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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.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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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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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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.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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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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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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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In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK GRA in interactions with key regulatory agencies (FDA/ CBER.
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Knowledge of and experience supporting a Federal or military public health organization such as NIH, FDA, CDC or DHA. PhD in Human Resources, Industrial/Organizational Psychology, Organizational Development, or Management.
$95,776 - $162,819 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
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Experience within Federal Government, such as DHS, FDA, NIH, or HHS is highly preferred. As a Program Manager, you will be accountable for directing customer support services, engineering, program management/ Project Management Office (PMO) and strategic support activities across all aspects of the program, including Service Desk, Deskside/ White Glove Services, systems engineering, Low Code/ No Code, DevSecOps, Automation, Hybrid cloud infrastructure, and cybersecurity, engineering.
Full-timeExpandApply NowActive JobUpdated 8 days 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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The Registered Dietitian Nutritionist is a change agent within the Senior Living space for NEXDINE Hospitality. The Registered Dietitian Nutritionist helps plan, develop, organize, monitor and supervise the nutritional status of a resident/patient in accordance with the the current federal, state and local standard.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Requires a basic working knowledge of legal requirements and accreditation standards including The Joint Commission, Title XXII, Department of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), and United States Pharmacopeia (USP.
ExpandApply NowActive JobUpdated 3 days ago
fda job in Rockville, MD
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