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Internal stakeholders include: VP Immunology, International Market Access and Pricing; Global Health Economics and Outcomes Research; Affiliates; Areas; R&D; Commercial; Medical and Regulatory; Governance bodies.
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Partner with cross-functional groups (Brand Marketing, Legal, Regulatory, Medical, Sales, Sales Training, Consumer Marketing, Market Analytics and Business Insights, Finance, HR, OEC, etc.) to ensure integration and consistency of professional business strategies and regulatory compliance of promotional materials.
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Play a leadership role alongside the VP, ESG in strategic alignment with regulatory reporting obligations, including CSRD, SEC Climate Rule, California climate laws and other ESG regulations, and analysis of how new external reporting and disclosure translates into business risk and opportunity.
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Advanced knowledge and understanding in the core areas of government affairs and policy (Stakeholder and Alliance Development, Government Relations, Political/Campaign experience, Access and Reimbursement Public Policy and Economic Analysis) to maximize colleague contributions.
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What you'll be doingThe Medical Science Liaison (MSL) functions as a field-based member of the Medical Affairs group in Medication Delivery, Baxter Healthcare Corporation. This role will collaborate with the internal Commercial and Medical Affairs teams in their therapeutic area of expertise to provide scientific information relevant to the launch of new products, and support key product strategies and publications.
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Obtain Licenses: Become a FINRA (Financial Industry Regulatory Authority) Registered Representative by studying for and obtaining your SIE, Series 7 Top Off and Series 66 licenses, fully paid for and sponsored by Fidelity.
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Exposure working with regulatory/listing agencies such as UL, FM, CSA, and CE mark One (1) or more years of experience in the use of PTC Windchill. Demonstrate proficiency in tools such as Microsoft suite of tools, Pro-E/CREO, PDMLink, Configured product Articulate and skillful at creating information, written or otherwise Exhibits good analytical skills with ability to organize, implement projects to detailed timelines and budgets Familiarity with the most current Product Lifecycle Management systems and methods, CAD systems and tools, project management, content management systems, and the communication and interaction between IT systems.
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Bachelor’s degree and at least 4 years of experience in Regulatory Affairs and/or Compliance OR a High School diploma/GED and at least 7 years of experience in Regulatory Affairs and/or Compliance.
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5+ years of experience in external affairs, public affairs, government relations, political consulting, or related experience. Lead development and implementation of a public affairs strategy including community relations, stakeholder engagement and grassroots constituent support for the Company.
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Adapting documentation to various regulatory frameworks such as GDPR, HIPAA, PCI-DSS, etc. Ability to lead the in developing audit/assessment plan as required for different regulatory or standard’s needs.
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The Senior Manager Technical Support will manage a staff of direct reports and support On-Market Design Changes, Supplier Notifications, Manufacturing and Supply Chain Disruptions, CAPA Investigations, support both CAPA & Material Review Boards, and Regulatory Support – Providing Technical Justification for Submissions and Product Reviews; State of the Start and Literature Reviews.
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Serve as a ESG subject matter expert, content creator and lead editor for the company’s sustainability messaging and storytelling; proactively manage sustainability communication program execution and channels (e.g., web, intranet, Powerpoint presentations, newsroom, etc.
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Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory.
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Establish operating mechanisms for collaboration between Rx BA projects and the M&D division, including Clinical Development, Regulatory Affairs and Medical Affairs. Define evidence generation strategies, including clinical development, HEOR and regulatory strategies for all Rx BA projects, across imaging agents, medical devices, digital therapeutics and software.
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The Sr. Regulatory Affairs Specialist will report to the Sr. Director of Regulatory Affairs. We currently have a great opportunity available for a Sr. Regulatory Affairs Specialist to work on Cybersecurity related regulations.
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regulatory affairs jobs Title: regulatory specialist Company: Amgen in Riverwoods, IL
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