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Executes model risk management activities and projects consistent with the Enterprise MRM framework, industry best practices, and regulatory guidance. The incumbent is also responsible for addressing and executing model risk management activities consistent with framework, best practices, and regulatory guidance.
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Ensure all regulatory trainings and approvals are met before and after all grant submissions and awards are made, including but not limited to IRB, IACUC, FCOI and so forth as applicable. Participate in the development and implementation of new internal policies, procedures or practices to ensure compliance in the conduct of research applicable with federal regulations, state and all other regulatory bodies governing grant compliance.
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Ability to work independently to identify problems and solutions that meet the occasionally competing needs of research, other internal departments, sponsoring agencies or regulatory bodies. Remain abreast of current trends, practices, regulatory and/or policy changes of granting entities, which may impact internal processes or programs.
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Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)Manage upstream and downstream scientistQualifications:M.S or Ph. D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience & prior management experienceExperience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc.
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Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Program and Project Management: Oversee the selection and administration of project tracking tools, optimizing program management across global policy, compliance, safety, and regulatory affairs teams.
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Ten (10) years of regulatory experience for small molecules and biologics within the pharmaceutical or biotechnology industry, along with demonstrated success as a PV, Regulatory Affairs organizational leader, able to lead, direct and develop member of the PV regulatory function.
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Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies. ·Partners with Clinical Operations, Medical Affairs/local country offices to obtain local insights into country and site selection.
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From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
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Maintain awareness of current trends in HR technology and understand statutory and regulatory requirements affecting HR, Benefits, Recruitment, and Payroll systems. Our immersive understanding of these industries – combined with our expertise across high-stakes litigation and dispute resolution, world-class regulatory compliance and advisory services, and complex transactions – sets us apart.
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Responsibilities: Manages activities of workers compensation and disability claims, case management and utilization review according to established policies and procedures and applicable legal and regulatory guidelines.
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Lead Trinity’s internal client auditing and external client audit activities, which requires working knowledge of Life Science regulatory requirements contractually passed through to its vendors like Trinity (e.g., pertinent FDA regulations, pharmacovigilance, data privacy, transparency reporting, etc.
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Experience with regulatory standards around healthcare such as HIPAA,HITRUST, etc. Cloud security standards and best practices, including secure access ,PAM, hybrid credential management, SSO, federated IAM, etc.
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Required Knowledge/SkillsIn-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc. Ensure quality and compliance frameworks, guidance, and systems are in place to keep the products current with industry and health authority regulatory expectations as well as Vertex’s QMS for products throughout the life cycle development.
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regulatory affairs jobs Title: principal consultant in Woburn, MA
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