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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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Associate Director, Global Regulatory Affairs Operations, Authoring Support page is loaded. 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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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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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. 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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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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Reports to HCP Strategy Lead. Collaborates with cross-functional teams, including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, and other relevant NNI departments to ensure alignment of HCP brand objectives and strategies, effective execution of HCP experience strategies and transparent communications outside the department.
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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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The Director, Corporate Counsel – Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.
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Johnson & Johnson is currently seeking an Associate Director, Regulatory Advertising & Promotion to join our Health Care Compliance organization located in Titusville, NJ. At Johnson & Johnson,we believe health is everything.
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Develop and maintain strong business relationships with key functions responsible for value proposition enablement with a focus on clinical, commercial, regulatory, medical affairs, and HEOR stakeholders.
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The Princeton School of Public and International Affairs at Princeton University may have an occasional need for lecturers to teach or co-teach in areas such as International Relations, International Development, Domestic Policy, Global Health, Psychology and Public Policy and Economics and Public Policy during the 2024 - 2025 academic year.
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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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The Sr. Manager, Regulatory Affairs Compliance and Planning professional will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget.
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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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The *Internal Audit Control Manager *– Compliance Subject Matter expert is primarily accountable for ensuring adequate and appropriate audit coverage of federal/state/GSE requirements applicable to the organization by maintaining the compliance matrix and providing input to the audit plan and advice to audit teams regarding consumer compliance regulatory applicability.
$90,000 - $100,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: sr regulatory associate Company: Thermo Fisher Scientific in Princeton, NJ
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