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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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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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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.
$310,000 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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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 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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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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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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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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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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Detect and identify the pathogens mentioned above in the various environmental samples listed above using culture techniques specific to each pathogen as per the FDA BAM or other validated methods.
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Lead development of Amneal’s position respect to FDA, CMS, Congressional, and state policy proposals reflected in proposed legislation, regulations, guidances, and other policy statements through solicitation from Amneal subject-matter experts and leadership, comment drafting, and advocacy on policies impacting R&D, commercial, finance, and legal work functions in Generics, Specialty, and Biosimilars.
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The AGC's areas of primary responsibilities include:Marketing, Labeling and Advertising: Provide legal advice and risk management counseling on a variety of legal issues, including label claims, packaging, FDA and FTC compliance; review media and advertising for legal compliance and risk management.
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