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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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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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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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The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$237,660 - $307,560 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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This role will partner with Clinical Affairs, Medical Affairs, Regulatory, Business Development, Product Development and other cross-functional teams to establish and execute short- and long-term GAVE strategic plans.
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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. Preferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise.
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This exciting and influential role will serve as Synopsys’ strategist and engagement lead for State and Local Government Affairs, including legislative, regulatory and policy objectives and ensure the integration and execution of these objectives to support the State and Local and broader Government Affairs strategy.
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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.
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Working with the product leads, the Sr. Manager CMC Regulatory Affairs provides strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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The Hoover Institution on War, Revolution, and Peace is a public policy research center devoted to the advanced study of economics, politics, history, and political economy—both domestic and foreign—as well as international affairs.
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We are looking for an Associate Director/Director, Regulatory Affairs CMC to join our team. Minimum 8-10+ years progressive Regulatory Affairs experience; 6+ years with an advanced science-related degree.
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Reporting to the Dean of Student Affairs and Activities at Foothill College, provides equity-minded and student-centered leadership for the student health services clinic. Reporting to the Dean of Student Affairs and Activities at Foothill College, provides equity-minded and student-centered leadership for the student health services clinic.
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Collaborate with clinical development and medical affairs to develop plans for publication of diagnostic test results in identifying biomarker-positive patient populations. Collaborate closely with diagnostic partners and internal functions, including biostatistics, data management, medical writing, regulatory, and project management to enable regulatory submissions to support CDx approvals.
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Engaging and collaborating with Local Markets, Global Strategic Marketing, Medical Affairs, Value and Access, Analytics and Insights, Competitive Intelligence, Commercial Operations, Pipeline Marketing, Clinical Development, Governmental Affairs and Public Affairs to develop and drive the implementation of the plan to support global HIV Franchise marketing strategy.
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affairs job Title: sr regulatory affairs Company: Thermo Fisher Scientific in Menlo Park, CA
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