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G, clinical operations study team members, regulatory affairs, quality assurance, and information technology) to ensure TMF compliance and quality) Manage the Trial Master file in compliance with regulatory requirements and company SOPs.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression.
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The Associate will and work closely with product, marketing and compliance groups and FINRA staff to help ensure regulatory compliance of marketing and sales collateral, digital content, and market commentary.
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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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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. The Senior Manager, Medical Writing will be responsible for clinical regulatory documents.
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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. Responsibilities Project Management: Lead the engineering team in the development and execution of DeltaV DCS projects from concept to completion.
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Clinical Director in Translational Medicine, Cardiovascular & Respiratory Early Clinical Development
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As a key member/leader of an early development team, working in close collaboration with internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early clinical development strategy.
$247,700 - $390,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position sits on the Risk Product Management (RPM) team which plays a crucial role in assessing, mitigating, and managing risk across Cyber A&E. The Cyber A&E Audit & Regulatory Lead will play a pivotal role in ensuring adherence to industry regulations and standards, as well as proactively mitigating risks through comprehensive audit and regulatory practices.
$140,000 - $222,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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Work with the various departments on campus, both within and outside Student Affairs to provide educational opportunities around issues of religious diversity, spirituality, and ethics to further the development of students.
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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The Regulatory Affairs Director (RAD), Oncology Cell and Gene Therapy provides strategic regulatory leadership to influence the development of our innovative products across all stages of development.
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Initiates and/or completes regulatory and other forms, such as MassHealth Long-Term Care and DMH/DDS PASSR forms and processes the completed forms with the appropriate agencies. ·Works collaboratively with the Case Manager, Brewster Ambulance Services Transportation Coordinator and the VPNE care van ambassador to coordinate the various modes of discharge transportation.
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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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Strong scientific background in immunology or related field supported by publication record in these areas Expertise in dermatology or rheumatology highly desirable Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro diagnostics, protocol design, and/or experience in development strategy preferred.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Cambridge, MA
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