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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 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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Currently I have an opening for an Associate Manager, Global Medical Affairs located in location. 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. 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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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Associate Director, Analytical Development, Raw Materials. Extensive hands-on experience in a wide range of analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
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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. This is a global role that involves the development and execution of global strategies for products in the LIFE franchise.
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These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Knowledge of state & federal OSHA, US Coast Guard regulations, PSMSC and other safety regulatory requirements for the maritime industry. The Company serves as stevedore and/or terminal operator for a wide variety of maritime cargoes for export and import.
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Experience advising clients on global policy matters, new legislative and regulatory developments, and legal and policy advocacy options and strategies. You will report to Verkada’s Deputy General Counsel and Chief Privacy Officer and play a significant role in shaping the direction of the privacy and AI programs.
$215,000 - $325,000 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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We are looking for a Forensic Technologist to join our eDiscovery and Information Governance Legal Team. In your role as a Forensic Technology Lead, you will focus on discovery/disclosure efforts in the various phases of the EDRM model for litigation and regulatory matters, investigations, and all other matters requiring the identification, preservation, collection, processing, and production of data.
$104,000 - $146,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A Day in the LifeAppLovin seeks an intellectually curious, strategic, and highly motivated attorney to join the growing Privacy, Litigation, and Regulatory (PLR) team within AppLovin Legal, reporting to the Senior Managing Litigation & Regulatory Counsel.
$152,000 - $247,000Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Collaborate closely with other departments, including Formulation and Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure seamless integration of packaging processes with overall drug product manufacturing and distribution operations.
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The Senior Research Scientist I will be responsible for lead optimization, API form selection/characterization, pre-formulation, formulation development, manufacture of clinical supplies, development of efficient and scalable manufacturing processes, process scale up based on Quality by Design (QbD), implementation of innovative technologies, CMO management and global regulatory strategy.
$177,905 - $230,230 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Collaborating closely with cross-functional teams, the Senior Scientist will play an integral part in guaranteeing the quality, safety, and adherence to regulatory standards of our products. Excellent technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents.
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Requires Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Industrial Engineering Management, Regulatory Affairs, Regulatory Science, or related field and 7 years of progressive post-baccalaureate experience as a quality engineer, validation engineer or any quality assurance occupation in medical device or regulated industry.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in San Carlos, CA
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