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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Importantly, the chosen candidate will manage and mentor a group of Regulatory Affairs strategists.
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The Senior Medical Writer is expected to develop and maintain a network of internal relationships with global and local cross-functional study teams, including personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.
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Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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In this capacity the Associate Director, Economic Modeling, will design and deliver rigorous economic modelling analytics that address business questions, and will champion best in class modeling methodology within Scientific Evidence & Policy Research (SEPR) at Scientific Affairs.
$135,000 - $232,300 a yearFull-timeExpandUpdated 1 month ago - UpvoteDownvoteShare Job
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Ensures alignment on access strategy and key account plans and initiatives by partnering internally with Value Communication and Contracting Strategy colleagues across all product categories, PCOR, Finance, CS&M, CMR, HEOR, Global, Field Sales, Account Management, Analytics, Investor Relations, Regulatory, and all others on a routine basis.
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Take part in technical teams for identified projects and products, which may include personnel from Engineering, Technology Transfer, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs.
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Work in close collaboration with colleagues in R&D Quality Management, operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA.
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1035 Public Affairs Specialist. 1084 Visual Information Specialist. 0301 User Experience Designer (Interactive Designer) 0301 Digital User Experience Researcher. 1035 Public Affairs Specialist.
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Executive Director, Research & Development (R&D) Quality Partner, Regulatory Affairs/Labeling. 15+ years R&D experience or relevant experience in RA, ideally with supporting clinical/regulatory/medical affairs, quality management, biomedical science, clinical development; equivalent experience.
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Offer user support and feedback on references and core claims library within the Medical/Legal/Regulatory review and approval system (Veeva Vault PromoMats) Maintain reference and claims library relevancy, working with Medical/Regulatory, conduct periodic audits of the information on file.
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ERM delivers a wide range of climate change services including decarbonization strategy development, creation of Scope 1, 2, and 3 carbon inventories, Task Force on Climate-related Financial Disclosure (TCFD) analysis and reporting, strategy development, policy and regulatory analysis, target setting, and benchmarking.
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regulatory affairs jobs Title: sr affairs associate in Lawrence, NJ
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