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Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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Relationships This position reports directly to the Senior Director, Medical Affairs and will assist the Executive Director and Sr. Director (where applicable) in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. Key internal relationships include Field Medical Affairs, Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and Market Access.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Demonstrates change Agility through willingness to pivot current ways to working to new model(s)Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees.
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A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, etc. A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, etc.
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The molecular genomics Sr. Scientist role is responsible for developing molecular assays and generation of research use genomics data in support of BMS clinical trial analysis. This includes but is not limited to responsibility for genomics and gene expression profiling (GEP) biomarker assay technology/ platform selection, evaluation of in-house or vendor choice per assay use requirements, development, optimization, qualification/validation and/or execution of biomarker analysis for BMS translational medicine and clinical programs.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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Identify develop operational institutional pathways to grow scientific engagements research and data for the enterprise with a special focus on community oncology centers and accounts for ongoing working groups and consortium support Contributes to the scientific affairs HCE partnership execution with select external research partners to maximize effective and compliant delivery of research with external organizations.
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The Sr. Manager is to lead collaboration efforts with R&D IT to implement and maintain Eisai's global (Veeva) eTMF system. The base salary range for the Sr. Manager, eTMF System is from :114,600-150,500 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
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While the detailed responsibilities of this position are numerous and important, the overarching task is to ensure the smooth functioning of the department's Graduate student affairs and to assist the DGS in administering the resources needed for graduate student success.
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Experience with Medical Affairs activities including but not limited to, KOL engagement, clinical research, drug development, commercial planning and medical strategy. The Head of US Medical - Endocrine Medical Affairs will report to the US General Manager with primary responsibility to lead the US Medical Directors and ensure the compliant execution of all medical programs and functions associated with the late-stage development and medical aspects of commercialization of endocrine assets at Ascendis Pharma.
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Through our “Lifecycle Evidence Strategy”, “Clinical Trial Optimization”, “Medical Affairs” and “Real World Evidence” services, we deliver impact where it matters, from early drug development to commercialization.
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Familiarity with practices of and intersections between commercial sales, marketing, medical affairs, and market access organizations in the pharmaceutical industry. Working knowledge of relevant US pharmaceutical compliance guidelines, regulations (AKS, FCA, FDCA, HIPAA, FCPA) and PhRMA Code principles.
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As a visible RWE/D champion within the US organization, will interact with a wide number of NNI stakeholders across not only Clinical Data Science and Evidence (CDSE) but more broadly within Clinical, Medical and Regulatory, Market Access and Public Affairs, as well as collaborating where appropriate with therapeutically aligned global counterparts in Epidemiology, Data Science and Global Evidence and Pricing Access.
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affairs job Title: sr affairs Company: Thermo Fisher Scientific in Princeton, NJ
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