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A law firm is seeking a Senior FDA Drug/Biologics Regulation Counsel to join their team in Washington, DC. The ideal candidate will provide comprehensive legal counsel on FDA regulation matters pertaining to drugs, biologics, cellular, and gene therapy products.
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The Senior Specialist will, under limited supervision, provide a full range of contract and subcontract drafting, review, negotiation and administration services primarily with respect to government customer contracting (civilian agencies such as HHS, (CDC, CMS, NIH, HRSA, SAMHSA, FDA, etc.
$88,000 - $120,000 a yearRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Previous experience working and/or collaborating with researchers from federal government agencies whose mission relates to public health (e.g., NIH, CDC, FDA, HRSA, or other HHS agencies). ICA has established itself as a critical partner of the US Food and Drug Administration (FDA.
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Experience within healthcare domain (preferably FDA, NIH, or agencies in HHS) is highly preferred. Experience with IT Service Management, ServiceNow or ZenDesk, RPA (UIPath, Blue Prism, Automation Anywhere etc.
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Provide legal guidance and support on a wide range of regulatory and medical affairs matters, including but not limited to pre-market approvals, submissions and responses to the FDA, quality systems, commercialization, advertising, promotions, marketing, communications and labeling for on-label and off label products, new product introductions and revenue models, post-surveillance, inspections, deficiency/warning letters and/or recalls.
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Conducts all aspects of the donation process in compliance with established federal and state laws, OCME, AOPO and AATB standards, UNOS and FDA guidelines, CDC recommendations, AORN guidelines for aseptic technique and Infinite Legacy policies.
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Demonstrates expert understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, GCP, OHRP, IRB, NIH/NCRR.
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Certification demonstrates knowledge and skills of sterile processing practices in accordance with regulatory guidelines such as Food and Drug Administration (FDA) and the Joint Commission (JC.
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MATERIALS AND EQUIPMENT DIRECTLY USED •Standard equipment including: computer terminal, telephone, washer/decontaminator, sonic cleaner, sterilizer (steam and Sterrad), air compressor and biological incubator.
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IGS is currently recruiting for a remote Database Engineer to support our work with the Department of Health and Human Services (HHS), Food and Drug Administration (FDA). IGS is currently recruiting for a remote Database Engineer to support our work with the Department of Health and Human Services (HHS), Food and Drug Administration (FDA.
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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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Development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer. Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others.
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OSHA, EPA, FDA, USDA, HACCP, etc.) Our well-known banners include Albertsons, Safeway, Vons, Jewel-Osco, Shaw's, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen, Carrs, Kings Food Markets, and Balducci's Food Lovers Market.
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Experience working with a Federal Health agency such as NIH, CDC, CMS, FDA, VA, DHA, MHS or other health & human services organizations. Experience with one or more analytical systems, such as Python Anaconda, R Studio, Databricks, Palantir, Snowflake, Azure analytics, AWS analytics, or Google Cloud Platform (GCP) analytics.
$111,400 - $213,600 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Office of Testing and Research (OTR) conducts laboratory research on manufacturing, formulation, and characterization of drugs, and provides advice/consults, collaborative research opportunities, and scientific training to FDA staff on pharmaceutical quality, pharmaceutical equivalency, and bioavailability/bioequivalence issues including manufacturing, formulation, analytical testing, and modeling.
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fda job in Mclean, VA
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