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Will serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Must have strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements. Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post-approval experience and international experience and negotiation experience with regulatory authorities on CMC issues related with biologic APIs.
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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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Collaborates with Government Regulatory Affairs, Network Management, Medical Economics, Benefit Administration, Provider Services, Audit, IT and Claim Operations to determine the impact of implementing policy changes.
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Demonstrated competence with payment reimbursement policy research and development within a health plan, government agency, regulatory or accreditation body. Research and monitor State/Federal regulatory policy changes and publications such as CMS, AMA, specialty societies, AAPC, Part B News for background on new code updates, impact assessments and recommend code set up parameters.
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Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents.
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Reporting to the Vice President, CMC, the Director will manage and lead the Analytical development function ensuring the development and implementation of phase appropriate methods that meet international regulatory requirements for drug substance and drug product safety.
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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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The person will work directly with stakeholders across – ESG Investments, ESG Product Strategy, ESG Data and Operations, Client, Product and Regulatory Reporting, and Enterprise Risk Management to understand their data and reporting requirements and to translate requirements into functional specifications for technology partners building/ enhancing IT solutions for ESG reporting.
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Assessing regulatory requirements for regulatory capital and compliance issues in the banking industry (FRTB, CCAR, ICAAP, PRA, Volker, Basel III etc.) A career in Capital Management, within Financial Services Advisory Risk & Regulatory, will allow you to advise financial institutions on continuing to enhance their stress testing capabilities and responding to regulatory feedback.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Familiarity with regulatory guidelines and standards related to bioanalytical data review. Ensure data integrity and quality by adhering to internal and other regulatory guidelines. Work closely with scientists within the in-vivo pharmacology group to verify in-vivo and Pharmacodynamic (qPCR) data.
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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Responsibilities are interchangeable within job titles of medical laboratory scientist (MLS), medical technologist or clinical laboratory scientist.
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Any specific experience with data management best practices, data governance, data quality controls, regional or regulatory reporting requirements is preferable. As pioneers in index, ETF, and ESG investing, we are always inventing new ways to invest.
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hitrust regulatory jobs in Waltham, MA
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