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Strong knowledge of regulatory guidelines (e.g., ICH-GCP, FDA, EMA) pertaining to TMF. Implement and maintain TMF quality control processes that are aligned to internal standards, regulatory requirements, and GCP.
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The Program Leader will lead a cross-functional matrix team consisting of functional representatives from clinical development, clinical operations, regulatory affairs, translational medicine, clinical pharmacology, clinical biomarkers, CMC, non-clinical sciences, and medical affairs to deliver against an ambitious program strategy.
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Reporting to: Sr. Director, Medical AffairsLocation: United States, Boston, MAJob SummaryThe Medical Information Scientist, Medical Affairs will be accountable for Medical Information systems, processes, operations, and deliverables for Orchard’s investigational and approved hematopoietic stem cell - gene therapy (HSC-GT) clinical programs.
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Professional certification such as a Certified Regulatory Compliance Manager (CRCM), Certified Public Accountant (CPA), Certified Anti-Money Laundering Specialist (CAMS), or other compliance-related certifications.
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Enforce the rules of the university by working in partnership with the Dean of Student Affairs Office and provide written and oral documentation of violations. The Tufts University Department of Public Safety is comprised of fully sworn and certified police officers, campus security officers, dispatchers, emergency management, fire safety, crisis intervention, threat assessment staff and a student run EMS service.
$28.77 - $32.67 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Counsel key stakeholders on legal, regulatory and policy developments such as Inflation Reduction Act, fraud and abuse, privacy, government price reporting and antitrust. Assist with a broad range of other healthcare regulatory matters including funding requests and client and vendor training.
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Investor Services compromises of Compliance Services (investor AML/KYC, sanctions screening and related regulatory services) and Investor Relations. Keep abreast of industry and regulatory changes, identify impact to and opportunities for Investor Services.
$190,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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Serving as a chief operating officer for External Affairs, they provide strategic planning and direction to senior leaders and department heads in creating and establishing annual budgets for Marketing & Communications, Government & Community Affairs, and Federal Relations to ensure sound and effective fiscal resource management.
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Ph. D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 2 years biopharmaceutical industry experience as a biostatistician or a Master’s degree in a relevant statistics field and 4 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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As part of the legal team, the Associate General Counsel will be called upon to offer legal advice and strategy on a wide variety of matters throughout the agency pertaining to the regulatory oversight of casino gaming, sports wagering, horse racing, and other matters under the Commission's purview.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
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Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Support any regulatory inspections or internal/external audits. pH Meter, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Infrared (IR), Gamma Ray Spectrometer, Flame Atomic Absorption (AA), Scanning Ultraviolet/Visible (UV/VIS) Spectrometer, Polarograph, Coulometer, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Cambridge, MA
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