[{"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": "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": "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": "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": "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": "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": "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}]