Amgen Jobshttp://www.amgen.jobs2012-05-26 14:59:17.573457GBRCambridgeAuto req 15797BR Job Posting Title Associate Finance Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Field Based Uxbridge Amgen 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. Basic Qualifications Associate’s degree & 4 years of experience directly related to the job OR High school diploma / GED & 6 years of experience directly related to the job Preferred Qualifications • Strong communication skills • Excellent organizational skills and detail oriented • Ability to use Microsoft Word, Excel, and Power Point • Able to multi-task and stay focused on priorities in a fast paced environment to meet deadlines • Strong team player who is able to collaborate with colleagues on complex tasks • Prior work experience a plus • Biotechnology, pharmaceutical or healthcare industry experience is a plus but not required2012-05-23 18:45:28United KingdomAmgenNone15797BRNoneCambridge, GBR28892002http://www.amgen.jobs/xml/28892002/jobGBRCambridgeAuto req 15726BR Job Posting Title Regulatory Affairs Director - Biosimilars Policy Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description Overview: The 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 Responsibilities: • Develop, direct and deliver strategic regulatory plans that are in-line with regulatory and business needs • Develop innovative solutions to complex problems through in-depth analysis, coordination and negotiation with subject-matter experts and key decision makers • Work in partnership with cross-functional teams and Amgen leadership to develop regulatory plans that support the direction of the business • Advocate to a broad spectrum of internal and external stakeholders the adoption of policies for achieving regulatory and business goals • Develop mutually beneficial strategic alliances with internal and external subject-matter experts and external key decision makers • Engage in direct advocacy with national, regional and global policy makers and regulators • Represent Amgen and the innovator industry in policy testimony and on trade association key issue team • May have direct reports, but spends more than 50% of their time working as a individual contributor Key Relationships: • Internal cross-functional project teams (national, regional and global) • Amgen leadership teams • Internal subject-matter experts and external key decision makers • Government and Regulatory Agency officials Basic Qualifications • University degree with significant directly related experience Preferred Qualifications • Science-background (eg. BSc, PhD, MD) • Experience in regulatory or clinical development, ideally with biologics • Understanding of national and global healthcare system, including payers • Critical thinker, able to analyze and critique data • Intellectually creative, able to assess a situation from multiple perspectives • Skilled and credible advocate with experience in 1:1 engagement, large audiences, panel debates • Able to form and defend a position under challenge2012-05-18 18:07:00United KingdomAmgenNone15726BRNoneCambridge, GBR28792889http://www.amgen.jobs/xml/28792889/jobGBRCambridgeAuto req 13698BR Job Posting Title Regulatory Affairs Sr Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description Overview: The Regulatory Affairs Senior Manager is responsible for leading regulatory aspects of a product’s development, blending strategic and project delivery; team management and providing subject matter expertise globally. The emerging markets team is responsible for development and implementation of regional regulatory strategies to expedite global development and registration. This includes:- • Interfacing with the Amgen Regional Hubs for specific strategies or activities that impact a specific region. • Managing the execution of regional strategies and regulatory communications and submissions. • Providing expertise on regional regulatory requirements and precedence to interdepartmental teams. Responsibilities: • Lead the international regulatory aspects of a product’s development. • Be responsible for the regional strategy and execution of the preparation of MA and life cycle submissions. • 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. • Ensuring global and regional strategy can be implemented within constraints of local requirements through coordination of LOC expertise. • Assist GDT to develop study protocols reports and development plans aimed at achieving regulatory approval and product labelling that supports key messages. • Develop proactive relationship with these regulatory authorities. • 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 • Troubleshoot and resolve any problems on the critical path to regional registration in concert with global registration strategy. Basic Qualifications • Relevant Bachelor’s degree is essential • In depth practical experience of the drug development process, from early phase to approval, as well as post-marketing experience. • Experience of managing a centralised procedure for regulatory submission. • Scientific expertise and acumen to work with colleagues across disciplines leading the regulatory agency submission process • Direct line management experience • Experience of liaising with relevant regulatory authorities for scientific advice. Preferred Qualifications • Experience gained within a biologics organisation • Second degree or further education/qualifications • Project management expertise2012-05-10 18:48:28United KingdomAmgenNone13698BRNoneCambridge, GBR28605646http://www.amgen.jobs/xml/28605646/jobGBRCambridgeAuto req 15496BR Job Posting Title Regional Account Manager - Oncology - East & West Midlands Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United Kingdom Location (City) Cambridge Field Based Uxbridge Amgen Job Description Purpose: Diagnosing 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. Plans, organises and executes activities to ensure access to funding and sales of our products to meet regional and national goals. Basic Qualifications Accountabilities: Conducts 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. Conducts an analysis of brand strategies to ensure account plans are aligned and prioritised. Profiles and validates key customers. Inputs into the prioritisation of customers to refine segmentation plan. Works effectively with market research and HE team to assess market opportunity. Produces a plan of action to ensure achievement of account priorities and regional and national brand strategy. Involves key internal stakeholders in preparation of account plans to ensure alignment and prioritisation of activities. Supports identification of opinion leaders and develops engagement plan Ensures all activities agreed within the account plans are implemented to completion within time, cost, compliance and quality constraints. Managed Entry – work with payers prior to the launch of new products to ensure an optimum environment. Translates national plan to develop regional plan of action. Develops metrics for success and tracks progress relative to targets. Market Access – ensure an optimum environment for the prescribing of Amgen products both current and future Service Development/Implementation – 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 Maintains effective collaboration within own and cross-functional teams to ensure alignment, progress updates and knowledge share. All role activities completed to meet team/Amgen standard operating procedures and quality standards. Completes all administration and reporting requirements, e.g. CRM, and ensure compliance with Amgen record retention policy. Preferred Qualifications Preferred Qualifications Essential - Extensive experience of working the wider health economy ie, PCT’s, SHA and Cancer Networks in order to make funding available for both new and in line products. - Proven hospital only sales experience - A proven track record of consistently high performance in a hospital sales environment - Experience of working in a primary care (PCO) environment2012-05-01 18:58:34United KingdomAmgenNone15496BRNoneCambridge, GBR28303386http://www.amgen.jobs/xml/28303386/jobGBRCambridgeAuto req 14537BR Job Posting Title Regulatory Affairs Senior Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description The purpose of this role is: •To 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 •To ensure regulatory compliance, with a focus on patient safety •As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade) This role is responsible for: •Advising the GRT on regional considerations in developing strategy •Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders • May manage one or more regional leads or support roles Key Activities: 1.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. 2.Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements. 3.Leads development of regional regulatory documents and meetings in accordance with GRT strategy 4.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) 5.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. 6.Manages regional label negotiation activities 7.With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning 8.Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives 9.Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs) 10.Communicates regulatory strategies as appropriate such that expectations are understood. 11.Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management 12.Develop predictions for expectations and risks associated with outcomes by regulatory agencies 13.Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments) Knowledge & Skills: 1.Regulatory knowledge in national regulations 2.Working with policies, procedures and SOP’s 3.Experience with national legislation and regulations relating to medicinal products 4.Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals. 5.Understanding of drug development Basic Qualifications - Doctorate degree and 2 years of directly related experience OR - Master’s degree and 6 years of directly related experience OR - Bachelor’s degree and 8 years of directly related experience OR - Associate’s degree and 10 years of directly related experience OR - High school diploma / GED and 12 years of directly related experience Preferred Qualifications • Experience gained within a biologics organisation • Second degree or further education/qualifications • Project management Expertise2012-04-26 18:18:54United KingdomAmgenNone14537BRNoneCambridge, GBR28203603http://www.amgen.jobs/xml/28203603/jobGBRCambridgeAuto req 13694BR Job Posting Title Sr Associate IS Bus Sys Analyst Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Uxbridge Amgen Job Description Overview: The 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. Key Responsibilities: • Provide technical 2nd and 3rd line support for Amgen Business Applications • Provide co-ordination of major incidents relating to Safety applications support where required • 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 • 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 • Provide operational direction and support for Global Safety Adverse Event intake channels (fax, e-mail, telephone etc.) across all global Amgen affiliates • 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 • 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 • 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 Basic Qualifications • Degree qualified in an IS related discipline or equivalent • Substantial relevant knowledge and experience gained in an IS environment Preferred Qualifications Knowledge: • Intimate knowledge and experience of Drug Safety systems and supporting business processes • Experience of analysing business requirements related to E2B and Reporting Rules • Data interfaces/file transfer, reporting and analysis skills • Documentation management • Knowledge of Unified Modeling Language • Network, infrastructure, operating system & web technology fundamentals • Software development lifecycle • Database & SQL fundamentals • Technical diagram/process flow charting • Entity relationships, use cases, design and concepts • Change control techniques • MS Office & MS Project fundamentals2012-02-24 19:33:07United KingdomAmgenNone13694BRNoneCambridge, GBR26739982http://www.amgen.jobs/xml/26739982/jobGBRCambridgeAuto req 13453BR Job Posting Title Medical Development Sr Mgr Career Category Medical Affairs Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Cambridge Amgen Job Description Overview: The 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 . Key responsibilities • Set UK/Ireland goals and dashboards to evaluate performance, approving TA plans, goals, proposals and deliverables • Be the single point of accountability for all UK/Ireland TA activities ensuring alignment of early-stage strategy with late-stage TA objectives • Drive the data generation, establishing and communicating the strategy for the UK/Ireland TA • 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. • 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 • Assist UK/Ireland Medical Advisors in interactions and communication with external customers, key organizations, and institutions • Assess risk and identifying issues, conflicts or gaps (Affiliate/Sub-Regional) across the portfolio • Perform portfolio level risk assessments and prioritization of programs • Chair Affiliate/Sub-Regional TA Team meeting and the Local Development Team (LDT) • Serve as a key interface to communicate Internationally and locally important issues and status of programs to Amgen IRD and UK/Ireland Management • Foster and improve International collaboration and coordination • Partner with the UK/Ireland Business Unit for all product lifecycle management activities • Provide input, review, approve the UK/Ireland lifecycle management plan and ensure alignment across the portfolio • Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio • Provide clinical oversight of product safety evaluation within the Affiliate/Sub-Regional TA • Provide support and leadership for advisory boards Basic Qualifications • Medical Degree (MD) • 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 • Substantial experience gained in a pharmaceutical or biotechnology company • Broad and formal leadership experience Preferred Qualifications • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale • In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials • Medical knowledge in the relevant therapeutic area • Sound scientific and clinical judgment • Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups • Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements • Understanding of new drug commercialization and business practices • Understanding of resourcing and budgeting • Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication • Demonstrated ability to organize and lead expert Medical Advisory Panels • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues • Track record in effectively managing risk and compliance • Building strong relationships with KOLs within DA • Coaching and mentoring Medical Advisor within a Medical Department • Extensive experience working in cross-functional teams Competencies: • Decision Making • Leadership (Scientific, Technical and Departmental) • Problem Solving • Written and Oral Communication • Innovation • Initiative • Delivery Focus • Conflict management • KOL engagement2012-02-01 02:26:20United KingdomAmgenNone13453BRNoneCambridge, GBR26231372http://www.amgen.jobs/xml/26231372/job