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The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
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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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Expert knowledge in cloud architecture, DevSecOps, vulnerability management, and familiarity with regulatory frameworks such as SOC, ISO, and FedRAMP. - Develop, implement, and maintain compliance and regulatory guidance and security and privacy self-assessments for cloud and traditional data center environments.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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Partner with CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets to ensure appropriate quality processes and procedures are implemented for commercial cell-therapy GMP manufacturing, at-scale and in-compliance.
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Strong knowledge and hands-on experience with good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines. Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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POSITION SUMMARY: Under the direction and guidance of the Associate Vice President, Career and Digital Strategy, the Senior Director of Industry and Employer Engagement will develop and lead the implementation of a comprehensive strategic plan that drives engagement with industry, including employers, recruiters and alumni in coordination with Academic Affairs, the International Career Center (ICC) and Alumni Affairs.
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Brief Description: The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. Understanding of regulatory requirements for field-based personnel Experience in oncology Experience as a Medical Science Liaison with a strong track record of success is strongly preferred Required/Preferred Education and Licenses Advanced degree (PharmD, MD, PhD or equivalent) with a minimum of 3 years’ experience in oncology medicine.
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Ensures ongoing compliance with all applicable regulatory agencies for department section (including but not limited to: CLIA, TJC, OSHA, DPH, HCFA, FDA, AABB, NCCLS). Participates in hospital-wide Quality Assurance Program as designed by regulatory agencies, by the BMC Quality and Patient Safety Department or by the departmental/sectional Quality Assurance Policies.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards. Lead and track analytical development commitments to support all CMC filing activities for pre-INDs, INDs, IMPDs, CTAs and BLAs, draft and review of regulatory filings, and address RTQs. Assure all documentation and other regulatory compliance systems are maintained according to GSK corporate standards.
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An advanced clinical degree (MD, DO, PhD, PharmD) and a minimum of 3 years in medical affairs or a related field. We are looking for a dynamic Director of Medical Affairs with a passion for medical communication and supporting scientific partnerships.
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The Associate Director, Clinical Research Program will oversee all clinical trials and translational research operations, regulatory and compliance within the. Support for Clinical Research Manager, Regulatory Operations Manager, CTO Project Manager(s) in operationalizing the Portfolio Workload Tool with direct supervision from the CTO.
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Analyse energy market trends, policies, and regulatory frameworks that impact the offshore wind industry in the UK, offering comprehensive insights into potential opportunities and challenges. Conduct thorough economic assessments of offshore wind projects, including cost-benefit analyses, financial modelling, and risk assessments, to inform project feasibility and investment decisions.
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Understand and adhere to all Bank Secrecy Act and Anti- Money Laundering (BSA/AML), regulatory, security, retail banking and bank- wide policies and procedures. Understand and adhere to all Bank Secrecy Act and Anti- Money Laundering (BSA/AML), regulatory, security, retail banking and bank- wide policies and procedures.
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regulatory affairs jobs Title: sr regulatory affairs associate in Somerville, MA
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