und Marktchancen\n- Sehr gutes und sicheres Auftreten, Kommunikations- und Pr\u00e4sentationsf\u00e4higkeiten sowie Verhandlungsgeschick und Entscheidungsfreude, \u00dcberzeugungsf\u00e4higkeit und Ergebnisorientierung\n- Sehr gute Englischkenntnisse in Wort und Schrift\n- Sicherer Umgang mit MS-Office, insbes. Excel, Kenntnisse in Modellierungssoftware (z.B. TreeAge) sind von Vorteil\n- Reisebereitschaft\nPreferred Qualifications Was wir Ihnen bieten:\n\n- Die M\u00f6glichkeit, Ihre Karriere bei einem der innovativsten und erfolgreichsten Unternehmen der Branche zu gestalten\n- Die Entwicklung Ihrer fachlich-professionellen F\u00e4higkeiten sowie Ihrer pers\u00f6nlichen und sozialen Kompetenzen\n- Ein durch Offenheit und Erfolgsorientierung gepr\u00e4gtes Arbeitsumfeld\n- Attraktive Vertragsbedingungen und Sozialleistungen\n\nM\u00f6chten Sie sich bewerben? Dann laden wir Sie als zukunftsweisendes, innovatives Unternehmen herzlich auf unser Karriere-Portal unter www.amgen.de ein. Wir bitten Sie, sich dort entsprechend zu registrieren und uns Ihre Bewerbung (auf o.g. Requisiton-Nr. 13952BR) online zu \u00fcbermitteln. Selbstverst\u00e4ndlich bewahren wir alle datenschutzrechtlichen Bestimmungen.\n\nF\u00fcr Fragen vorab steht Ihnen Frau Martina Rech (Staffing Manager) gerne unter der Telefonnummer (089) 14 90 96-1112 zur Verf\u00fcgung.", "date_new": "2012-02-14 19:52:24", "url": "http://www.amgen.jobs/xml/26520420/job", "country": "Germany", "company": "Amgen", "title": "Health Economics Senior Manager", "reqid": "13952BR", "state": null, "state_short": null, "location": "Munich, DEU", "uid": 26520420}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13864BR\nJob Posting Title HVAC & Utilities Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Job Title HVAC/Utilities Validation Engineer\n\nJob Description HVAC/Utilities Validation Engineer\n\nAs a HVAC/Utilities validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the HVAC/Utilities for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.\n\nMajor Responsibilities\n\n\u2022 Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for HVAC and Utilities for a Sterile Fill Finish Facility.\n\u2022 Ensure all aspects of HVAC/Clean Utility Validation adhere to required policies and procedures, including safety and training.\n\u2022 Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.\n\u2022 Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.\n\u2022 Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for HVAC, Clean Steam, Process Air and WFI Systems.\n\u2022 Participate as required in project activities.\n\u2022 Review of Existing Site Systems to ensure compliance.\n\u2022 Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS\u2019s), Factory Acceptance Tests (Fat\u2019s) to ensure the QBD principles are being followed.\n\u2022 Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents\n\u2022 Collate and report on relevant Validation data/matrices.\n\u2022 Assist in deviation and exception resolution and root cause analysis.\n\u2022 Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.\n\u2022 Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.\nBasic Qualifications Experience/Background\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.\n\u2022 Minimum 4-6 years experience in a similar role.\n\n\nEducation Requirements\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.", "date_new": "2012-02-13 19:30:14", "url": "http://www.amgen.jobs/xml/26495641/job", "country": "Ireland", "company": "Amgen", "title": "HVAC & Utilities Validation Engineer", "reqid": "13864BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26495641}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13863BR\nJob Posting Title Sterile Filling & Inspection Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Job Title Sterile Filling and Inspection Validation Engineer\n\nJob Description Sterile Filling and Inspection Validation Engineer\n\nAs a Sterile Filling and Inspction validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Sterile Syringe Filling and Inspection for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.\n\nMajor Responsibilities\n\n\u2022 Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Sterile Syringe Filling, Isolator and Inspection for a Sterile Fill Finish Facility.\n\u2022 Ensure all aspects of Syringe Filling, Isolator and Inspection Validation adhere to required policies and procedures, including safety and training.\n\u2022 Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.\n\u2022 Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for Syringe Filling, Isolator and Inspection Systems.\n\u2022 Participate as required in project activities.\n\u2022 Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS\u2019s), Factory Acceptance Tests (Fat\u2019s) to ensure the QBD principles are being followed.\n\u2022 Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents\n\u2022 Collate and report on relevant Validation data/matrices.\n\u2022 Assist in deviation and exception resolution and root cause analysis.\n\u2022 Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.\nBasic Qualifications Experience/Background\n\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.\nSyringe Filling and Isolator Technology Experience essential\nAutomated Inspection Technology Experience an advantage\n\u2022 Minimum 4-6 years experience in a similar role.\n\n\nEducation Requirements\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.", "date_new": "2012-02-13 19:30:03", "url": "http://www.amgen.jobs/xml/26495637/job", "country": "Ireland", "company": "Amgen", "title": "Sterile Filling & Inspection Validation Engineer", "reqid": "13863BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26495637}, {"country_short": "IRL", "city": "Dublin", "description": "Auto req 13867BR\nJob Posting Title Sr Packaging Validation Engineer\nCareer Category Engineering\nEmployee Subgroup Salaried FT\nCountry (State/Region) Ireland\nLocation (City) Dublin\nDun Laoghaire\nAmgen Job Description Job Title Senior Packaging Validation Engineer\n\nJob Description Senior Packaging Validation Engineer\n\nAs a senior Packaging validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials are in compliance with Division Quality System requirements and recognised international standards.\n\nMajor Responsibilities\n\n\u2022 Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations.\n\u2022 Leading the team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training.\n\u2022 Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.\n\u2022 Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.\n\u2022 Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.\n\u2022 Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS\u2019s), Factory Acceptance Tests (Fat\u2019s) to ensure the QBD principles are being followed.\n\u2022 Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents\n\u2022 Collate and report on relevant Validation data/matrices.\n\u2022 Assist in deviation and exception resolution and root cause analysis.\n\u2022 Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.\n\u2022 Participate as required in project activities.\n\u2022 Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.\nBasic Qualifications Experience/Background\n\n\u2022 A third level qualification in Science, Engineering or a relevant Quality discipline.\n\u2022 Minimum 5-10 years experience in a similar role.\nPreferred Qualifications Overall knowledge in equipment, facility, cleaning and steaming validation. Technical understanding of pharmaceutical/biotechnology unit operations. Project management skills Skilled at initiation and leading cross functional teams Database and spreadsheet application skills Strong technical writing and oral communication skills Facilitation and presentation skills Experience with leading complex investigations and CAPAs Ability to evaluate compliance issues and interact with regulatory inspectors", "date_new": "2012-02-13 19:29:10", "url": "http://www.amgen.jobs/xml/26495601/job", "country": "Ireland", "company": "Amgen", "title": "Sr Packaging Validation Engineer", "reqid": "13867BR", "state": null, "state_short": null, "location": "Dublin, IRL", "uid": 26495601}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13841BR\nJob Posting Title Exec Dir Regulatory Affairs - Bone TA\nCareer Category Regulatory\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role leads the Bone Therapeutic Area team within Amgen's Regulatory Affairs department. The Therapeutic Area Head (TAH) manages a team responsible for developing and executing regulatory strategies and managing effective regulatory agency interactions to achieve desired regional labeling and global registration.\n\nThe TA Head will represent Global Regulatory Affairs as a member of the Therapeutic Area Steering Committee (TASC) within the Amgen Commercialization Process in addition to providing high-level strategic guidance to Global Regulatory Leaders.\n\nKey Activities:\n\u2022 Consult with Global Regulatory Leaders (GRL) in development of global regulatory strategies and approve Global Regulatory Plan and Global Strategic Plan\n\u2022 Global oversight of all regulatory aspects between and across products within a therapeutic area\n\u2022 In collaboration with Amgen regional staff, interact and negotiate with key regulatory agency officials in the execution of Global Strategic Plans\n\u2022 Oversee core regulatory and cross-functional teams to ensure effective agency interactions\n\u2022 Provide technical expertise in inspections, negotiate the need for inspections, review responses to observations\n\u2022 Provide input to TASC, senior management review committees, governance boards, other cross-functional product meetings\n\u2022 Provide guidance to team on regulatory strategies, precedence and risk management\n\u2022 Consult and review contingency planning/risk assessment for products within a therapeutic area development strategies and agency interactions\n\u2022 Monitor, assess and communicate impact of relevant global regulations, guidance\u2019s current regulatory environment and competitor labeling\n\u2022 Assist corporate training on regulatory affairs and contribute to the design and content development of department training programs\n\u2022 Provide coaching, mentoring, and development of staff\nBasic Qualifications \u2022 Doctorate degree and 6 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies\nOR\n\u2022 Master\u2019s degree and 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies\nOR\n\u2022 Bachelor\u2019s degree and 12 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies\nAND\n\u2022 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources\nPreferred Qualifications \u2022 Advanced degree\n\u2022 Regulatory submissions experience specific to bone products\n\u2022 Experience interacting with senior regulatory agency representatives\n\nKnowledge and Skills leveraged in the role:\n\u2022 Strong communication skills \u2013 both oral and written\n\u2022 Ability to understand and communicate scientific/clinical information\n\u2022 Demonstrated ability to lead teams", "date_new": "2012-02-11 19:45:48", "url": "http://www.amgen.jobs/xml/26476662/job", "country": "United States", "company": "Amgen", "title": "Exec Dir Regulatory Affairs - Bone TA", "reqid": "13841BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26476662}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13890BR\nJob Posting Title Principal Scientist - PKDM\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department. The Principal Scientist will serve as a PK/PD expert and Pharmacometrican to support Amgen Development and Discovery programs in the Oncology Therapeutic Area. The successful candidate will implement advanced modeling & simulation (M&S) strategy, develop M&S cutting edge methodology, and work collaboratively with cross-functional teams to optimize PK/PD study design and study protocol. He/she will be responsible for hands-on PK/PD analyses, modeling & simulations, report writing, and the preparation and maintenance of Investigator Brochures, IND/IMPD/CTX/RTQ/CTD, and other summary documents for regulatory submissions. He/she may transition into the role of PKDM Development Project Team Representative and independently represent the function area when appropriate. Development of junior members and interaction with the line-management will also be key responsibilities.\nBasic Qualifications \u2022Doctorate degree & 5 years of scientific experience\nOR\n\u2022Master\u2019s degree & 12 years of scientific experience\nOR\n\u2022Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications \u2022PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training\n\u2022Specialized in PK/PD modeling and population-based analyses/simulations with established track-record records of model-based drug development\n\u2022Experience in supporting preclinical/clinical PK, PK/PD, and modeling & simulation components of regulatory documentations.\n\u2022Leadership quality for effective team building with strong decision making and problem solving skills\n\u2022Excellent interpersonal, technical, and communication skills to lead cross-functional teams\n\u2022Candidate with R&D experience to support small and/or large molecule oncology therapeutics\n\u2022Demonstrated experience with modeling and simulation software (e.g. NONMEM, SAS, S-Plus, Pharsight Clinical Trial Simulator)\n\u2022Excellence and eminence in field of PK/PD and modeling & simulation with peer-review articles and external presentations.", "date_new": "2012-02-10 18:17:40", "url": "http://www.amgen.jobs/xml/26456588/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - PKDM", "reqid": "13890BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26456588}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 13823BR\nJob Posting Title Sr Engineer - Mfg Projects\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Colorado\nLocation (City) Boulder\nAmgen Job Description Amgen Colorado\u2019s Engineering team is responsible for delivering capital and expense improvement projects to our client\u2019s business needs. We target small to moderate sized projects located within operating business units. We feature staff with diverse engineering backgrounds with intimate knowledge of operations and working in GMP environments. We minimize impact to client operations due to excellent planning, coordination, and controls.\n\nThe Sr. Engineer is responsible for engineering design, implementation, construction support, technical execution and commissioning for multiple capital and expense projects at Amgen Colorado. This involves preparation of engineering studies, conceptual design alternatives, schematic and design details, and commissioning protocols.\n\n\u2022 Supports the project team during engineering studies geared toward developing the technical and business justification for engineering projects.\n\u2022 Work with clients and stakeholders from manufacturing, process development, facilities, quality assurance and validation to develop and define user requirements.\n\u2022 Responsible for identifying and refining design alternatives during conceptual schematic design evaluations.\n\u2022 Responsible for executing and/or directing, coordinating and supervising the work of consultants and engineering firms during the schematic and detailed design phases.\n\u2022 Executes and/or directs technical resources during the implementation phase (includes construction, startup, commissioning, and validation).\n\u2022 Responsible for turnover packages prepared during the detailed design phase and project close out.\n\u2022 Responsible in ensuring that all Amgen standards and procedures are followed by the project team.\n\u2022 Verifies that all change control procedures are properly documented.\n\u2022 Works closely with other discipline and/or project engineers to coordinate the design and implementation.\n\u2022 May work in as a discipline or project engineer depending on the needs of each project.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelor degree in Engineering and 8+ years of related engineering experience with four of those years engaged in projects in a manufacturing environment.\n\nDemonstrated understanding of project life cycle, versatility, adaptability, decision making skills, collaboration, accountability, problem solving skills, teamwork, and quality control on engineering projects. Position requires excellent technical writing and verbal communication skills.\n\nDemonstrated track record of being science-based, competing intensely and winning, creating value for patients, staff and stockholders, being ethical, trusting and respecting each other, working in teams, ensuring quality, and collaborating, communicating, and being accountable.\n\n? Experience with design and implementation in a manufacturing environment, and with validation and change control methodology strongly desired.\n? Knowledge and skills in Microbial and Mammalian Fermentation, Cell Culture and Purification systems strongly desired.\n? Demonstrated leadership experience\n? Project management experience\n? Technology transfer experience\n? Knowledge of cGMP pharmaceutical manufacturing process design requirements.\n? High level experience with design, programming, and commissioning activities for all automation/process systems and controllers (such as SLC, PLC, DeltaV, BMS, HMI & SCADA).\n?  Ability to review and approve engineering documentation such as requirements and design documents, I/O diagrams, one-line diagrams, panel layout diagrams, system architecture diagrams, and instrument data sheets.", "date_new": "2012-02-10 18:16:30", "url": "http://www.amgen.jobs/xml/26456571/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Mfg Projects", "reqid": "13823BR", "state": "Colorado", "state_short": "CO", "location": "Boulder, CO", "uid": 26456571}, {"country_short": "TUR", "city": "Field Based", "description": "Auto req 13899BR\nJob Posting Title Sr Biopharmaceutical Rep\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Turkey\nLocation (City) Field Based\nAmgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2012-02-09 23:45:03", "url": "http://www.amgen.jobs/xml/26445021/job", "country": "Turkey", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "13899BR", "state": null, "state_short": null, "location": "Field Based, TUR", "uid": 26445021}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13870BR\nJob Posting Title Clinical Research Medical Director - Oncology - Xgeva\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Clinical Research Medical Director is responsible for:\n\n- Supporting the development, execution and communication of the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Supporting the development of key scientific external relationships with opinion leaders\n- Participating and providing clinical input into safety and regulatory interactions\n\nKey Activities:\n\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Interpret clinical trial data\n- Participate in safety assessments\n- Participate in interactions with regulatory agencies\n- Author CSRs, publications and regulatory submissions\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL\n- Identify new clinical research opportunities\n- Support in-licensing and out-licensing activities and partner relationships\n- Support product lifecycle management for new indications as directed by Global Development Leader\n- Provide clinical content input to:\n- Regulatory interactions and documents\n- Safety interactions and documents\n- Materials to be used in Scientific Affairs\n- Materials to be used by the Commercial Organization\nBasic Qualifications - MD\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\nPreferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent\n- Experience in GU Oncology\n- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\n- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n- prior oncology clinical research / experience\n\nKnowledge\n\n- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Sound scientific and clinical judgment\n- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- Demonstrated ability as a medical expert in a complex matrix environment\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-02-09 23:44:48", "url": "http://www.amgen.jobs/xml/26445010/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Director - Oncology - Xgeva", "reqid": "13870BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26445010}, {"country_short": "ITA", "city": "Milan", "description": "Auto req 13284BR\nJob Posting Title Strategic Sourcing Sr Manager Italy \u2013 Productivity Lead\nCareer Category Supply Chain\nEmployee Subgroup Salaried FT\nCountry (State/Region) Italy\nLocation (City) Milan\nAmgen Job Description Reporting to the Affiliate Finance Director and Director Strategic Sourcing, the person will be responsible in the Italian affiliate for:\n\n- Secure the availability of goods and services in strict and consistent compliance with Amgen\u2019s requirements at minimum total cost and risk and as to local F&A.\n- Ensure effective management of local strategy development, selection and contracting processes, supply base control and performance and the operational purchasing process\nto the International Procurement Director:\n- Ensure an effective and efficient local Sourcing and Supplier management process in accordance with established Procurement policies and guidelines\n- Ensure early procurement involvement in sourcing projects\n\nThe main activities will be:\n\nLocal, ad-hoc sourcing:\n\nOpportunity identification: identify local improvement opportunities with respect to management of Purchase demand, Supply base and Total Cost on a local level\nRequirements definition: identify and define specific stakeholder requirements;\nTendering: define evaluation/selection criteria, define and manage RFI and RFP processes on the basis of the local sourcing strategy, derived from the category sourcing strategy;\nSupplier Selection: evaluate and negotiate proposals, ensure and validate selection of the best supplier;\nSupplier Contracting: complete and implement the contract in accordance with legal standards and Procurement policies and guidelines;\n\nCategory management:\n\nSupply base analysis: monitor, analyze and report Affiliate\u2019s actual spend, trends, forecasts and Supplier base data;\nStrategy development: participate in International category strategy development European Sourcing: participate in International Sourcing teams\nInfrastructure development: support Strategic Sourcing infrastructure development and integration.\n\nPurchase to pay:\n\nPurchase to pay: assist and monitor the operational purchase to pay process for the Affiliate concerned and ensure conformance to procurement process policies and guidelines\n\nSupplier performance:\n\nPerformance Monitoring: monitor and report supplier performance on the basis of pre-determined, relevant and measurable KPIs\nSupplier performance improvement: establish, agree and implement improvement plans.\n\nReporting:\n\nBenefits tracking: develop, maintain and report Key Performance Indicators that clearly reflect the achievement of objectives in each business area\nBasic Qualifications - Indirect Purchasing knowledge: sourcing process, commodity management and analysis, supplier management and development, pricing theory and policy, negotiation, supply chain, make or buy.\nBSc/HBO (technical/economic/administrative) or equivalent\n- Purchasing related training (Nevi, Isfah, CIPS, MBA)\n- Negotiation (at least 1 course)\n- At least 5 years Purchasing experience in a profit driven and international environment\n(Project) Management experience (team or direct)\n- Experience with tendering processes, supplier negotiations and contracting, including eSourcing\n- Experience with ERP\n- Computer skills (MS-office environment)and master user in Excel\n- Willingness to travel\n- Fluency in English and Italian, both in oral and written communication\nPreferred Qualifications - Business process related training\n- At least 5 years Business Process related experience in a Pharmaceutical or similar environment\n- Fluency in multiple languages\n- Skills and knowledge in Finance", "date_new": "2012-02-08 20:05:02", "url": "http://www.amgen.jobs/xml/26410392/job", "country": "Italy", "company": "Amgen", "title": "Strategic Sourcing Sr Manager Italy \u2013 Productivity Lead", "reqid": "13284BR", "state": null, "state_short": null, "location": "Milan, ITA", "uid": 26410392}, {"country_short": "TUR", "city": "Istanbul", "description": "Auto req 13648BR\nJob Posting Title Sr Biopharmaceutical Rep\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Turkey\nLocation (City) Istanbul\nAmgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2012-02-08 20:03:54", "url": "http://www.amgen.jobs/xml/26410312/job", "country": "Turkey", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "13648BR", "state": null, "state_short": null, "location": "Istanbul, TUR", "uid": 26410312}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13541BR\nJob Posting Title Sr Associate IS Bus Sys Analyst (Web)\nCareer Category Information Systems\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role is primarily responsible for working closely with internal Amgen clients, client-facing IS groups, external vendors, and IS partners to oversee & assist development of external websites and associated solutions leveraging the J2EE/.NET stacks that may or may not leverage an underlying Content Management System.\n\nResponsibilities include client engagement, monitoring emerging client needs/industry developments, requirements elicitation, process and systems analysis, identification of new capabilities/tools/automation solutions and approaches for addressing business needs, propose changes to existing service components, define standards/guidelines/processes for external website development, and supporting the development of business cases for proposed solutions.\nBasic Qualifications Master\u2019s degree\nOR\nBachelor\u2019s degree & 2 years of directly related experience\nOR\nAssociate\u2019s degree & 6 years of directly related experience\nOR\nHigh school diploma / GED & 8 years of directly related experience\nPreferred Qualifications \u2022 Web development experience in J2EE, .NET stacks\n\u2022 Ability to use a Content Management System to deploy/manage website content\n\u2022 Strong web site and page design and layout skills\n\u2022 Web usability\n\u2022 Information Architecture development skills\n\u2022 Search Engine Optimization\n\u2022 Web metrics reporting\n\u2022 Integration with Web Metric solutions\n\u2022 Unit and Integration testing\n\u2022 Implement website security\n\u2022 System analysis, integration\n\u2022 Ability to work with diverse teams\n\u2022 Vendor management\n\u2022 Technical Writing\n\u2022 Process development\n\u2022 Comfortable giving presentations to client groups\n\u2022 Ability to effectively manage client relationships\n\u2022 Ability to quickly adapt to changes in client needs and reformulate plans accordingly\n\u2022 Strong organizational and work planning skills are needed\n\u2022 Competent at using Microsoft Office technologies.\n\n\u2022 Knowledge in areas:\no Information Architecture\no Portals & Collaboration Tools\no Iterative Development\no Formalized Requirements Gathering\no Experience with LDAP, VPNs and ASP services also a plus\no Development of policies, SOPs and associated documents\no Internet protocols including: TCP/IP and HTTP and Web technologies.\n\nStrong business analysis skills are required in order to work with client organizations, understand/gather their requirements, lead functional requirements discussions, provide subject matter expertise and authority in defining use or no-use of tools and techniques, and develop/oversee development of solutions. Seeking forward looking candidates who are comfortable with a fast paced service and are able to bring innovation and thought leadership in implementation of technology solutions and tools to meet client and the service\u2019s needs.\n\nSuccessful candidates will possess strong skills in developing test case documentation and have demonstrated the ability to coordinate, lead and document formal testing of IT systems. Excellent documentation and writing skills are key. The ability to document and communicate processes and follow accepted Amgen IS policies and standards is mandatory.\n\nThe successful candidate will establish and maintain a positive business relationship with managers, staff, and external business partners that utilize the COE\u2019s services. He or she will demonstrate a thorough ability to obtain understanding of the functional area business models, processes, and priorities, and leverage that knowledge in the delivery of production solutions to meet client automation needs.\n\nCandidates must be able to work independently and provide recommendations on strategies for meeting client needs within the scope of the COE\u2019s service offerings. He or she should have the ability to see the big picture and zoom-into specific areas as and when needed.", "date_new": "2012-02-08 02:39:37", "url": "http://www.amgen.jobs/xml/26389652/job", "country": "United States", "company": "Amgen", "title": "Sr Associate IS Bus Sys Analyst (Web)", "reqid": "13541BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26389652}, {"country_short": "USA", "city": "Washington D.C.", "description": "Auto req 13703BR\nJob Posting Title Admin Coordinator - Washington, DC\nCareer Category Administrative\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - District of Columbia\nLocation (City) Washington D.C.\nAmgen Job Description The Administrative Coordinator (AC) will be primarily responsible for complex administrative support activities, supporting multiple Executive Directors/Directors/Sr Managers in the Global Government Affairs organization. Key Activities: \u2022Initiating/facilitating/participating in cross-functional team meetings \u2022Independently coordinating web-interface meetings \u2022Developing slide presentations. \u2022Scheduling interviews \u2022Assisting with special projects as requested by the Directors and others within group. \u2022 Screen and act on incoming phone calls \u2022 Maintain distribution, contact and personnel lists \u2022 Coordinate mailings and courier/deliveries \u2022 Coordinate functional processes such as invoicing and payments \u2022 Manage the administrative aspects of relationships with outside experts and vendors \u2022 Participate in department project teams \u2022 Provide backup support to additional department ACs \u2022 Update and maintain all dues, memberships, subscriptions etc. This role will leverage an experienced AC who enjoys working in a fast-paced environment, and can ensure timely coordination of the department members\u2019 below listed administrative needs. \u2022 Manage individual and team calendars (Outlook) \u2022 Coordinate local and international meetings: arrange travel, meeting arrangements, visitor accommodations \u2022 Organize meeting rooms, including logistics, catering and equipment needs \u2022 Prepare agendas and take action items as required. This role will require the incumbent to be flexible, take initiative and work well independently and in teams. This role will proactively anticipate needs, communicate expectations, disseminate and compile information. This role will leverage an individual who is detail-oriented, able to work on multiple projects simultaneously and organize and prioritize workflow. This role will require the individual to be able to handle sensitive and confidential information with diplomacy and discretion. The individual will need to take a proactive approach to identifying breakdowns in service, information flow and process, and resolve issues appropriately. This role will act as a liaison to internal department staff, cross-departmental areas, and external contacts for those individuals. This role will be called upon to interact with various levels of Amgen management and external clients. This role will call upon excellent interpersonal skills and be able to positively influence others. In order to be successful in this role the incumbent will need to be able to effectively communicate, both orally and in writing, with internal staff, supporting functional units. Modifying communication style as appropriate for the varied audience will be important. This role will be able to, with minimal direction, anticipate next steps, identify issues/problems and propose solutions. Will also demonstrate a service-oriented approach to all activities, a willingness to learn new approaches and adapt to change, and will lead by example in promoting teamwork.\nBasic Qualifications \u2022 Associate\u2019s degree & 2 years of directly related experience\nOR\n\u2022 High School diploma / GED & 4 years of directly related experience\nPreferred Qualifications Amgen experience -5+ years of experience in an administrative support role supporting large teams at different levels -Managing multiple calendars including coordination across multiple time zones \u2022Excellent written , verbal, and presentation skills in communicating key business and clinical information \u2022Advanced knowledge of MS Excel, PowerPoint, and Word (i.e. word processing, presentations, and spreadsheet skills) as well as Cognos, Sharepoint, and the Learning Management System at Amgen \u2022Experience providing administrative support to remote staff \u2022Outstanding organizational and interpersonal skills \u2022Ability to work in a fast-paced ,deadline- driven environment \u2022Discretion in dealing with proprietary information", "date_new": "2012-02-08 02:39:01", "url": "http://www.amgen.jobs/xml/26389649/job", "country": "United States", "company": "Amgen", "title": "Admin Coordinator - Washington, DC", "reqid": "13703BR", "state": "District Of Columbia", "state_short": "DC", "location": "Washington D.C., DC", "uid": 26389649}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 13373BR\nJob Posting Title Scientist - Biotech Engineering\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Washington\nLocation (City) Seattle\nAmgen Job Description A Scientist would be expected to act as a lead technical support for a pre-commercial drug product program within process development to achieve the resolution of technical issues, to author technical documents and support all technical issues around commercialization of the drug product. Support of technology transfer and site selection, equipment selection, process design, validation strategy, and relevant GMP documentation is also required.\nThe scientist applies fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve processing issues and develop a robust commercial product, as well as evaluating changes such as process improvements, equipment, scale, and raw materials Participate as author for process transfer documentation, technical reports, batch records, GMP documentation and\nregulatory filings. Travel will be required.\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or Life Sciences. 4+ years of relevant biotech experience in process development within a pharmaceutical or biotechnology corporation.\nAbility to apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to develop the drug product process, troubleshoot manufacturing operations, evaluate equipment design, and scale up the drug product process.\nExperience with process development for biologics including lyophilization cycle development.\nExperience participating in global, cross-functional teams working on technology transfer of biologics.", "date_new": "2012-02-08 02:38:38", "url": "http://www.amgen.jobs/xml/26389646/job", "country": "United States", "company": "Amgen", "title": "Scientist - Biotech Engineering", "reqid": "13373BR", "state": "Washington", "state_short": "WA", "location": "Seattle, WA", "uid": 26389646}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13751BR\nJob Posting Title Specialist IS Business Systems Analyst (IS Technical Lead / Developer Service-Now)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position will be part of the Technology Services team within the Integrated Service Management function, and will be responsible for providing application and development maintenance and administration support for the Integrated Service Management tool (ISM)\n\nThis position will be a Developer/Administrator for Service-Now Application and will work as a member of the support team to configure and maintain the Service Management tool.\n\nThis position will provide technical assistance, workflow development, and software configuration/customization. This may include but not limited to: custom reports, data imports, LDAP integration, custom scripting and third party software integrations.\n\nResponsible for the design and development of ITIL tool. Develops design and functional specifications, produces deliverables related to changes or enhancements with the tool. Responsible for Java Scripting and Configuration of tool. May be responsible for gathering, compiling and synthesizing information with regard to technology processes or systems. Includes documenting requirements, design, and producing and executing positive and negative test scripts.\n\nResponsibilities will include:\n- Providing software customization assistance including, but not limited to: screen tailoring, workflow administration, report setup, data imports, LDAP integration, custom scripting and third party software integrations\n- Answering how to\u201d technical and application configuration questions\n- Facilitating roll out of new applications and modules\n- Assisting in troubleshooting patch / release management issues\n- Aiding in translating business requirements into technical requirements\n- Helping to implement new functionality including configuration and testing\n- Writing Custom Reports\n- Writing application documentation\n- Implementing new requirements\n- Maintaining validation and training documentation\n\nThis position will be expected to develop recommendations and lead the implementation of improvements in documented practices and reports.\nBasic Qualifications - Doctorate degree\nOR\n- Master\u2019s degree & 3 years of directly related experience\nOR\n- Bachelor\u2019s degree & 5 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - Bachelor's degree in Computer Science or related field\n\n- Proven skills in Windows Administration and Java Scripting\n- ITIL tool experience\n- Experience in all aspects of SDLC from requirements, design, testing, and support\n\n- Demonstrated skills in Web Technologies or web-based scripting technology (XML, HTML, JAVA Script, AJAX, CSS, HTTP, SOAP etc.)\n- Web applications, networks, protocols and email (SMTP, POP3)\n- The ability to take complex end-user requirements to system requirements to code\n- Understanding of enterprise IT architecture\n- Working knowledge of relational databases\n- Basic understanding of ITIL v3 methodologies\n\nExperience in these areas is also preferred:\n\n- Web Services integrations\n- Experience with Service-Now.com configuration or implementation\n- Experience configuring other SaaS solutions such as Salesforce.com a plus\n- ITIL Certification\n- CMDB design and usage experience\n- Web Services integrations and experience with web services via APIs\n- Experience with IT Service Management, Service Desk, Asset Management and Change Management\n- Knowledge of LDAP - Active Directory, eDirectory, OpenLDAP; Discovery Tools; Single Sign-on using: Digested Token, SAML 1.1, SAML 2.0.\n- Experience in implementing, monitoring, analyzing and supporting IS service management processes/tool\n- Regulatory processes and controls experience, excellent documentation\n\nThe following attributes and abilities are also highly preferred:\n\n- Self-motivated, a positive can-do attitude & willingness to learn, forward thinking, assertive, and able to focus on finding and developing unique opportunities to create value by enabling and engaging in creative dialogue with various key stakeholders\n- The ability to work independently and with a team\n- Strong business analysis, data analysis, and problem analysis skills\n- Able to organize and schedule tasks, develop realistic action plans incorporating time constraints and task priorities.\n- Demonstrated ability to successfully negotiate with clients\n- Strong analytical, leadership, and project management skills as well as strong personal commitment to quality service\n- Strong presentation skills, interpersonal skills, verbal and written communications skills", "date_new": "2012-02-02 01:06:29", "url": "http://www.amgen.jobs/xml/26261227/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Business Systems Analyst (IS Technical Lead / Developer Service-Now)", "reqid": "13751BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26261227}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 13691BR\nJob Posting Title Sr Counsel - Biotech (Large Molecule)\nCareer Category Law/Legal\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nThousand Oaks\nAmgen Job Description Position may be based in our Thousand Oaks, CA or San Francisco, CA locations.\n\nThis role will be involved in patent application drafting and prosecution, research and licensing agreements, legal opinions and strategies, trademark and copyright matters, and potentially patent litigation support.\n\nThe role will be responsible for identifying patentable subject matter; drafting, filing and prosecuting patent applications; developing legal strategies relating to products and product candidates; analyzing patents and preparing infringement, validity and freedom-to-operate opinions; conducting due diligence in support of licensing activities; negotiate and draft research agreements; and provide advice and counsel to R&D and business personnel on a variety of IP related matters.\n\nWill work individually and in legal teams and cross-functional R&D and business teams.\nBasic Qualifications - JD degree from an accredited law school and admission to practice law required\n- 4 Years of experience practicing patent or intellectual property law\nPreferred Qualifications - 10 plus years of experience preferred\nExperience in all aspects of U.S. and foreign intellectual property law relating to biotechnology, preferably in the pharmaceutical industry with a law firm or corporation.\n- An advanced degree or experience in biology is considered a plus.\n- Excellent analytic, legal drafting and oral and written communication skills.\n- Strong management and leadership skills as well as a strong client service focus and the ability to work independently and in teams, efficiently, prioritize workflow, meet demanding deadlines, and manage multi-dimensional projects in a fast-paced environment.", "date_new": "2012-02-01 02:26:51", "url": "http://www.amgen.jobs/xml/26231381/job", "country": "United States", "company": "Amgen", "title": "Sr Counsel - Biotech (Large Molecule)", "reqid": "13691BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 26231381}, {"country_short": "GBR", "city": "Cambridge", "description": "Auto req 13453BR\nJob Posting Title Medical Development Sr Mgr\nCareer Category Medical Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Cambridge\nAmgen Job Description Overview:\nThe Oncology TA lead leads a high-performing office and field-based team, providing medical expertise across the organization to generate strategies, clinical data, analysis and communications that support the safe and effective use of our medicines by patients, physicians and payers .\n\nKey responsibilities\n\u2022 Set UK/Ireland goals and dashboards to evaluate performance, approving TA plans, goals, proposals and deliverables\n\u2022 Be the single point of accountability for all UK/Ireland TA activities ensuring alignment of early-stage strategy with late-stage TA objectives\n\u2022 Drive the data generation, establishing and communicating the strategy for the UK/Ireland TA\n\u2022 Manage resources, budgets and forecast accuracy within area of responsibility ensuring adequate resources and budget across all programs (study and non-study) and maintain budget accountability.\n\u2022 Assist the Medical Lead in identifying and resolving clinical/scientific issues and direct UK/Ireland Medical Advisors in navigating products through internal governance and external regulatory portals\n\u2022 Assist UK/Ireland Medical Advisors in interactions and communication with external customers, key organizations, and institutions\n\u2022 Assess risk and identifying issues, conflicts or gaps (Affiliate/Sub-Regional) across the portfolio\n\u2022 Perform portfolio level risk assessments and prioritization of programs\n\u2022 Chair Affiliate/Sub-Regional TA Team meeting and the Local Development Team (LDT)\n\u2022 Serve as a key interface to communicate Internationally and locally important issues and status of programs to Amgen IRD and UK/Ireland Management\n\u2022 Foster and improve International collaboration and coordination\n\u2022 Partner with the UK/Ireland Business Unit for all product lifecycle management activities\n\u2022 Provide input, review, approve the UK/Ireland lifecycle management plan and ensure alignment across the portfolio\n\u2022 Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio\n\u2022 Provide clinical oversight of product safety evaluation within the Affiliate/Sub-Regional TA\n\u2022 Provide support and leadership for advisory boards\nBasic Qualifications \u2022 Medical Degree (MD)\n\u2022 Extensive experience in designing and managing clinical trials across different phases of development, in providing advice to Medical Advisor within country/ region and resolving clinical trial-related issues\n\u2022 Substantial experience gained in a pharmaceutical or biotechnology company\n\u2022 Broad and formal leadership experience\nPreferred Qualifications \u2022 In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n\u2022 In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials\n\u2022 Medical knowledge in the relevant therapeutic area\n\u2022 Sound scientific and clinical judgment\n\u2022 Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups\n\u2022 Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements\n\u2022 Understanding of new drug commercialization and business practices\n\u2022 Understanding of resourcing and budgeting\n\u2022 Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment\n\u2022 Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n\u2022 Demonstrated ability to organize and lead expert Medical Advisory Panels\n\u2022 History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues\n\u2022 Track record in effectively managing risk and compliance\n\u2022 Building strong relationships with KOLs within DA\n\u2022 Coaching and mentoring Medical Advisor within a Medical Department\n\u2022 Extensive experience working in cross-functional teams\n\nCompetencies:\n\u2022 Decision Making\n\u2022 Leadership (Scientific, Technical and Departmental)\n\u2022 Problem Solving\n\u2022 Written and Oral Communication\n\u2022 Innovation\n\u2022 Initiative\n\u2022 Delivery Focus\n\u2022 Conflict management\n\u2022 KOL engagement", "date_new": "2012-02-01 02:26:20", "url": "http://www.amgen.jobs/xml/26231372/job", "country": "United Kingdom", "company": "Amgen", "title": "Medical Development Sr Mgr", "reqid": "13453BR", "state": null, "state_short": null, "location": "Cambridge, GBR", "uid": 26231372}, {"country_short": "USA", "city": "West Greenwich", "description": "Auto req 13625BR\nJob Posting Title Sr Project Mgr\nCareer Category Project Management\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen Job Description The Project Management Organization (PMO) is responsible for Program and Project Management, Project Portfolio Management and Project Support functions at the Amgen Rhode Island (ARI) site.\n\nThe Senior Project Manager position presents an opportunity for a qualified candidate to further enhance their leadership skills, apply proficiency in project management to effectively manage large, highly complex programs, demonstrate versatility, and cultivate financial acumen and overall understanding of Amgen\u2019s business.\n\nThis highly visible position interacts with all levels of the organization. The candidate must have a proven track record in project management, strong leadership and communication skills, and the ability to approach issues from a strategic perspective. This includes the ability to translate strategy into challenging, actionable objectives to effectively drive cross functional teams, advocate client positions throughout the project life cycle, and make value-based decisions.\n\nPrimary responsibilities include leadership of multi-faceted, cross-functional and global projects as well as mentoring less experienced project managers at the Amgen Rhode Island site.\n\nThe PMO leads a wide breadth of projects, including:\n\n- New Product Introductions and Tech Transfers\n- Large Capital Projects\n- Process related improvements (i.e., next generation product introductions)\n- Global System deployments (i.e., SAP/ERP/MES)\n- Operational Excellence initiatives (e.g., Business process improvements, supplier relationship initiatives, etc.)\n\nUnder minimal guidance, the candidate must manage all aspects of their project(s): planning, cost, schedule, risk, communications, resources, team dynamics and performance, implementation, monitoring, completion and follow-up.\nBasic Qualifications ? Doctorate degree & 2 years of directly related experience\nOR\n? Master\u2019s degree & 6 years of directly related experience\nOR\n? Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Project management Professional (PMP) certification\n\u2022 Strong knowledge of biotech manufacturing processes and/or Amgen information systems\n\u2022 Strong leadership and motivational skills\n\u2022 Strong project management skills\n\u2022 Experience leading large cross-functional teams\n\u2022 Demonstrated ability to forge and maintain strong relationships within multiple functional areas\n\u2022 Ability to tactfully and effectively negotiate and influence\n\u2022 Ability to communicate and present ideas to all levels of staff and management\n\u2022 Ability to multi-task and function in a dynamic environment\n\u2022 Experience leading teams or organizations (e.g. management of direct staff)\n\u2022 High proficiency in project management methodology and tools (e.g., MS Project, @RISK, etc.)\n\u2022 Understanding of operational excellence, including continuous improvement methodologies (e.g., Lean, Six Sigma, Catalyst, etc.)", "date_new": "2012-01-30 23:42:37", "url": "http://www.amgen.jobs/xml/26200954/job", "country": "United States", "company": "Amgen", "title": "Sr Project Mgr", "reqid": "13625BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 26200954}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13695BR\nJob Posting Title Health Economics Senior Manager - Bone Health\nCareer Category Health Economics\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Develops Health Economics strategies and projects that leverage the value proposition created by the Global and Regional Health Economics, Medical and Business teams. Develops, implements and oversees the health economics and outcomes projects to support the Amgen product across its lifecycle.\n\nResponsibilities:\n1. Develops Global and Regional value propositions\n2. Develops pharmacoeconomic models (cost utility, cost effectiveness, cost offset, budget impact, etc), both independently and in collaboration with vendors and key opinion leaders.\n3. Develops annual strategic plans and research projects that support the value proposition including outcomes research, patient reported outcomes, and health economics modeling\n4. Creates and maintains the Global Value Dossier\n5. Performs health economics projects from inception to completion and publication including creation of Study Concept Documents, Protocols, Analysis Plans and Final Study Reports\n6. Review and critique medical and evidence-based outcomes literature\n7. Manages researchers and health economics vendors external to the company\n8. Works with teams to create and implement payer, value and publication plans\n9. Works with Clinical Development study teams\n10. Interacts with and presents to multiple departments within Amgen:\n- Health Economists in Europe, Canada and Australia;\n- Development including Clinical Science, Epidemiology and Biostatistics;\n- Global Commercial including the Global Commercial Leader and Global Pricing;\n- and US Business Units including Product Director, Access Managers, Corporate Accounts and Global Government Affairs.\n11. Builds relationships with Key Researchers and Opinion Leaders\n12. Manages project budgets\nBasic Qualifications -Doctorate degree & 2 two years of directly related experience\nOR\n-Master\u2019s degree & 6 six years of directly related experience\nOR\n-Bachelor\u2019s degree & 8 years of directly related experience\nPreferred Qualifications -Masters, PharmD or PhD in Health Economics, Outcomes Research, Health Services Research.\n-4 or more years of experience in global outcomes research including dossier submissions for reimbursement.\n-3 or more years of experience developing pharmacoeconomic models.\n-3 or more years of experience in PRO/HRQOL research including questionnaire design, evaluation, and/or analysis.\n-Experience working with consumers of outcomes information.\n-Sophisticated modeling skills.", "date_new": "2012-01-27 20:49:31", "url": "http://www.amgen.jobs/xml/26163818/job", "country": "United States", "company": "Amgen", "title": "Health Economics Senior Manager - Bone Health", "reqid": "13695BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26163818}, {"country_short": "USA", "city": "Longmont", "description": "Auto req 13452BR\nJob Posting Title Dir EH&S\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Colorado\nLocation (City) Longmont\nAmgen Job Description Job Summary:\nAn experienced Environment, Health & Safety Director (EHS) to provides vision and strategy for site and/or global EHS initiatives. Responsible for keeping site senior management informed on the status of environment, safety and health matters affecting the site. Assists Site Quality Executive Director in formulating and executing company practices as they related to environment, safety and health performance.\nDelivers results through influence and communicating effectively with clients and practical integration of EHS with business practices. Independently take actions to drive improvement in EHS performance and practices.  Manage complex problems and coordinate the implementation of innovative solutions.\nFunctions (Duties/Accountabilities):\nEHS Management: Develop a management system which ensures that EHS is a key component of all site activities. Applies practical environment, safety, and health operating standards to ensure continuous improvement in EHS performance at the site.  Influence line management to ensure that EHS is managed by line management as a core skill. Implement CAPA program to ensure actions are taken in a timely manner for effective close out of all findings from incidents, risk assessments, inspections and audits.\nIncident management: Incident investigation and root cause analysis, reducing potentially serious incidents, injuries, environmental incidents, case management and injury prevention programs\n\nRisk Management: Risk assessment for various aspects of EHS and capable of implementing a program at all levels of the facility. Knowledge and experience of process hazard evaluation techniques such as What If, HAZOP, FMEA.\n\nSafety culture programs: Develop and implement Amgen safety culture program to integrate EHS as part of the day to day operations.  Ensure early reporting by staff of unsafe conditions and behavior and near misses.\n\nProject design review: Implement process for carrying out EHS review of projects, a management of change process, and handover and commissioning processes.\n\nContractor safety management: Ensure contractors comply with Amgen EHS requirements.\n\nEHS Program Compliance: Provide technical guidance for the implementation of Amgen\u2019s Environment, Industrial Hygiene, Occupational Health and Safety programs to ensure compliance.\n\nEngineering safety: Permit to work, Lock out tag out, confined space entry, cranes and hoist\n\nPersonal Protective Equipment:\n- Managing hazardous substances including flammable and combustible materials, biologics, regulated carcinogens and controlled substances\n- Employee exposure determinations\n- Ergonomic design and assessment\n- Fire and life safety\n- Waste management\n- Air and waste water permitting and compliance\n\nProcess safety management: Oversee management of chemical inventory and waste management programs (chemical, biohazard, radiation, universal, etc.).\n\nRegulations: Implement systems to ensure compliance with applicable EHS regulations. Evaluate existing and new regulations\u2019 impact upon Amgen operations. Develops new programs and implement changes as necessary.\n\nTraining: Implement EHS training strategy for Amgen staff & contractors and develop new training programs as required.\n\nEnvironmental Sustainability: Implement programs to ensure accurate data is collected for the sites environmental impact and to reduce the ongoing environmental impact of the site\u2019s operations.\n\nInternal Auditing: Communicate audit results to site senior management. Review findings for trends and/or improvement opportunities that affect the site.\n\nSupervision: Managing staff and/or technical personnel in multi-tiered organization.\nBasic Qualifications Doctorate degree and 4 years of directly related experience\nOR\nMaster\u2019s degree and 8 years of directly related years\nOR\nBachelor\u2019s degree and 10 years of directly related experience\nAND\n4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications MS Degree environmental, safety, industrial hygiene, technical, scientific or engineering\n\n12 or more years of experience developing and implementing EHS programs in a biotechnology/pharmaceutical company\n\nExperience in implementing an EHS management system (OHSAS 18000, ISO 14000).\n\n7 years of supervisory experience\n\nKnowledge with European regulations as they pertain to pharma/ biotech operations\n\nApplied knowledge and understanding of EHS principles and practices, regulatory standards, and requirements in context of business activities.\n\nPostgraduate professional qualification preferred (e.g. Certified safety practitioner (CSP))\n\nLeadership, team building, strong communication skills, action oriented, self starting, program development and project management.\n\nProficient in Microsoft Office and other computer software systems.\n\nGood technical & business writing skills and team skills.", "date_new": "2012-01-26 22:26:16", "url": "http://www.amgen.jobs/xml/26140230/job", "country": "United States", "company": "Amgen", "title": "Dir EH&S", "reqid": "13452BR", "state": "Colorado", "state_short": "CO", "location": "Longmont, CO", "uid": 26140230}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13582BR\nJob Posting Title Regulatory Affairs Sr Mgr (GRAAS Biosimilars-CMC)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.\n\n- Coordination of global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans\n- Development of CMC and analytical dossiers required for registration of biosimilar products\n- Management of long term CMC planning and regulatory CMC submissions for licensed products\n\nKey Activities:\nRegulatory Strategy and Filing\n- Provide expertise in the development, communication, and implementation of global CMC regulatory strategies in support of Biosimilars Operating Unit\u2019s goals and product portfolio execution\n- Ensure regulatory documents (including analytical similarity packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents as required) are developed with high quality and delivered in a timely manner\n- Lead cross-functional teams in development and submission of Quality documents, including responses to questions from regulatory authorities\n- Maintain product licenses per regulatory requirements and updated according to long-term plans\n- Support development and execution of clinical and non-clinical plans\n- Develop and deliver analytical similarity packages that meet biosimilar regulatory requirements, as directed by the RA CMC Lead\n- Deliver CMC information for submissions (including Module 3, analytical similarity assessments)\n- Prepare for and participate in CMC-related agency interactions\n- Represent RA CMC on the TOST and TOET\n- Provide CMC functional support for Amgen Biosimilars Operating Unit\n- Collaborate with other GRAAS functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices)\n- Comply with critical GRAAS CMC processes\nRegulatory Intelligence\n- Monitor, assess and implement regional CMC regulatory requirements\n- Review and assess CMC impact of health authority decisions for competitive products\n- Generate and communicate CMC intelligence to the Amgen Biosimilars Operating Unit\nCollaboration\n- Participate in vendor oversight and management for regulatory CMC operations, as required\n- Provide regulatory risk assessment to the GRAAS Biosimilars function and to CMC filing teams\n- Identify process needs to meet internal challenges\n- Escalate CMC issues, progress, and metrics to the GRAAS Biosimilars function\n- Represent Biosimilars Regulatory Affairs CMC on committees, as necessary\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - CMC-specific regulatory knowledge and experience\n- Ability to understand and communicate scientific information\n- Ability to anticipate and prevent potential issues\n- Ability to communicate regulatory requirements to ensure expectations are understood\n- Industry experience in manufacture, testing (QC/QA), or distribution\n- Global regulatory CMC knowledge and experience\n- Regulatory submissions experience\n- Working with policies, procedures and SOPs\n- Experience in analytical similarity or comparability assessments and development of associated packages", "date_new": "2012-01-25 21:04:52", "url": "http://www.amgen.jobs/xml/26111472/job", "country": "United States", "company": "Amgen", "title": "Regulatory Affairs Sr Mgr (GRAAS Biosimilars-CMC)", "reqid": "13582BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26111472}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13567BR\nJob Posting Title Regulatory Affairs Sr Mgr (GRAAS Biosimilars)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Group Purpose: To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.\n\nJob Summary:\n- Coordination of global regulatory activities relevant to the successful execution and implementation of biosimilar regulatory affairs strategies and plans\n- Development of regulatory dossiers and briefing documents required for clinical trials and registration of biosimilar products\n- Ensure compliance with regulatory requirements to support ongoing clinical trials\n- Ensure compliance with regulatory requirements for licensed products\n\nKey Activities:\nRegulatory Strategy and Execution\n- Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, MAs, and Responses to Questions for products within the biosimilars portfolio in compliance with approved filing plans, timelines, and regulatory requirements\n- Provide regulatory direction on regional regulatory requirements to optimize product development timelines\n- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning\n- Support development and execution of clinical/ non-clinical strategies\n- Provide review, input, and regulatory advice into study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports and related regulatory documents used to support product development and registration\n- Participate and collaborate with labelling teams on the development of global product labels and core data sheets to align commercial objectives with expected regulatory guidance and precedent\n- Collaborate with Amgen affiliates as required to ensure effective implementation of global regulatory strategies and plans\n- With minimal supervision, participate in development of risk management and contingency planning\n- Ensure and lead regulatory compliance for biosimilar products (eg, PMCs and other agency commitments)\nRegulatory Intelligence\n- Monitor, assess and implement regional regulatory requirements, guidelines, and policies relating to biosimilar products\n- Review and assess impact of regulatory decisions for competitive products\n- Generate and communicate biosimilar intelligence\nCollaboration\n- Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products\n- Contribute to appropriate, and participate in, vendor oversight and management for regulatory and safety operations\n- Identify process needs to meet internal challenges\n- Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function\n- Represent Biosimilars Regulatory Affairs on committees, as necessary\n\nKnowledge and Skills\n- Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes\n- Regulatory experience with product filings\n- Ability to understand and communicate scientific and clinical information\n- Ability to anticipate and prevent potential issues\n- Ability to communicate regulatory strategies and requirements to ensure expectations are understood\n- Cultural awareness and sensitivity to achieve results across different regions\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - RAC\n- Regulatory knowledge of global regulations\n- Regulatory submissions experience\n- Working with policies, procedures and SOPs\n- Interacting with regulatory agency representatives\n- Understanding of drug development", "date_new": "2012-01-25 21:04:29", "url": "http://www.amgen.jobs/xml/26111457/job", "country": "United States", "company": "Amgen", "title": "Regulatory Affairs Sr Mgr (GRAAS Biosimilars)", "reqid": "13567BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26111457}, {"country_short": "TUR", "city": "Istanbul", "description": "Auto req 12334BR\nJob Posting Title Sr Biopharmaceutical Rep\nCareer Category Sales\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Turkey\nLocation (City) Istanbul\nAmgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2012-01-17 22:01:03", "url": "http://www.amgen.jobs/xml/25943896/job", "country": "Turkey", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "12334BR", "state": null, "state_short": null, "location": "Istanbul, TUR", "uid": 25943896}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13402BR\nJob Posting Title Legal Coordinator, Employment Law\nCareer Category Law/Legal\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Legal Coordinators are primarily responsible for complex administrative support activities, which may include preparing and/or processing technical material/reports/forms using a wide variety of text editing software and managing features (formatting, editing, deleting, updating, etc.), creating, testing and implementing Microsoft Word macros and templates, and occasionally assisting supervisor in coordination of management issues, (i.e., focal reviews, goals and department/staff goals and objectives). Legal Coordinators will also manage multiple and/or complex calendars, coordinate domestic/international travel arrangements, and expense reporting. Additional responsibilities include independently coordinating calendar meetings, complex onsite/offsite meetings, leading administrative projects, providing management with status/activity reports, and selecting appropriate format for presentations. Assisting staff members with compiling documents for submissions including the formatting and distribution of submissions. Legal Coordinators will also be responsible for taking, transcribing, and distributing meeting minutes, project tracking (i.e., budget, database, timelines), as well as demonstrating the ability to interact with outside vendors and various levels of management.\nBasic Qualifications \u2022 Associate\u2019s degree & 2 years of directly related experience\nOR\n\u2022 High school diploma / GED & 4 years of directly related\nPreferred Qualifications - Large law firm or in-house law department experience highly desirable.\n- Outlook, Word, Excel and PowerPoint experience are preferred\n- Associates degree is preferred", "date_new": "2012-01-11 20:37:04", "url": "http://www.amgen.jobs/xml/25834400/job", "country": "United States", "company": "Amgen", "title": "Legal Coordinator, Employment Law", "reqid": "13402BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25834400}, {"country_short": "MEX", "city": "Mexico City", "description": "Auto req 10219BR\nJob Posting Title Product Mgr\nEmployee Subgroup Salaried FT\nCountry (State/Region) Mexico\nLocation (City) Mexico City\nAmgen Job Description 40000163, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40000163, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40000163, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2012-01-07 19:06:21", "url": "http://www.amgen.jobs/xml/25756784/job", "country": "Mexico", "company": "Amgen", "title": "Product Mgr", "reqid": "10219BR", "state": null, "state_short": null, "location": "Mexico City, MEX", "uid": 25756784}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13073BR\nJob Posting Title Global Safety Medical Director - Oncology\nCareer Category Safety\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This is an opportunity for a Medical Director to serve in a Global Safety Officer GSO role within the Oncology Therapeutic area in Amgen Global Safety.\n\nThe role is located at Amgen's headquarters in Thousand Oaks, California.\n\nThe Global Safety Medical Director (also known as the Global Safety Officer (GSO)) leads by establishing the direction and priorities of the Global Safety Team (GST) and is accountable for all product safety related GST decisions for assigned products and is the key interface between the GST, Therapeutic Area Head (TAH), Amgen Global Safety Senior Management, and other Amgen functional areas. The GSO, supported by the Global Safety Project Manager, is responsible for the timely communication of safety recommendations and/or actions from the GST to internal and external stakeholders. This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head.\n\nKey Activities:\n\nAccountable for identification, assessment, and communication of potential safety signals as leader of GST pharmacovigilance activities\n\nGST representative on the PST (commercialization) accountable for GST PST deliverables\n\nLead response to regulatory safety queries\n\nLead development of strategy and creation of product risk management plans including maintenance and updates\n\nAccountable for Global Safety Strategic Plan (GSSP)\n\nSafety representative for assigned products at meetings with Regulatory authorities, data safety monitoring committees, advisory boards\n\nParticipate in planning, review and sign off of clinical trial safety documents for content including:\no Clinical Summary of Safety (CSS)\no 120 Day safety update\no Protocol safety sections\no CSRs\no ICFs\no Study safety monitoring plans\no Investigator Brochures\nBasic Qualifications MD or DO degree from an accredited medical school\n\n2+ years of safety experience\n\nCompletion of an accredited medical or surgical residency\nOR\nClinical experience in either an accredited academic setting or private practice (including hospital based) setting\nPreferred Qualifications Drug safety, biotech/pharmaceutical or regulatory agency experience\n\nBoard Certification by an accredited medical or surgical board e.g. ABIM, ABMS, EUMS", "date_new": "2011-12-23 19:32:33", "url": "http://www.amgen.jobs/xml/25538814/job", "country": "United States", "company": "Amgen", "title": "Global Safety Medical Director - Oncology", "reqid": "13073BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25538814}, {"country_short": "GBR", "city": "Uxbridge", "description": "Auto req 13137BR\nJob Posting Title Regulatory Affairs Mgr\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Uxbridge\nAmgen Job Description 40001053, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40001053, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40001053, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2011-12-21 22:00:18", "url": "http://www.amgen.jobs/xml/25502621/job", "country": "United Kingdom", "company": "Amgen", "title": "Regulatory Affairs Mgr", "reqid": "13137BR", "state": null, "state_short": null, "location": "Uxbridge, GBR", "uid": 25502621}, {"country_short": "CHE", "city": "Zug - HQ", "description": "Auto req 13040BR\nJob Posting Title Regional Access Lead\nCareer Category Government Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) Switzerland\nLocation (City) Zug - HQ\nAmgen Job Description The person must oversee and coordinate development and implementation of strategies in Emerging Europe (Russia, Turkey, MEA) to secure/maintain access at optimal prices for all Amgen in-market and launching products. This individual must work with collaborators in the IP3 and IHE organization as well as the Emerging Markets Europe Team, distributors, partners, and the individual Affiliate Value & Access Leads to translate\u201d product strategy into specific operational tactics that are most effective at a country-specific level.\n\nInternal Accountabilities\n\n\u2022 Partner with Executive Director, ICO EM Europe, to understand strategic business imperatives and access objectives\n\u2022 Foster collaboration with cross-functional partners as well as PALs and Affiliate V&A Leads in support of access in EM Europe\n\u2022 Ensure close partnership with IHE Lead in EM Europe to align strategy and evidence generation to support value proposition\n\u2022 Ensure close partnership with International Governmental Affairs Lead in EM Europe to develop optimal approach with governmental payers\n\u2022 Ensure close partnership with International Pricing and Contracting Lead in EM Europe to align pricing and contracting strategies with overall access plans\n\nAccountabilities for External-Facing Activities\n\n\u2022 Anticipate changing payer landscape across the EM-Europe region by building and maintaining deep understanding and knowledge of payers, including emerging trends that can impact access for Amgen products\n\u2022 Support local strategies and execute regional strategies within EM Europe to collaborate proactively with payers and HTAs, particularly in understanding payer perceptions, engaging in discussions of our pipeline evidence generation plans, and fostering collaborative relationships.\n\u2022 Coordinate with ICO Pricing and Contracting EM Lead, and EM Team, as well as Affiliate V&A Leads to ensure robust price and contracting strategies across the portfolio in EM Europe and consider alternative pricing mechanisms as needed to secure access (Support ICO Pricing and Contracting). Ensure appropriate business case development and assessment of trade-offs when considering price reductions to secure reimbursement\n\u2022 Coordinate with IHE EM Europe Lead and Affiliate V&A Leads to ensure robust value evidence generation and articulation of product value that is aligned with access strategies in EM Europe (Support IHE)\n\u2022 Partner with HTA and Payment Policy Team and Affiliate V&A Leads to understand key policy issues and inform Amgen policy positions in order to shape the policy landscape (Support HTA and Payment Policy Team)\n\u2022 Drive development and implementation of access strategies within EM Europe across the portfolio\n\u2022 Coordinate access training and best-practice sharing across EM Europe, especially among affiliates that share similar pricing and reimbursement structures\n\nDeliverables\n\n\u2022 Emerging Europe Payer Situational Analysis: annual snapshot of reimbursement planning assumptions including identification of evolving trends\n\u2022 Payer Research: Primary and secondary research with payers within the Emerging Markets Europe to answer specific questions needed to refine local access strategies. Intended to supplement research done by GP3 and other regional V&A colleagues. Includes:\n\u2022 Emerging Markets Europe sections of ICO Product Value and Access Plans (Collaborate with PALs) and Global Payer Plans (Collaborate with GPLs)\n\u2022 Affiliate/Distributor/Partner Access Plans (Collaborate with and provide dotted-line supervision to Affiliate V&A Leads; review plans with assigned personnel from distributors and partners)\n\u2022 Achievement of access plan: price at or above target, timely reimbursement when deemed desirable for appropriate target population\nBasic Qualifications \u2022 Higher education (University degree) and an MBA is highly valued\n\u2022 At least 2-3 years of experience in a similar position\n\u2022 Strong understanding of European Emerging Markets payer environment and demonstrated capability/experience in coverage and reimbursement, pricing and contracting, value drivers and value communication, value evidence, health technology assessment, HTA and payment policy\n\u2022 Strong leadership skills with demonstrated ability to lead cross-functional teams and engage in productive debate and collaboration with senior leaders across the organization\n\u2022 Excellent communication skills, including interpersonal skills to foster collaboration and succeed in a highly matrixed environment\n\u2022 Strong oral/written presentation skills\n\u2022 Strong strategic planning skills\u2014both at the product level as well as at the country (cross-portfolio) level\n\u2022 Ability to conduct situation analysis of external pricing and reimbursement environment and to synthesize relevant information to support development of country-specific strategic plans\n\u2022 Ability to identify the most compelling way in which to demonstrate and communicate product value to payers\n\u2022 Capability to interact with external stakeholders at multiple levels and to influence course of action through value communication, policy arguments, and negotiation\nPreferred Qualifications \u2022 Customer and HTA agency engagement\n\u2022 Direct payer experience and/or experience in product commercialization desirable\n\u2022 Regional or global experience strongly preferred\n\u2022 Strategic planning and health policy experience strongly preferred\n\u2022 Strong understanding of strategic pricing and contracting, including innovative approaches such as risk-sharing deals\n\u2022 Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies in order to understand implications for value to payers", "date_new": "2011-12-16 19:10:56", "url": "http://www.amgen.jobs/xml/25420880/job", "country": "Switzerland", "company": "Amgen", "title": "Regional Access Lead", "reqid": "13040BR", "state": null, "state_short": null, "location": "Zug - HQ, CHE", "uid": 25420880}, {"country_short": "MEX", "city": "Field Based", "description": "Auto req 10246BR\nJob Posting Title Sr Biopharmaceutical Rep\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Mexico\nLocation (City) Field Based\nAmgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2011-12-10 21:07:25", "url": "http://www.amgen.jobs/xml/25288986/job", "country": "Mexico", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "10246BR", "state": null, "state_short": null, "location": "Field Based, MEX", "uid": 25288986}, {"country_short": "MEX", "city": "Field Based", "description": "Auto req 10253BR\nJob Posting Title Sr Biopharmaceutical Rep\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Mexico\nLocation (City) Field Based\nAmgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2011-12-09 20:24:33", "url": "http://www.amgen.jobs/xml/25276926/job", "country": "Mexico", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "10253BR", "state": null, "state_short": null, "location": "Field Based, MEX", "uid": 25276926}, {"country_short": "MEX", "city": "Field Based", "description": "Auto req 10251BR\nJob Posting Title Sr Biopharmaceutical Rep\nEmployee Subgroup Sales Incentive FT\nCountry (State/Region) Mexico\nLocation (City) Field Based\nAmgen Job Description 40002031, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40002031, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40002031, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2011-12-08 21:29:22", "url": "http://www.amgen.jobs/xml/25259576/job", "country": "Mexico", "company": "Amgen", "title": "Sr Biopharmaceutical Rep", "reqid": "10251BR", "state": null, "state_short": null, "location": "Field Based, MEX", "uid": 25259576}, {"country_short": "MEX", "city": "Mexico City", "description": "Auto req 10226BR\nJob Posting Title Product Mgr\nEmployee Subgroup Salaried FT\nCountry (State/Region) Mexico\nLocation (City) Mexico City\nAmgen Job Description 40000163, Amgen Job Description To Be Added When Table Structure is Built\nBasic Qualifications 40000163, To Be Added When Table Structure is Built- Basic Qualifications\nPreferred Qualifications 40000163, To Be Added When Table Structure is Built, - Preferred Qualifications", "date_new": "2011-12-06 19:04:36", "url": "http://www.amgen.jobs/xml/25209001/job", "country": "Mexico", "company": "Amgen", "title": "Product Mgr", "reqid": "10226BR", "state": null, "state_short": null, "location": "Mexico City, MEX", "uid": 25209001}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12719BR\nJob Posting Title Sr Associate IS Bus Sys Analyst (SharePoint)\nCareer Category Information Systems\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Ideal Candidate will be a highly motivated, detail oriented, and self-sufficient individual with strong technical and communication skills to assist in maintaining our SharePoint infrastructure including SharePoint 2010 and SharePoint 2007 farms. As part of the growing Web and Collaboration group, the candidate will work closely with other administrators, developers, architects and business analysts.\n\nThis position will play a strong technical role in providing SharePoint expertise to the Web Services COE. Responsibilities may include system ownership, custom development, technical troubleshooting, metrics development, basic architectural analysis, and vendor management. Candidates should possess a strong ability to learn new technologies, and be able to work in a high pressure, fast paced environment.\nBasic Qualifications \u2022 Master\u2019s degree\nOR\n\u2022 Bachelor\u2019s degree & 2 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 6 years of directly related experience\nOR\n\u2022 High school diploma / GED & 8 years of directly related experience\nPreferred Qualifications Excellent documentation and writing skills are crucial. The ability to develop, document and communicate processes and follow accepted Amgen IS policies and standards is mandatory.\n\nCandidates must be able to work independently and provide recommendations on strategies for meeting client needs within the scope of the COE\u2019s service offerings. He or she should have the ability to see the big picture and zoom-into specific areas to provide a creative approach to problem solving, innovation and issue resolution. The Candidate should have good interpersonal skills and the ability to communicate and collaborate proactively with others.\n\nExperience with software development processes including source code control, functional and performance testing, and technical documentation, as well as, experience managing an enterprise-class system is highly desired.\n\n\u2022 SharePoint 2007 or SharePoint 2010\n\u2022 Formalized requirements gathering\n\u2022 Active Directory or similar authentication protocols\n\u2022 Working knowledge of SQL Server database architecture\n\u2022 Microsoft Online Services (BPOS/Office365)\n\u2022 Microsoft Server Administration\n\u2022 Software Development Methodologies\n\u2022 Unit and Integration Testing\n\u2022 Object-Oriented Programming Languages (i.e. C#)\n\u2022 Web Technologies", "date_new": "2011-12-04 19:40:37", "url": "http://www.amgen.jobs/xml/25175614/job", "country": "United States", "company": "Amgen", "title": "Sr Associate IS Bus Sys Analyst (SharePoint)", "reqid": "12719BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25175614}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12909BR\nJob Posting Title Reimbursement Director - Emerging Markets, Global Pricing & Payor Planning\nCareer Category Government Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Participate as a member of Amgen's Global Pricing and Payer Planning Team with specific focus on Asia and/or Latin America. The global team is responsible for strategic planning to support value and access for all Amgen molecules in development, beginning in Phase I-II and extending throughout commercialization across the Amgen portfolio. This includes lifecycle planning and access support for our inline molecules. Additionally, the team is responsible for global strategic pricing, including recommendations for global price bands and launch sequence. As a global function, this team is responsible for global pricing & access strategy across all regions, including those in Emerging Markets.\n\nEach Director in Emerging Markets will cover a specific region and will represent payer needs of that region and be a resource to the Global Payer Leaders. He/she will assess the pricing and access environments for various markets and the associated implications for the Amgen portfolio. Additional responsibilities will include development of processes/procedures to incorporate value & access activities for Asia and/or Latin America into the commercialization process and deliverables.\n\nThe Global Payer Leaders represent payer needs on the multi-disciplinary Product Strategy Team for one or more molecules. They also lead Global Payer Team(s) that support the payer planning process, including the situation analysis and the creation of global payer plans.\n\nEach global payer plan integrates coverage and reimbursement, pricing, value evidence, and policy into the development of a strategic plan that supports the overarching commercial objectives and links to the clinical attributes of the molecule. The plan elucidates and communicates the strategies and tactics to secure and maintain access throughout the lifecycle of a specific molecule.\n\nEach member of the team must work collaboratively across functions to ensure a comprehensive view of his/her assigned product/region and create and maintain strong collaborative working relationships with key stakeholders. These stakeholders include colleagues in marketing, development, health economics, regulatory, operations, and government affairs. The individual must also oversee and conduct relevant payer/pricing research and integrate cross-functional information to develop and communicate strategy.\n\nIn addition to product-specific or regional responsibilities, each team member also participates in one or more cross-portfolio projects each year. These projects either serve to advance the team\u2019s knowledge of and readiness for the global payer environment, support specific market or product assessments, or attempt to influence payer policy development. Examples include: Payer assessments to support potential mergers/acquisitions, exploration of new payer trends (e.g., bundling), or development of a policy white paper to shape external price and reimbursement policies in the global arena.\nBasic Qualifications \u2022 Doctorate degree & 4 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 8 years of directly related years\nOR\n\u2022 Bachelor\u2019s degree & 10 years of directly related experience\nPreferred Qualifications \u2022 Strong understanding of pricing, payer and access environments in emerging markets in Asia and Latin America, including local pricing and access strategies; affordability issues and healthcare reform and future trends\n\u2022 Previous assignment with responsibility in Asia and/or Latin America\n\u2022 Understanding of payer environment, both within the US and globally, including coverage and reimbursement, pricing, value drivers, formulary management, health technologies assessment, health policy\n\u2022 Ability to conduct situation analysis of external pricing and reimbursement environment and synthesize relevant information to develop strategic plans\n\u2022 Ability to conduct qualitative and quantitative pricing studies and to formulate price policy recommendations\n\u2022 Ability to formulate health policy strategy and implement these strategies to shape external pricing and reimbursement environment\n\u2022 Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies, in order to understand implications for value to payers\n\u2022 Excellent communication skills, including interpersonal skills to foster collaboration and succeed in a highly matrix environment; strong oral/written presentation skills\n\u2022 Demonstrated success as a team leader with strong team management skills\n\u2022 Direct payer experience and/or experience in product commercialization desirable\n\u2022 Strategic planning and health policy experience strongly preferred\n\u2022 Pharmaceutical pricing experience strongly preferred\n\u2022 Oncology pricing, reimbursement, and access experience desirable", "date_new": "2011-12-02 22:31:03", "url": "http://www.amgen.jobs/xml/25162788/job", "country": "United States", "company": "Amgen", "title": "Reimbursement Director - Emerging Markets, Global Pricing & Payor Planning", "reqid": "12909BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25162788}, {"country_short": "USA", "city": "West Greenwich", "description": "Auto req 12850BR\nJob Posting Title Sr Specialist Manufacturing\nCareer Category Manufacturing\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Rhode Island\nLocation (City) West Greenwich\nAmgen Job Description Manufacturing Senior Specialist Description:\n\nIndependently lead the execution of manufacturing/quality systems such as non-conformance investigations, process validation, major change control initiatives, development of staff training, new product introductions, and corrective and preventative actions.\n\nApply advanced process, operational, scientific expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as the primary production process owner for operations and assist with system ownership responsibilities.\n\nIndependently make complex decisions regarding operations, process or business practices. Lead cross-functional teams through implementation of major projects, corrective and preventative actions.\n\nApplied Process Expertise\n1. Serve as subject matter expert in manufacturing.\n2. Provide real time support for production manufacturing failures and recovery.\nNon-Conformance and CAPA\n3. May be responsible for managing the site NC and CAPA program for manufacturing.\nProcess and Equipment Validation\n4. May serve as a liaison and coordinator for manufacturing validation activities.\n5. Lead process validation projects.\nCompliance\n6. Support regulatory inspections by directly interfacing with inspectors to review batch records, process validation, non-conformances, etc.\n7. Present process overviews to inspectors and accompany inspectors on tours of process areas.\n8. May serve as a quality system owner.\nChange Control\n9. Serve as a manufacturing change owner for major change controls\nProjects and Initiatives\n10. Serve as a project manager of cross-functional projects.\n11. May represent manufacturing on site and global teams and initiatives.\n\n** Other functions that may be assigned\nBasic Qualifications Doctorate degree and 2 years of directly related experience\n\nOR\n\nMaster\u2019s degree and 6 years of directly related experience\n\nOR\n\nBachelor\u2019s degree and 8 years of directly related experience\n\nOR\n\nAssociate\u2019s degree and 10 years of directly related experience\n\nOR\n\nHigh school diploma / GED and 12 years of directly related experience\nPreferred Qualifications Scientific degree in Life Sciences or Physical Sciences or Applied\nEngineering or Manufacturing Technologies\n\nPrevious technical experience managing people, and leading teams on major\nprojects, initiatives or programs\n\nAseptic processing practical experience\n\nDemonstrated proficiency of written and verbal communication skills\n(including technical writing and technical presentations) Ability to communicate and collaborate effectively with technical and senior management staff.\n\nTrack record of increasingly complex manufacturing or manufacturing support\nexperience in biotechnology, pharmaceuticals or a related industry\n\nExperience that has provided the candidate with a detailed understanding of\nthe regulatory and compliance environment, the GMP processes and the\nbusiness processes associated with typical biotechnology / pharmaceutical\nmanufacturing operations\n\nExperience leading cross-functional teams in investigations into manufacturing deviations and determination of potential manufacturing impact and root cause, and application of corrective actions.\n\nAble to solve complex problems and make scientific risk based recommendations under ambiguous circumstances\n\nExperience representing Amgen while interacting with representatives of regulatory agencies.\n\nExperience in managing multiple, competing priorities in a fast paced environment.", "date_new": "2011-12-02 22:30:56", "url": "http://www.amgen.jobs/xml/25162784/job", "country": "United States", "company": "Amgen", "title": "Sr Specialist Manufacturing", "reqid": "12850BR", "state": "Rhode Island", "state_short": "RI", "location": "West Greenwich, RI", "uid": 25162784}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 9815BR\nJob Posting Title Health Economics Senior Manager - Oncology\nCareer Category Health Economics\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Assists in the development of Health Economics strategies and leads projects that leverage the value proposition created by the Global and Regional Health Economics, Medical and Business teams. Develops, implements and oversees health economics and outcomes projects to support the Amgen product across its lifecycle.\n\nResponsibilities:\n1. Assists in the development of Global and Regional value propositions\n2. Develops pharmacoeconomic models (cost utility, cost effectiveness, cost offset, budget impact, etc), both independently and in collaboration with vendors and key opinion leaders.\n3. Assists in the development of annual strategic plans and research projects that support the value proposition including outcomes research, patient reported outcomes, and health economics modeling\n4. Assists in the creation and maintenance of the Global Value Dossier\n5. Performs health economics projects from inception to completion and publication including creation of Study Concept Documents, Protocols, Analysis Plans and Final Study Reports\n6. Review and critique medical and evidence-based outcomes literature\n7. Manages health economics vendors external to the company\n8. Works with teams to create and implement payer, value and publication plans\n9. Works with Clinical Development study teams\n10. Interacts with and presents to multiple departments within Amgen:\n- Health Economists in Europe, Canada and Australia;\n- Development including Clinical Science and Biostatistics;\n- Global Commercial including the Global Commercial Leader and Global Pricing;\n- and US Business Units including Product Director, Access Managers, Corporate Accounts and Global Government Affairs.\n11. Builds relationships with Key Researchers and Opinion Leaders\n12. Manages project budgets\nBasic Qualifications -Doctorate degree & 2 two years of directly related experience\nOR\n-Master\u2019s degree & 6 six years of directly related experience\nOR\n-Bachelor\u2019s degree & 8 years of directly related experience\nPreferred Qualifications -Masters, PharmD or PhD in Health Economics, Outcomes Research, Health Services Research.\n-3 or more years of experience in global outcomes research including dossier submissions for reimbursement.\n-3 or more years of experience developing pharmacoeconomic models.\n-3 or more years of experience in PRO/HRQOL research including questionnaire design, evaluation, and/or analysis.\n-Experience working with consumers of outcomes information.\n-Sophisticated modeling skills.", "date_new": "2011-12-01 22:28:45", "url": "http://www.amgen.jobs/xml/25141667/job", "country": "United States", "company": "Amgen", "title": "Health Economics Senior Manager - Oncology", "reqid": "9815BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25141667}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12946BR\nJob Posting Title Business COE Mgr\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This role will consist of supporting ongoing business processes and systems for master data and security in the ERP system.\n\nThe manager will support an ongoing system of services and controls over master data to assure accuracy and integrity, which in turn provides a reliable basis for sustainable business processes and decision making. The governance of master data is required to ensure consistency (i.e. global compliance with defined uses) and usage across processes and systems with a scope of Material, Customer, Vendor, Employee, and Asset (WBS Element). The manager will also support the goals of Amgen\u2019s business units by assuring the appropriate access to ERP as well as specific identified systems (e.g., GCPS, eFinity), in compliance with various rules and regulations with respect to Amgen\u2019s ERP framework, i.e. SOX, GMP, Unblinding, Privacy.\n\nSpecifically this role will:\n\n\u2022 Develop and support SAP master data and security governance and control systems\n\u2022 Drive value-add improvement of security and master data management especially in the ERP system\n\u2022 Manage and develop data conversions, mass updates, and data-quality reports/metrics\n\u2022 Monitor SAP data quality\n\u2022 Protect SAP master data design integrity\n\u2022 Assess proposed changes for SAP master data impact\n\u2022 Monitor ERP access via SOX 40.1.3 SAP Security Monitoring\n\u2022 Support SOX Process Owners\u2019 and business leads with their quarterly SOX certification processes and related audit observations\n\u2022 Authorize changes to security roles, limiting the risk of segregation of duties occurrences, and maintaining the confidentiality of restricted information\n\u2022 Monitor all security role changes promoted to production\n\u2022 Demonstrate thorough understanding of business processes and priorities as related to the ERP system\n\u2022 Lead cross-functional teams\n\u2022 Participate in key projects\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Understanding of SAP master data and/or security\n\u2022 SAP experience using Virsa or GRC or equivalent software\n\u2022 Prefer 3 years of experience in a business function using an ERP system\n\u2022 Experience with access controls/design in IS systems\n\u2022 Experience in internal controls design and operational effectiveness\n\u2022 Computer related system qualification in a regulated industry\n\u2022 Experience defining data-conversion requirements and/or review of data for an ERP implementation\n\u2022 General understanding of Biotech/Pharmaceutical company operations\n\u2022 Understanding of ETL (extract, transform, load)\n\u2022 Understanding of systems outside of ERP, such as Ariba, EDI, Maximo, WERUM is a plus.\n\u2022 CranSoft experience a plus\n\u2022 Minimum 6 years of experience working with an ERP system\n\u2022 Firm understanding of relational databases\n\u2022 Experienced in SQL Server queries or equivalent basic programming\n\u2022 Information Systems Audit and/or SOX certification experience\n\u2022 Skilled at planning and project management\n\u2022 Competencies include business analysis and process mapping\n\u2022 Ability to work independently under minimal direction\n\u2022 Effective team member\n\u2022 Excellent written and verbal communication skills\n\u2022 Detail oriented; excellent organizational and analytical skills\n\u2022 Positive attitude and a strong work ethic", "date_new": "2011-11-29 18:32:37", "url": "http://www.amgen.jobs/xml/25085030/job", "country": "United States", "company": "Amgen", "title": "Business COE Mgr", "reqid": "12946BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25085030}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12729BR\nJob Posting Title Biomedical Data Stewardship Sr Manager\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 Drive and facilitate the expansion of data presentation standards within GBDS taking primary responsibility for standardizing the presentation of clinical trial results in Tables, Figures and Listings. The role is positioned within the Biomedical Data Stewardship (BMDS) organization and the successful candidate would work alongside other BMDS staff in the development of end-to-end data standards and ensure that TFL requirements are considered in the development of collection standards.\n\n\u2022 Lead the Global Standardized Data Presentation Governance Committee\n\n\u2022 Lead the continuous improvement of data presentation processes and supporting technology\n\nResponsibilities:\n\n\u2022 Ensuring best data presentation practice through leadership of cross-functional Global Standardized Data Presentation Governance Committee\n\n\u2022 Maintaining compliance and compatibility with CDISC standards particularly ADaM.\n\n\u2022 Contributing to the development and strategy of the GBDS Data Stewardship organization\n\nKey Activities:\n\n\u2022 Collaborate cross-functionally and within GBDS Data Stewardship to drive forward compliance with standards, processes and training\n\n\u2022 Track key metrics and reporting to GBDS and R&D Senior Management\n\n\u2022 Lead, motivate and develop the Global TFL Committee\n\n\u2022 Develop and maintain strong working relationships with key stakeholders\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - Bachelors degree in statistics/ biostatistics, programming, life science, computer science\n\n- 8 years work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena\n\n- 3+ years experience in a global organization\n\n- Demonstrated ability to influence decision making\n\n- Development of policies and SOPs\n\n- Experience collaborating on global cross-functional teams\n\n- Knowledge of project management, documentation writing, training, and compliance\n\n- Interest in process improvement methodologies\n\n- Use of software and data applications within drug development\n\n- Appreciation of computer system architecture and hardware", "date_new": "2011-11-28 21:33:28", "url": "http://www.amgen.jobs/xml/25067075/job", "country": "United States", "company": "Amgen", "title": "Biomedical Data Stewardship Sr Manager", "reqid": "12729BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25067075}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 12764BR\nJob Posting Title Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nThousand Oaks\nAmgen Job Description This role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site.\n\nThe CDM Systems Mgr \u2013 EDC Operations is the technical Subject Matter Expert and point-of-contact to ensure electronic clinical data management operations of Amgen\u2019s global Electronic Data Capture Operations service. The manager will have operational responsibility for delivery of electronic data collection systems such as Medidata Rave and Oracle InForm. These responsibilities include the delivery of EDC system capabilities, design and implementation of key system integrations, and the development of system-related EDC best practices.\n\nThe position is expected to partner effectively with other CDM Systems staff to seamlessly ensure high quality deliverables such as EDC platform upgrades, EDC architecture design, integrations with internal and external clinical systems, custom report programming, and other clinical data management activities related to the use electronic data capture technology. Through active service management of service providers the manager is responsible for representing Amgen in supporting the Operational Management Team and Functional Management Team governance bodies in partnership with Amgen Global Supplier Services, ensuring quality service delivery and supplier performance.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 3+ or more years of experience in a technical role within clinical data management, clinical development, or IS/IT\n\u2022 Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Experience successfully implementing and operating clinical data management collections systems specifically EDC platforms such as Medidata Rave and/or Oracle InForm\n\u2022 Medidata Rave, Oracle InForm hands-on operational and system knowledge desirable\n\u2022 Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary\n\u2022 Knowledge of ITIL v3 and basic Industry IS best practices\n\u2022 Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills\n\u2022 Excellent time management and organization skills required\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\u2022 Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable\n\u2022 Leadership Skills : The manager, EDC Operations will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will have extensive clinical trial technical experience and leadership expertise. He or she will have substantial technical background to deliver the EDC operations associated with the Amgen portfolio. With strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues.\n\nThe ideal candidate has a proven track record and experience in either working in and/or leading a technical team. The candidate must be able to represent Amgen\u2019s business requirements and needs by effective partnering and working with outsourced service delivery partners such as an FSP, ensure operational experience with clinical database management systems (preferably Medidata Rave and Oracle InForm) and have strong communication skills to maintain a high level of transparency between CDM systems centers of excellence, clinical study team members, CDM business units, and other stakeholders.", "date_new": "2011-11-28 21:31:18", "url": "http://www.amgen.jobs/xml/25067023/job", "country": "United States", "company": "Amgen", "title": "Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations", "reqid": "12764BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 25067023}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12650BR\nJob Posting Title Regulatory Affairs Sr Mgr (device)\nCareer Category Regulatory\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The RA CMC Group is responsible for generation of the global regulatory strategy and providing feedback to the team for plans and execution of the strategy. Facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.\n\nJob Summary:\nDevelop and implement regulatory strategies to support both new and existing combination products and innovative delivery devices.\n\nKey Activities:\n\u2022 Provide strategic expertise regarding regulatory requirements for drug delivery device related projects\n\u2022 Interface with Regulatory Authorities as appropriate\n\u2022 Work in conjunction with Global RA product leads and Regional RA representatives\n\u2022 Serve as Regulatory Affairs representative on Cross Functional Teams regarding drug delivery devices\n\u2022 Support Regulatory Filings and provide team guidance regarding:\no US 510(k) filings\no CE Mark requirements\no Device quality management system requirements\no ISO requirements\no Clinical requirements for drug delivery devices\no Device registration maintenance including Registration renewals\no Complaints and Recalls\n\u2022 Review and approve selected regulatory documents\n\u2022 Represent Regulatory Affairs to outside departments, product teams and regulatory agencies\n\u2022 Represent Amgen at external events (PhRMA, PDA, ISPE, BIO, etc.), as appropriate\n\u2022 Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts\n\u2022 Serve as the primary resource within the RA-CMC team to support drug/device combination products or other drug delivery device projects\nBasic Qualifications \u2022 Doctorate degree and 2+ years of directly related experience\nOR\n\u2022 Master\u2019s degree and 6+ years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree and 8+ years of directly related experience\nOR\n\u2022 Associate\u2019s degree and 10+ years of directly related experience\nOR\n\u2022 High school diploma / GED and 12+ years of directly related experience\nPreferred Qualifications - Degree in Life Sciences, Engineering or related field\n- 7+ years of related experience in the pharmaceutical/biotechnology or medical device industry\n- 5+ years experience in Regulatory Affairs\n- Regulatory experience with Drug/Device combination products or drug delivery device product filings a requirement\n- Ability to work within a matrix team environment\n- Able to operate in a fast paced, dynamic environment\n- Able to manage and execute activities to meet agreed upon timelines\n- Strong oral and written communication skills\n- Strong negotiating and leadership skills\n- International experience \u2013 preferred", "date_new": "2011-11-03 23:36:13", "url": "http://www.amgen.jobs/xml/24581799/job", "country": "United States", "company": "Amgen", "title": "Regulatory Affairs Sr Mgr (device)", "reqid": "12650BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 24581799}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12623BR\nJob Posting Title Sr Engineer - Facilities/Utilities\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as the plant engineer and system owner for facility/utility systems and equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; directing and coordinating equipment maintenance to improve reliability; and applying advanced engineering principles to the design and implementation of new equipment.\n\u2022 Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities).\n\u2022 Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred.\n\u2022 Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)\n\u2022 Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.\n\u2022 Responsibilities will include support of capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations.\n\u2022 Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.\n\u2022 Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise.\n\u2022 Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of experience directly related to the job\nOR\nBachelor\u2019s degree & 5 years of experience directly related to the job\nOR\nAssociate\u2019s degree & 10 years of experience directly related to the job\nOR\nHigh school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications \u2022 Bachelor\u2019s degree in Chemical Engineering or Mechanical preferred\n\u2022 6+ years of relevant work experience with 5+ years experience in operations/manufacturing environment\n\u2022 Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices.\n\u2022 Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.\n\u2022 Ability to apply advanced engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n\u2022 Strong leadership, technical writing, and communication/presentation skills are required.\n\u2022 Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.\n\u2022 Direct experience in equipment engineering and troubleshooting with compendial water systems (ie. Water for Injection, Purified Water, and Clean Steam), plant utility systems (eg. clean gases, chilled water, plant steam), and clean room HVAC systems.\n\u2022 Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices.\n\u2022 Experience in design and startup engineering directly related to bulk biopharmaceutical production including facility design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.\n\u2022 Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.", "date_new": "2011-11-01 22:17:20", "url": "http://www.amgen.jobs/xml/24526977/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Facilities/Utilities", "reqid": "12623BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 24526977}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12624BR\nJob Posting Title Sr Engineer - Process Equipment\nCareer Category Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 As a member of the Clinical Bulk Facilities & Engineering organization, this position serves as a project/plant engineer for facility systems and process equipment in a bulk biopharmaceutical manufacturing facility. Responsibilities include applying advanced engineering principles to the design and implementation of new equipment; providing operational support, troubleshooting, and optimization of assigned manufacturing process equipment; and directing and coordinating equipment maintenance to improve reliability.\n\u2022 This position serves as a lead or discipline engineer for capital projects. This role involves the application of advanced process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should understand engineering processes from initial conceptualization through project turnover to operations.\n\u2022 Ensures the logical, systematic translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.\n\u2022 Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields; and ability to employ advanced techniques within area of engineering expertise.\n\u2022 Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.\n\u2022 Supports system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield enhancement opportunities).\n\u2022 Lead technical root cause analysis, incident investigations, and troubleshooting on equipment (mechanical, electrical, instrumentation and control system problems). Previous formal training and/or demonstrated experience is preferred.\n\u2022 Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)\n\u2022 Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of experience directly related to the job\nOR\nBachelor\u2019s degree & 5 years of experience directly related to the job\nOR\nAssociate\u2019s degree & 10 years of experience directly related to the job\nOR\nHigh school diploma / GED & 12 years of experience directly related to the job\nPreferred Qualifications \u2022 Master\u2019s degree in Chemical Engineering or Bioengineering preferred\n\u2022 8+ years of relevant work experience with 7+ years experience in operations/manufacturing environment\n\u2022 Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.) is critical. Detailed understanding of industry regulations and ability to interpret in establishing current practices.\n\u2022 Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.\n\u2022 Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.\n\u2022 Ability to apply advanced and diverse engineering principles to the design and implementation of major system modifications, introduction of new processes, and capital projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n\u2022 Strong leadership, technical writing, and communication/presentation skills are required.\n\u2022 Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.\n\u2022 Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformances, corrective and preventative actions, and validation practices.\n\u2022 Experience in design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.\n\u2022 Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.", "date_new": "2011-11-01 22:17:12", "url": "http://www.amgen.jobs/xml/24526976/job", "country": "United States", "company": "Amgen", "title": "Sr Engineer - Process Equipment", "reqid": "12624BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 24526976}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 12441BR\nJob Posting Title Specialist IS Bus Sys Analyst\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Colorado\nLocation (City) Boulder\nAmgen Job Description The Center of Excellence (COE) Business and Application Support organization is responsible for supporting the business processes and application software being implemented through Amgen\u2019s ERP Program. Business Analysts within this team must possess thorough knowledge of the processes within their area of specialization as well as a comprehensive understanding of the configuration associated with the specific SAP components that are used to enable these processes.\n\nThe Specialist, IS Business System Analyst will be primarily responsible for providing business and application support of the production environment. The analysts will interact with members of the Client-Facing IS teams as well as with our Super Users and Business Partners. The analysts will also work directly with members of the COE\u2019s Technical and Infrastructure team to assist with the resolution of technical incidents as well as the implementation of new functionality.\n\nThe Business Systems Analyst will serve as a liaison between our Business Partners and the COE in the development of new application functionality. In this role, the Business Systems Analyst will be responsible for performing the analysis and design associated with new requirements. The Business Systems Analyst will collaborate with the Development organization to create functional and technical specifications and complete the necessary testing and documentation associated with these changes. The analyst will also work closely with the Computer System Validation group to ensure that all enhancements are implemented in a quality manner.\n\nLimited travel (5-10%) both within and outside the US is expected.\nBasic Qualifications -Doctorate degree\nOR\n-Master\u2019s degree & 3 years of directly related experience\nOR\n-Bachelor\u2019s degree & 5 years of directly related experience\nOR\n-Associate\u2019s degree & 10 years of directly related experience\nOR\n-High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications -2+ years experience operating within a validated systems environment (FDA, European Agency for the Evaluation of Medicinal Products, Ministry of Health, etc.).\n\n-2+ years of SAP project or production support team leadership role.\n\n-2+ years experience with storage and/or handling unit management.\n\n-2+ experience with IDOC interface.\n\n-Participation in 1 full ERP Implementation.\n\n-Basic knowledge of SAP\u2019s ABAP programming language.\n\n-Basic knowledge of Tier 2 systems (I.e. MES).\n\n-Knowledge in SAP organization design and integration with FICO, SD LE, IM/WM.\n\n-Experience using document repository and change management tools such as: Sharepoint, EDMQ, ISM, and Solution Manager.\n\n-SAP Certification in modules within MM, PP.\n\n-Excellent verbal, written and interpersonal communication skills.", "date_new": "2011-10-25 20:39:30", "url": "http://www.amgen.jobs/xml/24410997/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Bus Sys Analyst", "reqid": "12441BR", "state": "Colorado", "state_short": "CO", "location": "Boulder, CO", "uid": 24410997}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12252BR\nJob Posting Title Senior Manager Corporate IT Audit\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen seeks an IS - Sr. Manager, Corporate Audit for our Thousand Oaks, CA office. This individual will demonstrate a high level of professionalism and the ability to manage multiple projects simultaneously. Other duties include:\n\u2022 Execute Annual Audit Plan (SOX and Non-SOX) as approved by the Audit Committee\n\u2022 Provide leadership, guidance and coaching to audit staff in the execution of the Audit Plan and to achieve audit goals and objectives\n\u2022 Manage all internal reporting for the department, generating and supporting the development of standard and ad-hoc management reports\n\u2022 Support audit management in the preparation and development of executive presentations to the audit committee and executive management\n\u2022 Develop training programs for department including technical audit training, CPE certification, Six Sigma certification and professional career development\n\u2022 Assist directors, managers and staff of Amgen Corporate Audit, in providing independent, objective assurance and consulting services designed to add value and improve the operations of the Company\n\u2022 Participate in determining whether Corporate Audit\u2019s process and document management systems, control and governance processes are adequate and functioning in a manner appropriate to a Company of our size and market\n\u2022 Interact with Amgen senior and mid-level management\n\u2022 Exercise sound judgment and initiative in handling business issues of significance to Corporate Audit and the Company\n\u2022 Assist on special projects as needed\n\u2022 Discharges responsibilities in a manner that is consistent with The Institute of Internal Auditors\u2019 Code of Ethics, Standards for the Professional Practice of Internal Auditing and Statement of Responsibilities or Information Systems Audit and Control Association (ISACA).\n\u2022 Travel up to 25% per year\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Eight or more years of experience in finance, accounting or auditing\n\u2022 Eight or more years of experience in operations and project / change management\n\u2022 Four or more years of supervising staff or managing project teams\n\u2022 Bachelor's degree with an emphasis in accounting, finance, business administration, computer science, or in a life science related area\n\u2022 Advanced degrees / certifications such as CISA, CIA, CISSP, CISSM, CRISK, CGEIT, CPA and MBA is strongly preferred\n\u2022 External audit (e.g., Big Four) and /or internal audit (e.g., Fortune 500) experience is highly desirable\n\u2022 Working knowledge of enterprise applications such as ERP (SAP) systems, COSO framework and good audit experience of auditing ITIL, COBIT and other technical IS processes area a plus\n\u2022 Other desired experience in data management, data loss prevention, data security and classification\n\u2022 Self-starter with excellent project management and communication skills (both verbal and written), including the ability to effectively and confidentially interact with Amgen senior management\n\u2022 Excellent and insightful financial, analytical, interpersonal, team-building, leadership and conflict resolution skills\n\u2022 Proficient in Microsoft Word, Excel, and Power Point\n\u2022 Pharmaceutical / biotechnology industry experience is desirable", "date_new": "2011-09-29 09:13:12", "url": "http://www.amgen.jobs/xml/23915639/job", "country": "United States", "company": "Amgen", "title": "Senior Manager Corporate IT Audit", "reqid": "12252BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 23915639}, {"country_short": "USA", "city": "Boulder", "description": "Auto req 12161BR\nJob Posting Title Specialist IS Bus Sys Analyst (Warehouse Management and Serialization)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Colorado\nLocation (City) Boulder\nAmgen Job Description The Center of Excellence (COE) Business and Application Support organization is responsible for supporting the business processes and application software being implemented through Amgen\u2019s ERP Program. Business Analysts within this team must possess thorough knowledge of the processes within their area of specialization as well as a comprehensive understanding of the configuration associated with the specific SAP components that are used to enable these processes.\n\nThe Specialist, IS Business System Analyst will be primarily responsible for providing business and application support of the production environment. The analysts will interact with members of the Client-Facing IS teams as well as with our Super Users and Business Partners. The analysts will also work directly with members of the COE\u2019s Technical and Infrastructure team to assist with the resolution of technical incidents as well as the implementation of new functionality.\n\nThe Business Systems Analyst will serve as a liaison between our Business Partners and the COE in the development of new application functionality. In this role, the Business Systems Analyst will be responsible for performing the analysis and design associated with new requirements. The Business Systems Analyst will collaborate with the Development organization to create functional and technical specifications and complete the necessary testing and documentation associated with these changes. The analyst will also work closely with the Computer System Validation group to ensure that all enhancements are implemented in a quality manner.\n\nLimited travel (5-10%) both within and outside the US is expected.\nBasic Qualifications -Doctorate degree\nOR\n-Master\u2019s degree & 3 years of directly related experience\nOR\n-Bachelor\u2019s degree & 5 years of directly related experience\nOR\n-Associate\u2019s degree & 10 years of directly related experience\nOR\n-High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications -24x7 on-call support is necessary to resolve critical business & technical incidents.\n\n-5+ years experience in performing SAP configuration within the MM/Procurement/WM Modules, including experience with PP integration. The successful candidate will also possess a thorough understanding of the business processes enabled by these SAP components.\n\n-3+ years experience performing systems analysis, design and translating business requirements into functional and technical specifications.\n\n-2+ years experience operating within a validated systems environment (FDA, European Agency for the Evaluation of Medicinal Products, Ministry of Health, etc.).\n\n-1+ years experience implementing RF for warehouse transactions\n\n-1+ year of AII/OER experience.\n\n-2+ years of SAP project or production support team leadership role.\n\n-2+ years experience with storage and/or handling unit management.\n\n-2+ experience with IDOC interface.\n\n-Participation in 1 full ERP Implementation.\n\n-Basic knowledge of SAP\u2019s ABAP programming language.\n\n-Basic knowledge of Tier 2 systems (I.e. MES).\n\n-Experience using document repository and change management tools such as: Sharepoint, EDMQ, ISM, and Solution Manager.\n\n-SAP Certification in modules within WMS, MM, LE.\n\n-Excellent verbal, written and interpersonal communication skills.", "date_new": "2011-09-16 22:30:02", "url": "http://www.amgen.jobs/xml/23674745/job", "country": "United States", "company": "Amgen", "title": "Specialist IS Bus Sys Analyst (Warehouse Management and Serialization)", "reqid": "12161BR", "state": "Colorado", "state_short": "CO", "location": "Boulder, CO", "uid": 23674745}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 11636BR\nJob Posting Title Dir Information Systems\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Director Information Systems will act as the Operations Information Systems (OIS) leader supporting the Manufacturing of the Future initiative to include building of new manufacturing sites as well as modifications of existing facilities.\n\nResponsibilities Include:\n\u2022 Leading the application and evolution of Amgen Operations Information Systems S95 blueprint and technical architecture to the manufacturing of the Future facility requirements.\n\u2022 Accountability for delivering the OIS work streams in alignment with the larger program and Amgen IS organization.\n\u2022 Will form and manage strong relationships and work collaboratively with multiple areas across the enterprise to communicate, govern, and deliver the IS scope.\n\u2022 Providing technical & program/project leadership to the project teams in all project phases (design, delivery, startup, commissioning, validation and operational support) as well as IS project manager oversight to ensure the program/project budget, schedule and staffing is commensurate to enabling the manufacturing automation and information systems to attain the performance standards required to support the business objectives.\n\u2022 Influencing the development of business area strategy where appropriate.\n\u2022 Strong program / project management and leadership skills, including but not limited to the following: client interfacing and resolution of client concerns, developing and reporting project results, technical guidance of a project from concept to delivery, detailed project planning, vendor/contract management, system commissioning and validation, technical solution evaluation, schedule tracking.\nBasic Qualifications - Doctorate degree & 4 years of directly related experience\nOR\n- Master\u2019s degree & 8 years of directly related years\nOR\n- Bachelor\u2019s degree & 10 years of directly related experience\nAND\n- 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications - Demonstrated working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and will direct efforts of automation & Information Systems integrators, vendors, contractors, and Amgen teams in the successful execution of efforts by using appropriate development methodologies to establish a Process Automation System, Manufacturing Execution System, IT infrastructure, and Systems and Data Integration that meets Operations' business requirements.\n- Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation.\n- Direct experience with Shop floor Automation systems (DCS, PLC/SCADA, BAS), MES systems, Manufacturing IT infrastructure, and Plant Systems & data integration, and Information Management required. Experience with Emerson DeltaV, Rockwell PLC/SCADA/Batch, OSIsoft PI data historian, Werum PAS/X, MES and BMS is preferred. Experience in other areas of Information Systems supporting manufacturing business unit is a plus.\n- Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering.\n\n- ERP experience is a plus.", "date_new": "2011-09-15 19:42:22", "url": "http://www.amgen.jobs/xml/23645739/job", "country": "United States", "company": "Amgen", "title": "Dir Information Systems", "reqid": "11636BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 23645739}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 11901BR\nJob Posting Title Principal IS Architect - Data Architecture\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Providing easy access to accurate information is a key source of competitive advantage for Amgen. The Principal IS Architect - Data Architecture role will be responsible for identifying key challenges for easy data access, proposing a strategy for efficient data and information life-cycle management, and driving the execution of this data architecture strategy. This position will leverage existing project opportunities and/or initiating new efforts to make progress toward the target architecture and ensure the consistency of Amgen\u2019s data, business intelligence and application strategies.\n\nJob Responsibilities\n\n\u2022 KEY RESPONSIBILIITY: Perform data modeling, data governance, and data architecture design.\n\n\u2022 Conduct interviews with business leaders and users to identify information challenges and pain points.\n\u2022 Work with IS and business clients to establish a vision and a target state of enterprise data architecture to address the information challenges and pain points.\n\u2022 Analyze business requirements to assess data implications and develop data lifecycle and integration management strategies\n\u2022 Partner with business users, Client-facing IS teams, project teams, architects, and technical leads to deliver the required information capabilities and utilize information capabilities.\n\u2022 Facilitate data management and data governance for information stakeholders\n\u2022 Provide leadership to the discipline of data architecture and mentor junior staff in the field of data and information architecture\nBasic Qualifications -Doctorate degree & 2 years of directly related experience\nOR\n-Master\u2019s degree & 6 years of directly related experience\nOR\n-Bachelor\u2019s degree & 8 years of directly related experience\nOR\n-Associate\u2019s degree & 10 years of directly related experience\nOR\n-High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications -Bachelors degree in Engineering, Information Systems or Computer Science\n-10 years experience in Data Architecture and Governance, Information Management Strategy, and Master Data Management Strategy\n-5 year experience in enterprise-scale database application design/development or enterprise-scale database management operations\n-Demonstrated knowledge and experience in Enterprise Architecture strategy and information integration strategies.\n-Knowledge of life science business process and data desirable\n-Strong problem solving and interpersonal skills; consulting experience desired\n-Excellent written, oral communication and influencing skills\n-Ability to work both independently and as a team member with personnel at all levels in the organizational hierarchy.\n-Deep technical expertise in data management and data modeling\n-Demonstrated knowledge and experience delivering projects to meet business needs.", "date_new": "2011-08-24 20:15:19", "url": "http://www.amgen.jobs/xml/23225778/job", "country": "United States", "company": "Amgen", "title": "Principal IS Architect - Data Architecture", "reqid": "11901BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 23225778}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 11647BR\nJob Posting Title Specialist System Administrator - VDI XenDesktop\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nUnited States - Washington\nLocation (City) Seattle\nThousand Oaks\nAmgen Job Description This position can be located in Seattle, WA or Thousand Oaks, CA.\n\nThe primary responsibility of this position is to architect, setup and support a Virtual Desktop Infrastructure (VDI) for a large Enterprise. Candidate will be responsible to work with the desktop team to set up the images and applications needs based on changing business requirements. The Job responsibilities will also include evaluating new features and recommending the solutions to Management from time to time.\n\nResponsibilities will include management, oversight and direct support of specialized systems and applications.\n\nJob Responsibilities\n\n\u2022 Interface with customer, technology and business contacts to document customer challenges and requirements.\n\u2022 Provides Design, implement and optimize technology or process solutions to meet customer requirement for thin client computing.\n\u2022 Provides technical leadership for design and engineering engagements and for problem/performance issues resolution for all aspects associated with the VDI solution.\n\u2022 Responsible for ongoing management of VDI infrastructure.\n\u2022 Performs necessary systems maintenance in accordance with vendor best practices and Company change management policies.\n\u2022 Designs system migration architecture as required.\n\u2022 Responsible for runbook design, development, and ongoing updates.\n\u2022 Responsible for capacity planning and disaster recovery planning and design as applicable.\n\u2022 Provides ITIL process planning as applicable.\n\u2022 Recommend changes to procedures which result in operational optimization\n\u2022 Participate in Root Cause Analysis (RCA) reviews when applicable.\n\u2022 Rotational 24x7 On-Call Support\nBasic Qualifications \u2022 Doctorate degree\nOR\n\u2022 Master\u2019s degree & 3 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 5+ years as a Citrix/VDI/Virtualization Administrator\n\u2022 Experience in Design and implementation of Citrix XenDesktop Solution\n\u2022 Proven knowledge of virtualization technologies \u2013 VMWare, XenServer, HyperV\n\u2022 Proven understanding of XenApp, App-V or other like technologies\n\u2022 Experience in Citrix installation, application streaming, content redirection setup, ICA files creation, roaming profile management, and folder redirection.\n\u2022 Mid to senior level programming/scripting\n\u2022 Experience in installation and monitoring of Application Servers\n\u2022 Solid grasp of TCP/IP networking fundamentals.\n\u2022 Multiple years of experience in troubleshooting issues in a fast-paced high-availability production environments with an emphasis on remote \"lights-out\" management of systems.\n\u2022 Outstanding troubleshooting ability.\n\n\u2022 Certifications in related technologies\n\u2022 Experience with various MS based applications\n\u2022 Experience in Application Sequencing with App-v Remote location solutions with App-V Integration with Citrix Xendesktop / Xenapp\n\u2022 Experience Powershell scripting\n\u2022 Experience working in a regulated environment (Pharmaceutical industry)\n\u2022 Virtualization experience (VMware / Hyper-V/XenServer)\n\u2022 NetApp/SAN storage experience\n\u2022 Familiarity with SQL Databases or Messaging system solutions\n\u2022 Excellent data-driven problem solving and analytical skills\n\u2022 Experience leading large initiatives in multiple functional areas of a complex organization\n\u2022 Proven experience as part of a high performance team\n\nIdeal candidates should have experience in the life sciences area and is very comfortable with architecture, handling multiple projects and bringing a wealth of ideas on how to accomplish system management tasks for complex systems across multiple locations.", "date_new": "2011-08-12 22:18:34", "url": "http://www.amgen.jobs/xml/22999180/job", "country": "United States", "company": "Amgen", "title": "Specialist System Administrator - VDI XenDesktop", "reqid": "11647BR", "state": "California", "state_short": "CA", "location": "Seattle, CA", "uid": 22999180}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 11568BR\nJob Posting Title Associate Engineer - Drug Delivery Systems\nCareer Category Operations\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This position reports into the Drug Delivery Systems (DDS) group under Global Drug Product and Device Development in Thousand Oaks. This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of devices, diagnostics and ancillary items utilizing associated systems such as documentation, equipment and processes.\nBasic Qualifications \u2022 Bachelor\u2019s degree\nOR\n\u2022 Associate\u2019s degree & 4 years of directly related experience\nOR\n\u2022 High school diploma / GED & 6 years of directly related experience\nPreferred Qualifications BS degree in Mechanical Engineering, or other Engineering/Life Sciences\n3 years of experience in engineering specific to the device or biotech/pharmaceutical industry.\n3 years experience with device design, production and validation\nKnowledge of device development, manufacturing and test equipment, injection molding, and material science is important to the position.\nThe position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.\nIndependent thinker with demonstrated skills working in teams or leading project teams.", "date_new": "2011-07-29 19:29:32", "url": "http://www.amgen.jobs/xml/22717361/job", "country": "United States", "company": "Amgen", "title": "Associate Engineer - Drug Delivery Systems", "reqid": "11568BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 22717361}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 5103BR\nJob Posting Title Senior Manager of Technical Accounting\nCareer Category Finance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This key role in the Finance organization will work closely with Amgen's corporate development groups to provide accounting support related to licensing and other M&A transactions. The position will report to the Director, Technical Accounting and will also assist in providing thought leadership and current best practices surrounding technical accounting issues globally. Specifically, this role will:\n- Provide advice on the accounting treatment and structure related to all licensing and other M&A transactions\n- Ensure key stakeholders (including, but not limited to, the Chief Accounting Officer, leadership within Corporate External Reporting and Accounting Operations, and Amgen\u2019s independent auditors) are aware of contemplated deals and the potential impact to Amgen.\n- Collaborate with different business functions and teams to perform accounting due diligence on potential transactions\n- Ensure optimization for all contract provisions related to ongoing accounting obligations such as reporting, royalties, audits, etc.\n- Compile opening balance sheet purchase accounting entries including the sourcing and management of any related purchase accounting valuation activities\n- Document conclusions on executed transactions in technical accounting memos.\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications The ideal candidate should have strong knowledge and experience in the application of U.S. generally accepted accounting principles (GAAP) especially as it relates to accounting for acquisitions, partnerships and licensing transactions. He/She will have outstanding communication capabilities and must be comfortable and confident dealing with all levels of management within the organization.\n\n- 7 plus years of progressive accounting / finance experience including corporate level public company experience\n- CPA and 4 or more years of Big 4 audit firm experience required\n- Strong written, verbal communication, and presentation skills are required\n- Detail oriented; strong business analytical skills\n- Positive attitude and a strong work ethic\n- Ability to work in cross-functional team environment\n- A person of the highest personal integrity\n- Pharmaceutical/Biotech experience a plus\n- Knowledge and understanding of International Financial Reporting Standards (IFRS) a plus.\n- Knowledge of business valuation methods and M&A experience a plus\n\nPersonal Competencies\n\n- Integrity - Holds to well-articulated core values and expected behavior, and holds others to the same standard\n\n- Technical Knowledge - Deep knowledge of general accounting standards and the standards impacting areas critical to the Biopharmaceutical industry (manufacturing, research and development, revenue recognition, M&A, licensing, etc.).\n\n- Driving Results - Sets compelling goals and aggressive schedules for improvement while remaining flexible in a rapidly changing environment. Able to influence other functional areas in order to achieve results.\n\n- Communication - Is highly articulate; makes arguments, both written and oral, in a compelling and concise manner.", "date_new": "2011-06-25 18:26:38", "url": "http://www.amgen.jobs/xml/22025629/job", "country": "United States", "company": "Amgen", "title": "Senior Manager of Technical Accounting", "reqid": "5103BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 22025629}, {"country_short": "TUR", "city": "Istanbul", "description": "Auto req 9039BR\nJob Posting Title Market Access Manager\nCareer Category Government Affairs\nEmployee Subgroup Salaried FT\nCountry (State/Region) Turkey\nLocation (City) Istanbul\nAmgen Job Description Responsibilities:\n\u2022 Develops and implements Amgen\u2019s political engagement strategy with officials, regulatory agencies and key policymakers.\n\u2022 Directs projects and activities to create a favorable pharma environment\n\u2022 Monitors government initiatives/legislation, surveys impact on the organization and develops the organization's response to legislation\n\u2022 Represents the organization in front of key government officials and policymakers\n\u2022 Builds relationships with local authorities, regulatory agency heads and key policymakers\n\u2022 Enhances the organization's image among authorities\nBasic Qualifications University Degree\nMinimum 3 years of experience in industry\nMinimum 2 years of experience in a similar position\nFluency in English, both oral and written communications\nComputer skills (MS Office programs)\nPreferred Qualifications Minimum 2 years in a big pharmaceutical company", "date_new": "2011-04-01 23:13:07", "url": "http://www.amgen.jobs/xml/20488398/job", "country": "Turkey", "company": "Amgen", "title": "Market Access Manager", "reqid": "9039BR", "state": null, "state_short": null, "location": "Istanbul, TUR", "uid": 20488398}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 8552BR\nJob Posting Title Specialist Systems Administrator ( Backup Expert / Lead)\nCareer Category Information Systems\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nUnited States - Washington\nLocation (City) Seattle\nThousand Oaks\nAmgen Job Description This position can be located in Seattle, WA or Thousand Oaks, CA.\n\nThis senior backup administrator / architect position is part of the Storage & Backup team in Application Hosting Services within the Enterprise Services organization, and is responsible for supporting the enterprise backup environment for both NetBackup and NAS/SAN storage in a globally distributed environment.\n\nThis role requires demonstrated senior level architecture development/oversight and data lifecycle management expertise to help design a comprehensive data lifecycle management service. In addition, responsibilities include L3 support of critical backup operations involving thousands of servers in multiple locations in a global environment, assisting with the design and implementation of the next generation backup service and the company\u2019s data lifecycle management architecture and strategy, and serving as the SOX focal for the Data Protection Service.\n\nFunctions (duties/accountabilities) include the following:\n\nServes as a technical consultant in the area of IT Backup, Backup Compliance, Archive and Data Lifecycle Management.\nReviews and ensures Backup policies support the company Records and Retention policies, and aligned with Industry Best Practices.\nProvide direction for installation, configuration and support of backup and Disaster Recovery environments.\nTroubleshoot problems and provides rotational 24x7 on-call escalation for support of production backup systems.\nEnsure proper alerting for the backup environment, backup jobs, and data replication are in place.\nCreate and/or update documentation of Backup and Disaster Recovery environments and associated documented processes.\nInteract closely with management, engineers, application resources, Database Administrators, Windows and UNIX Administrators, and other architects to plan and support the environments and align with the backup group\u2019s overall strategy and direction.\nOversee backup provisioning, monitor systems, forecast future capacity demands, conduct performance tuning, system controls, and documentation; install, configure, upgrade and troubleshoot issues\n\nManage and keep Disaster Recovery environment in sync with primary on a specified periodic basis so in the event of disaster, operations can be restored in approved timeframes.\nAutomate backup processes with custom scripts, consolidate and upgrade systems.\nDesign a self-service backup architecture that incorporates data management lifecycle services.\nDevelop data life cycle management policies for the company.\nDefine and report metrics, Critical Success Factors (CSF\u2019s), and Key Performance Indicators (KPI\u2019s) for the processes.\nServe as the SOX focal in the area of backups for compliance purposes, and have a deep subject matter expertise regarding compliance in a regulated environment.\nCommunicate and manage expectations of the users during the planning and rollout of changes to the Incident management tools and/ or process.\nParticipate in regular incident review meetings to ensure incidents are being resolved promptly in order to minimize service outages.\nInteract and collaborate with site leads across the globe to develop / implement best practices for the backup and storage areas\nBasic Qualifications - Doctorate degree\nOR\n- Master\u2019s degree & 3 years of directly related experience\nOR\n- Bachelor\u2019s degree & 5 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications BS in Computer Science, Computer Information Systems or Computer Engineering\n\nTwo (2) or more certifications in the following areas: backup, SOX and/or DR vendor certifications (EMC, NetApp, HP, NetBackup, CSOX, etc.).\n\n5+ years or more as a backup lead engineer/architect (planning, designing, configuring and supporting large enterprise backup environments.\n\nExtensive domain knowledge and/or experience with Veritas NetBackup Administration, NetBackup Command Line, Quantum Tape Libraries, Bocada Enterprise Reporting, NetApp VTL devices, Data Domain De-Duplication Appliances, Quantum DXi, Iron Mountain Connected Backup (CDP), UNIX System Administration, Bare Metal Restores, BladeLogic and Systems Analysis/Design, Symantec eVault, NetApp SnapLock.\nStrong oral and written communication skills, excellent interpersonal skills, and the ability to interact well with multiple levels of management.\nStrong technical and analytical skills.\nAble to organize and schedule tasks, develop realistic action plans, and incorporate time constraints and task priorities.\nAbility to take initiative and work with minimum direction in a high demand environment.\nWorks effectively as a team member and leads cross-functional teams.\nDemonstrated ability to present designs, service direction, and scorecard results to executive management.\nAdvanced Microsoft Excel, Word, and PowerPoint skills aare highly preferred.", "date_new": "2011-03-07 22:11:23", "url": "http://www.amgen.jobs/xml/19982570/job", "country": "United States", "company": "Amgen", "title": "Specialist Systems Administrator ( Backup Expert / Lead)", "reqid": "8552BR", "state": "California", "state_short": "CA", "location": "Seattle, CA", "uid": 19982570}]