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Ability to work effectively across functions, particularly when interfacing with clinical operations, statisticians, pharmacovigilance, and regulatory affairs. Board certified Oncologist with oncology clinical experience and drug development experience.
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The Vice President of Medical Affairs is responsible for providing clinical and scientific guidance in all areas of clinical risk, safety reviews, adverse experience reporting, product life cycle reviews, and protocol design.
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Collaborate with internal departments such as clinical development, regulatory affairs, and marketing to ensure cohesive messaging and strategic alignment. Experience in medical affairs or medical communications.
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The Director will also ensure effective communication and collaboration between Specialty Pharmacy, Patient Services, Sales, Medical Affairs, and Marketing. The Director will also ensure effective communication and collaboration between Specialty Pharmacy, Patient Services, Sales, Medical Affairs, and Marketing.
$265,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
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Work closely with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to ensure alignment of stability studies. Oversee the design and execution of stability studies including protocol development, sample management, and data collection.
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The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
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Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications. Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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Preferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise. This contractor role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) Medical Affairs organization and reports to the Executive Director of Global Medical Affairs, Hepatitis C. This is a global role that involves the development and execution of global strategies for products in the LIFE franchise.
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Global Medical Affairs Plan of Action, publications, reviews of medical and commercial assets, etc.) As part of the global liver diseases medical affairs group, there will also be an opportunity to work closely with Hepatitis B.
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The Vice President, Regulatory Affairs and Quality Assurance, will lead the regulatory and quality functions for all development-stage programs. Terns Pharmaceuticals, Inc. (NASDAQ: TERN) is a clinical-stage biopharmaceutical company developing a portfolio of small molecule product candidates to address serious diseases, including oncology and obesity.
$325,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop and drive meaningful public affairs campaigns that support Snap’s business goals. The Company’s three core products are , a visual messaging app that enhances your relationships with friends, family, and the world; , an augmented reality platform that powers AR across Snapchat and other services; and its AR glasses.
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Management of personal affairs, including travel arrangements, personal shopping, and lifestyle management. Management of personal affairs, including travel arrangements, personal shopping, and lifestyle management.
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They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small molecule (drug)-imaging agents. Provide overall leadership of the regulatory function, interfacing with the Clinical, Quality Assurance and CMC teams.
$300,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Effectively communicate ideas, project goals, and results to team members across functions and departments, including device development, packaging, quality, regulatory affairs and manufacturing.
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affairs job in Redwood City, CA
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