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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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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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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes' biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others.
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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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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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Lead the establishment of best practices for continuous integration and continuous deployment, using technologies such as Jenkins, Travis, Docker, Kubernetes, Cloud services (AWS, Google Cloud)Lead the design and implementation of features and expansion of the case reporting tool and explore functionality to accommodate a broader array of diseases, such as cancer and rare conditions, based on FDA prioritization input.
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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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Complies with all CMS, USDA, FDA, DOH, OSHA regulations, and other local, state, and federal government regulations and codes as applicable. The Registered Dietitian Nutritionist will have the opportunity to impact seniors at this Maryland community through implementation of innovative dining and nutrition related programming.
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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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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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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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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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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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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
fda job in Silver Spring, MD
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