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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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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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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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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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Collaborates closely with the US HEOR group on biologics-related activities (providing input into early economic models/endpoints, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications), and presenting this back to the medical affairs teams.
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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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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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S/he will report to the Executive Director and is a key business partner for Hematology & Cell Therapy Medical Affairs. The Senior Director, Medical Performance and Outcomes (MPO) will support the MPO capability globally to drive the value of Hematology & Cell Therapy Medical Affairs.
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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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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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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$113,325 - $207,763 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Oversees the operation and maintenance of wastewater treatment plant and collection system to ensure compliance with regulatory procedures and reporting practices. Prepare reports as required by VEOLIA and all regulatory agencies.
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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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Provide Medical Affairs support and input into launch readiness activities including labeling, life cycle management, and other early commercialization initiatives for late-stage Oncology pipeline products.
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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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regulatory affairs jobs Title: sr affairs associate Company: Thermo Fisher Scientific in Plainsboro, NJ
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