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Coordinates with investigators and study team members to ensure stipulations from approving bodies (Scientific Review Committee, FDA, Institutional Review Board (IRB) and Radiation Safety Committee (RSC.
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Familiarity with FDA regulatory requirements for IND and IDE; preferably those related to investigational biologic agents regulated by the FDA, and guidelines for facilitating clinical human subjects research.
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One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial.
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A research opportunity is currently available in the Office of Biostatistics and Pharmacovigilance (OBPV) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
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Opportunities are available in our Boston, New York, Palo Alto, San Diego, San Francisco, Washington D.C., and Los Angeles offices.
$310,000 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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4-6 years of experience in FDA regulatory compliance, preferably in a law firm or corporate setting. Duties:Provide legal advice and support on FDA regulatory matters related to drug and medical device compliance.
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Familiarity with FDA regulatory process. Work with FDA stakeholders to review background packages and mock safety datasets to assess appropriateness of controlled terminology and safety dataset structure.
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Develops and maintains effective relationships internally, such as with top level FDA and HHS officials; and externally, with Members of Congress, counterparts in other agencies, foreign health officials, academia, consumer groups and others to communicate on chemical safety issues, coordinate policy development, and exchange critical scientific information.
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Opportunities are available in our Boston, New York, Palo Alto, San Diego, San Francisco, Washington D.C., and Los Angeles offices.
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FDA Emerging Pathogens Preparedness Program: After a regulatory science workshop with officials from the FDA, NIH, and the Department of Defense, proposed a program for the FDA’s Center for Biologics Evaluation and Research which was included in the 2024 President’s budget and was accepted into the Senate’s Pandemic All Hazards Preparedness Act legislation.
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The Senior Clinical Research Coordinator independently develops and implements research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and sponsor regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA.
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The Quality Assurance Auditor, Research Compliance Specialist works in the Office of Research Quality Assurance (ORQA), an office within the office of Human Subjects Protections (OHSP), will support the Senior Director of the OHSP by conducting internal routine audits of clinical investigations at Lombardi Comprehensive Cancer Center (LCCC) to ensure compliance with University, FDA, Office of Human Research Protections (OHRP), Good Clinical Practice (GCP), state and federal guidelines.
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Drafting policy recommendations/policy statements/white papers for policy makers on Capitol Hill and within federal agencies, most specifically in regard to the NIH and FDA on particularly important science policy-related topics, such as e-cigarettes, the “common rule” for human subject protection regulations, the precision medicine initiative, cancer health disparities, among other possible topics.
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Advises on matters including FDA, HSRP, ACU/OLA compliance, biosafety, privacy and information security, sponsored research, and programs. On behalf of the General Counsel, serve as liaison to the Chief Academic Officer and Chair of Pediatrics, the Chief Innovation Officer, and the Chief Information Officer.
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The exposure is second to none; litigating both criminal and civil cases at the trial and appellate level, as well as defending individuals and companies in prosecutions and investigations conducted by U.S. Attorneys’ Offices and multiple divisions of the U.S. Department of Justice (DOJ), including, Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Securities and Exchange Commission (SEC) and Antitrust Division.
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fda job in College Park, MD
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