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Oversees the return, disposal and/or destruction of unused supplies per Sponsor requirements; reconciles test article accountability; documents research participants who are lost to follow-up or who withdraw consent; assists in the preparation for a potential routine pre-market approval (PMA) FDA inspection as applicable.
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ASRC Federal has a large Health IT and Services portfolio that includes DHA, CMS, NIH, FDA and other agencies. We are looking for Subject Matter Experts and Policy/Research Analysts in the following areas: Medical Preparedness PolicyPublic HealthPortfolio ManagementOperational MedicineGlobal Health EngagementMedical Counter MeasuresDefense Medical LogisticsDefense Medical Research and Regulatory OversightPsychological Health and Readiness Get to Know ASRC Federal: We are a wholly owned subsidiary of Arctic Slope Regional Corporation, an Alaska Native Corporation, inspired by the Inupiat culture.
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Maintains a thorough understanding of state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance.
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Strong understanding of the architecture, requirements and partners within the healthcare ecosystem, especially in system integration/modernization and cloud-based analytics solutions at CMS, FDA, CDC and/or NIH.
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Leverages key relationships, internally and externally (e.g. FDA, EMA and national competent authorities, industry associations) to advance Amgen's position related to regulatory and safety policy.
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If you are serving, or have served in the last 5 years (from 04/17/2024) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.
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Abundant collaborative opportunities exist both within the College of Medicine and with nearby universities and institutions (NIH, FDA, USDA, Smithsonian) across the greater Washington, D.C. area.
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In this role, you will provide support for litigation, legislative, and regulatory activities, including legal research and policy analysis related to FDA regulation and the defense of state and local tobacco control laws.
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Maintain and organize records of protocol versions, FDA and IRB submission dates, and FDA & IRB approval dates. Experience with FDA processes. Master's degree in public health or healthcare, biomedical science, or regulatory field.
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Ensures that vehicle manifests, vehicle placards, cylinder labeling and load nesting and strapping at all times comply with Airgas safety standards (SAFECOR) and all government regulations including, but not limited to, those issued by the Department of Transportation (DOT), Environmental Protection Agency (EPA), Federal Motor Carrier Safety Administration (FMCSA), Food & Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA.
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Provide legal counsel and strategic guidance on regulatory matters related to the CPSC and FDA as they pertain to product safety and compliance. Regulatory experience with the Consumer Product Safety Commission (CPSC) or the Food and Drug Administration (FDA) is a significant advantage.
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Experience working with SOPs, GDP, GMP, CLIA, and the FDA. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. That’s how we tackle rare disease. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and.
$51,000 - $57,000 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Director/Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.
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Provide 24x7x365 coverage and support at the FDA White Oak Campus. NOC Technician ONSITE in Silver Spring, MD US citizenship required per government contract Must be able to obtain a Public Trust clearance Please note that new hires’ hours will be Monday – Friday, 8:00 AM – 4:30 PM ET until they have full access to tools and are completed training / are ready for independent shift work.
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Develop knowledge and experience using Public Sector IT with a focus in BI/Data Analytics and Account areas of: Federal Health (HHS - CMS/CDC/FDA), Civilian Agencies / Financial Services (IRS, SEC, ED), and Defense (DHA/Homeland Security.
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fda job in Washington, DC
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