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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Collaborate with Clinical Development, Regulatory Affairs, and other key departments to promote a robust drug safety culture. Lead and author key pharmacovigilance documents, including medical safety assessments and regulatory responses, applying regulatory guidance for safety surveillance and document authorship.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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The Executive Office of Energy and Environmental Affairs Secretariat (EOEEA) provides oversight of the Commonwealth’s energy and environmental agencies, namely, the Division of Energy Resources (DOER), Department of Public Utilities (DPU), Department of Environmental Protection (DEP), Department of Conservation and Recreation (DCR), Department of Fish and Game (DFG), and Department of Agricultural Resources (DAR.
$93,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Works cooperatively with institutional colleagues, including but not limited to: Concert Operations, Professional Writing & Technology Division, Music Education, Music Therapy, Institutional Advancement, Academic Affairs, Music Production and Engineering.
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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Comprised of teams dedicated to internal/external communications, public affairs, and policy, our environment is fast-paced, ultra-collaborative, and ever-changing. This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent.
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Familiarity with regulatory requirements for cosmetic product and raw materials in major markets (e.g., FDA, MOCRA, NA, EU in priority)Familiarity with GLP, cGMP, and QA/QC personal care industry best practices.
$140,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Closely collaborate with Clinical Operations, GPS Operations, Regulatory Affairs, and applicable vendors for seamless PV processes, serving as a leader, mentor and ambassador for GPS. This includes collaborating with Clinical Research, Clinical Operations, Medical Scientific Affairs, and/or vendors to develop and monitor the clinical trial safety.
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In this collaborative role, you will be responsible for the research and development of AML procedures, regulatory engagement, and issue management related to our AML/KYC program, making a significant impact as our business continues to grow.
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Act as the technical writing expert for CMC regulatory submission documents in cross-functional project teams and as a deputy to the Director, Regulatory Affairs CMC in various internal and external meetings – representing Regulatory CMC as needed.
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Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM), or Certified Fraud Examiner (CFE) + Assess the execution of the annual BSA audit work as well as regulatory and partner exams by creating presentation materials and providing timely responses to inquiries.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP, and behavioral health, as well as the associated and relevant federal, state, and local regulatory entities.
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regulatory affairs jobs Company: Travelnursesource in Boston, WA, Ohio
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