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The Director, Regulatory Oversight works closely with Office of Research Integrity and Compliance leadership, the Office of Clinical Research (OCR) staff, Environmental Health and Safety, Office of General Counsel, regulatory committee Chairs and members, the Attending Veterinarian, and others in the GW research community to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact the research enterprise.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, and maintenance of products and processes in regulatory compliance with local regulations.
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As a Junior Economist, you will support various projects focusing on labor, immigration, health, transportation, and other regulatory areas. Assist senior economists in conducting economic and regulatory analyses related to policy areas such as labor markets, worker safety, immigration, health, and transportation.
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Author CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents, responses to information requests) to support the timely submissions of investigational and marketing applications.
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Other work assignments may include assisting with the development and implementation of work plans for radiological surveys, instrument operation and data collection, performing audits and inspections, environmental monitoring, sampling and analysis during site investigations and remediation, regulatory support, waste management, oversight of other health physics staff, training, and preparing technical reports.
$61,000 - $118,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Chamber is an early-stage health tech startup (backed by AlleyCorp) dedicated to advancing cardiovascular health and improving the healthcare industry through value-based care solutions.
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Provide regulatory guidance in areas such as fraud and abuse, state licensure, corporate practice of medicine/fee splitting rules, managed care, and health care antitrust. Demonstrated regulatory experience in areas such as fraud and abuse, state licensure, corporate practice of medicine/fee splitting rules, managed care, and health care antitrust.
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In collaboration with the Nursing Director, the Assistant Nursing Director is responsible for the leadership and management of the Medicine Behavioral Health unit at MedStar Washington Hospital Center.
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Maintains compliance with applicable regulatory agency requirements, including: The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), State and Local agencies, the Occupational Safety and Health Administration (OSHA), etc.
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The individual will assist with regulatory, legal, and legislative advocacy in the area of health policy and drug pricing, especially relating to the federal 340B discount drug program. Work directly with outside counsel on 340B Health filings, particularly amicus briefs, including assisting with fact and legal theory development and review.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Coordinate with Quality Assurance team to ensure that procured malaria as well as family planning and maternity child health commodities meet USAID quality standards, regulatory requirements, and international quality assurance protocols.
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The position is also responsible as needed for ensuring the effective delivery of corporate safety and regulatory legal advice and representation, with a focus on regulatory agency investigations, inquiries and requests for information (including by the Federal Railroad Administration (FRA), Occupational Safety and Health Administration (OSHA), National Transportation Safety Board (NTSB) and others), and advocacy in regulation development and industry compliance.
$211,140 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Position Overview In collaboration with the Nursing Director the Assistant Nursing Director is responsible for the leadership and management of the Medicine Behavioral Health unit at MedStar Washington Hospital Center.
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In collaboration with the Chief Clinical Officer, Senior Vice President (SVP), and Senior Director, supervise compliance with regulatory bodies for the agency. Collaborating with the Chief Clinical Officer or assigned representative, they provide leadership and counsel on matters concerning mental health and psychiatry.
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Specific experience advising biopharmaceutical companies on FDA regulatory legal issues including manufacturing, quality, and supply chain requirements ( e.g., GMPs, DSCSA, inspection-related issues), FDA’s regulation of digital health products and artificial intelligence and/or Hatch-Waxman and BPCIA is preferred.
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health regulatory jobs in District Heights, MD
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