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Coordinates with publishing team(s) to submit FDA regulatory submissions through the Electronic Submissions Gateway (ESG), including QC review of outputs from publishing team. Provides quality review of internal communications, client deliverables, and FDA regulatory submissions.
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Familiarity with FDA regulatory requirements for IND and IDE; preferably those related to investigational biologic agents regulated by the FDA, and guidelines for facilitating clinical human subjects research.
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Amgens Center for Design and Analysis Organization has a new opportunity for a Safety Statistician, Senior Manager to provide independent statistical expertise on safety assessment activities in support of FDA safety reporting requirements.
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Experience working with the US Food and Drug Administration (FDA) or related Department of Health and Human Services (HHS) operating division in the past 12 months. Existing strong relationships with FDA and other HHS leaders.
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One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial.
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Minimum Qualifications Education Bachelor's degree in related field required Master's degree preferred Experience Excellent working knowledge of FDA, ICH, GCP and other regulatory functions required 3-4 years Experience in Phase I-IV clinical trials and knowledge of medical field required Knowledge, Skills, and Abilities Excellent problem-solving skills and ability to exercise independent judgment.
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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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A background in product risk regulatory work, and experience with the Consumer Product Safety Commission (CPSC), Food and Drug Administration (FDA) and the National Highway Traffic Safety Administration (NHTSA), is preferred.
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Demonstrable understanding of U.S. FDA regulatory requirements and policy. Regulatory experience within the medical device industry or a regulatory agency, such as the FDA.
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Job DetailsGoodwin seeks a highly qualified mid-level associate with 2–3 years of experience to join our Life Sciences Regulatory & Compliance Practice. Candidates applying for attorney positions with Goodwin should have outstanding academic credentials, comparable law firm experience or commensurate experience working at the FDA or in industry, excellent written and verbal communication skills and a desire to learn from our experienced, deep bench of senior lawyers.
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In-depth knowledge of life sciences BMS (Building Management Systems) regulatory requirements (e.g., FDA, EMA, ISO) etc. Building Management Solutions (BMS) Project Manager (remote) Project Manager will lead and manage BMS (Building Management Systems) offshore technical team and provide technical solution and architecture inputs for Life Sciences projects involving Siemens Desigo CC for HVAC control and plant utility distribution systems.
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Firm Type: Law Firm, Experience: 4 Years, A law firm in Washington, DC is seeking an FDA Healthcare Associate Attorney to provide expert legal advice and support on FDA regulatory matters related to drug and medical device compliance.
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Regulatory awareness (EU MDR and FDA clinical evidence and evaluations) Additional Skills: Ability to jump into clinical revision reports for regulatory purposes, CRE experience with software devices.
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4-5 years of experience in FDA regulatory compliance, preferably in a law firm or corporate setting. Provide legal advice and support on FDA regulatory matters related to drug and medical device compliance.
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Keywords : senior director, clinical program lead, late-stage clinical development, clinical trials, global, strategy, hematology, lymphoma, oncology, targeted therapies, ADCs, antibody-drug conjugates, program, asset, label extension, life-cycle management, pharma, biotech, biopharma, MD, medical doctor, phase I, phase II, phase III, FDA.
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fda regulatory jobs in Falls Church, VA
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