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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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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Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications. Innova Solutions is immediately hiring Associate Manager - Medical Affairs.
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Bachelors required, preference to a MD, PharmD, or PhD graduate with experience in medical affairs and a background in virology/clinical virology, hepatology, or infectious disease. This contractor role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) Medical Affairs organization.
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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 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 6 days ago - UpvoteDownvoteShare Job
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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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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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Other activities, as assigned, to support LIFE Medical Affairs. Associate Manager - Medical Affairs. Oversee medical and scientific review of promotional materials for GRC and MRC. Bachelor's degree a minimum, but M.D., D.O., PhD (biological or pharmaceutical sciences), or PharmD preferred.
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This position sits in the Real World Evidence (RWE) team within Medical Affairs and reports into the Head of RWE. This role requires a hybrid skill set between clinical research, clinical data management, working with healthcare providers, and understanding the oncology space.
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A scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
$237,660 - $307,560 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Must be fully Client 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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Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities.
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affairs job Title: regulatory affairs specialist Company: Parexel in San Mateo, CA
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