Amgen Jobshttp://www.amgen.jobs2012-05-26 15:05:20.322451CHEZugAuto req 15674BR Job Posting Title Senior Associate Clinical Operations Management Career Category Clinical Employee Subgroup Invoice Paid FT Country (State/Region) Switzerland Location (City) Zug Amgen 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: Contribute to the design and preparation of the draft informed consent template, ensuring Local content is added Assist in the conduct of feasibility assessments for new clinical protocols if required Contribute to the identification and selection of clinical investigators Work with the Clinical Operations Managers (COM’s) and Senior Associate Clinical Operations Management (SACOMs) colleagues to formulate a comprehensive recruitment plan for each new project. Contribute to the development of study specific processes including study communication plans Participate in identifying study related issues, and work with the COM and MCFO to initiate corrective actions when necessary With the study-specific COM, plan and conduct monthly project review meetings in order to update all Managers on study progress, issues and planned resolutions. Participate in local team meetings, task forces and liaise with Global Study Team if required Identifying and reviewing process issues within the clinical development group and recommending improvements when required Accompany CRA in site evaluations, initiations, monitoring and close out if required. Act as back up to COMs when required Coordinate & actively participate at local investigators meetings Review CQA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs) For studies with sole project management responsibility (eg Phase 4, follow up and extension studies) Basic Qualifications BA/BS/BSc or qualified nurse (RN) Work 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) Preferred Qualifications Project management experience in life sciences or medically related field obtained working on clinical trials in a biotech, pharmaceutical or CRO company Operational performance measurement experience International collaboration experience2012-05-09 20:33:38SwitzerlandAmgenNone15674BRNoneZug, CHE28581226http://www.amgen.jobs/xml/28581226/jobCHEZug - HQAuto req 13040BR Job Posting Title Regional Access Lead Career Category Government Affairs Employee Subgroup Salaried FT Country (State/Region) Switzerland Location (City) Zug - HQ Amgen 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” product strategy into specific operational tactics that are most effective at a country-specific level. Internal Accountabilities • Partner with Executive Director, ICO EM Europe, to understand strategic business imperatives and access objectives • Foster collaboration with cross-functional partners as well as PALs and Affiliate V&A Leads in support of access in EM Europe • Ensure close partnership with IHE Lead in EM Europe to align strategy and evidence generation to support value proposition • Ensure close partnership with International Governmental Affairs Lead in EM Europe to develop optimal approach with governmental payers • Ensure close partnership with International Pricing and Contracting Lead in EM Europe to align pricing and contracting strategies with overall access plans Accountabilities for External-Facing Activities • 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 • 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. • 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 • 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) • 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) • Drive development and implementation of access strategies within EM Europe across the portfolio • Coordinate access training and best-practice sharing across EM Europe, especially among affiliates that share similar pricing and reimbursement structures Deliverables • Emerging Europe Payer Situational Analysis: annual snapshot of reimbursement planning assumptions including identification of evolving trends • 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: • Emerging Markets Europe sections of ICO Product Value and Access Plans (Collaborate with PALs) and Global Payer Plans (Collaborate with GPLs) • 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) • Achievement of access plan: price at or above target, timely reimbursement when deemed desirable for appropriate target population Basic Qualifications • Higher education (University degree) and an MBA is highly valued • At least 2-3 years of experience in a similar position • 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 • Strong leadership skills with demonstrated ability to lead cross-functional teams and engage in productive debate and collaboration with senior leaders across the organization • Excellent communication skills, including interpersonal skills to foster collaboration and succeed in a highly matrixed environment • Strong oral/written presentation skills • Strong strategic planning skills—both at the product level as well as at the country (cross-portfolio) level • Ability to conduct situation analysis of external pricing and reimbursement environment and to synthesize relevant information to support development of country-specific strategic plans • Ability to identify the most compelling way in which to demonstrate and communicate product value to payers • Capability to interact with external stakeholders at multiple levels and to influence course of action through value communication, policy arguments, and negotiation Preferred Qualifications • Customer and HTA agency engagement • Direct payer experience and/or experience in product commercialization desirable • Regional or global experience strongly preferred • Strategic planning and health policy experience strongly preferred • Strong understanding of strategic pricing and contracting, including innovative approaches such as risk-sharing deals • 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 payers2011-12-16 19:10:56SwitzerlandAmgenNone13040BRNoneZug - HQ, CHE25420880http://www.amgen.jobs/xml/25420880/job