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Job Overview: A law firm in Washington, D.C., is seeking an FDA - Health Care Associate Attorney with 4-6 years of experience and a strong background in drug and medical device regulatory compliance issues, particularly in current good manufacturing practice (CGMP) matters.
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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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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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The Senior Specialist will, u nder 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.
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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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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.
$225,000 - $250,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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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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While prior knowledge is always a plus, we are happy to provide thorough training on OSHA (Occupational Safety and Health Administration), FDA (Food and Drug Administration), and FSMA (Food Safety Modernization Act) regulations.
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Demonstrated ability to gain understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, GCP, OHRP, IRB [NIH/NCRR for PCRC only.
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fda job in Hyattsville, MD
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