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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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In order to perform the essential functions of the position, candidates must have the requisite experience, which includes at least 2 to 3 years as a licensed New Jersey attorney working in State government (for the Legislature or Executive Branch) or in the private sector in the government and regulatory affairs arena.
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Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety and Epidemiology (e.g., product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing.
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The Sarbanes-Oxley (SOX) Control and Compliance Manager will lead the Company’s internal controls program, perform regulatory compliance audits as needed, and support the Company’s Environmental, Social and Governance (ESG) and Enterprise Risk Management (ERM) programs.
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Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions with support of an experienced COM. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
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Full Knowledge of the drug development, study conduct processes, regulations related to Data Management and clinical research such as CFR Title 21, ICH Guidelines, EU Directives, GCP and relevant regulatory compliance.
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Offer user support to references and core claims library within the Medical/Legal/Regulatory review and approval system (Veeva PromoMats) ~ Maintain reference and claims library relevancy, working with Medical/Regulatory, conduct periodic audits of the information on file.
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The Route Supervisor ensures adherence to all accident prevention programs and leads operations to ensure compliance with all safety, environmental, operating, regulatory, accounting, ethics and other standards.
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The Sr, Contracts Manager is responsible for fulfilling various tasks within the legal team from contract negotiation with regulatory and professional clients, contract review; issue identification; contract proofreading, legal research, and additional legal projects; and monitoring of business practices for legal and contract compliance.
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Lead a portfolio of diverse technology projects and a team of developers with deep experience in distributed microservices, and full stack systems to create solutions that help meet regulatory needs for the company.
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The new SCA Health represents who we are today and where we are going—and the growing career opportunities for YOU. Responsibilities The Medical Records Specialist processes and organizes medical records in a timely manner and in compliance with regulatory and accrediting agencies, as well as state and federal laws.
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Cooperates with, participates in, and supports the adherence to all internal policies, procedures, and practices in support of risk management and overall safety and soundness and the Bank's compliance with all regulatory requirements, i.e. Community Reinvestment Act (CRA), Bank Secrecy Act (BSA), Equal Credit Opportunity Act, etc.
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The EHS Specialist/Coordinator will serve as a subject matter expert on all safety, compliance, regulatory and related insurance requirements. We are searching for an eager EHS Coordinator to join our dynamic team looking to make a lasting impression on the success of the organization.
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The GTL ensures global project team’s responsibility for the identification and design of a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound.
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Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. Audit for compliance as pertains to Catalent SOPs, regulatory, and customer requirementsSupport Corporate and local Quality policies and initiatives.
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regulatory affairs jobs Title: intern Company: Amgen in Levittown, PA
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