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This role is crucial in ensuring that all CMC aspects of drug development meet regulatory requirements globally, supporting Scorpion Therapeutics' mission to bring transformative oncology therapies to patients.
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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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Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance. The incumbent is also responsible for addressing and executing model risk management activities consistent with framework, best-practice and regulatory guidance.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA.
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Develop and execute a comprehensive third-party risk management strategy aligned with organizational objectives, regulatory requirements, and industry best practices. Collaborate with internal stakeholders including IT, legal, compliance, procurement, and senior leadership to integrate third-party risk management and information security into business processes.
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The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director, and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
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In addition, the work often includes historical research, filing the proposed work with regulatory agencies (LPC, SHPO, NPS, etc.) A valid driver’s license and willingness to travel throughout New England is essential, as work of this office includes projects throughout the region.
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Extensive experience of industry standards, codes, and regulations related to structural design and construction (e.g., ACI, AISC, ASCE, FEMA, FERC, U.S. Army Corps of Engineer structural and regulatory compliance.
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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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The Corporate Counsel will also assist in providing legal services on a variety of other matters, including commercial contracts, corporate governance, regulatory matters, intellectual property, dispute resolution, litigation, and other projects and initiatives.
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Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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Handle initial determinations, appeals and grievances within the scope of expertise as defined by MassHealth, Medicare, NCQA and the Division of Insurance and within the compliance requirements of key regulatory and accreditation entities.
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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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regulatory job Title: travel nurse Company: Next Move in Boston, MA
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