[{"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": "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}]