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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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SPARC is seeking a Senior Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ. The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company.
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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 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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This role requires the functional understanding of Regulatory Affairs processes and the ability to perform database analysis, uploads and verification into the system to support the Global Regulatory Affairs function, as well as Integra LifeSciences.
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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Effectively partner with Medical Affairs, Regulatory Affairs, Marketing and other Commercial colleagues to ensure promotional labeling, advertisements and educational materials are reviewed in compliance with applicable laws and regulations in a timely fashion throughout the product life-cycle.
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Reporting to the Dean and Vice President of Academic Affairs, the Associate Academic Dean supports the Academic Dean in strategic planning initiatives, budgeting, and curricular matters; supervises the Center Directors; and assists the Dean with oversight of Field Education and the Library.
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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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Lead the launch planning process for APOC’s game-changing TBI test; define regulatory, market access, pricing, distribution, sales force organization and promotion strategies and develop sales forecasts.
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Strong command of the drug development process, regulatory environment, and legal and compliance regulations governing Medical Affairs activities is required. As a key member of the Global Medical Affairs (GMA) Leadership Team, the CMO contributes to the development and execution of the GMA Strategy, maximizing the value of Kyowa Kirin medicines for patients.
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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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Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for Client Global Regulatory Affairs.
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Collaborates with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA.ORGANIZATION STRUCTUREThe Director, Regulatory Affairs reports into the VP, Regulatory Affairs and is based in Pine Brook, New Jersey.
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A registered pharmacist who directs all activities of the Department of Pharmacy Services in accordance with administrative standards established by Princeton HealthCare System, the New Jersey State Board of Pharmacy, Federal and State Regulatory Agencies, JCAHO Standards, and ASHP practice guidelines.
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regulatory affairs jobs Title: sr director Company: Abbott Laboratories in Princeton, NJ
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