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Minimum of combined ten years' experience in drugs and dietary supplements/NHP; including quality assurance, regulatory compliance, and/or R&D. Supports regulatory agency audits globally (FDA, HC and International Authorities) and certifying bodies (USP, UL) which includes inspection preparation, inspection conduct and inspection responses for all medical devices globally.
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Lead the launch planning process for APOC’s game-changing TBI test; define regulatory, market access, pricing, distribution, sales force organization and promotion strategies and develop sales forecasts.
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Develop a detailed understanding and strong application knowledge of the Thermo Fisher Scientific Nicolet FTIR product line, including the theory and operation of FTIR spectrometer and IR Microscope and their applications in material science research, industrial, pharmaceutical, environmental and bioscience.
$83,300 - $115,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Offer user support to references and core claims library within the Medical/Legal/Regulatory review and approval system (Veeva PromoMats) This role will focus on setup, maintenance, and management of a global centralized library of references and core claims to support the creation of content and the submission of materials for Medical, Legal and Regulatory review and approval.
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Maintain reference and claims library relevancy, working with Medical/Regulatory, conduct periodic audits of the information on file. This role will also provide user support and data entry for Client's Digital Asset Management system (DAM) which serves as the central repository for all marketing materials.
ExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Lead coordination and filing of N.A. Government Affairs Department’s U.S. Lobbying Disclosure Act reporting. This position, reporting directly to the Vice President, Global Government Affairs, is responsible for supporting the development of N.A. government and public affairs strategies, while working as an effective liaison with teams and colleagues in the Syensqo business units and functions to ensure a streamlined and coordinated approach.
$134,000 - $167,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Provides medical reference librarian functional expertise to support a capability standard and implement an operating model across markets in support of the centralized content management strategy. The name of the system was branded by Client as Content Central and is a SAAS system called a DAM. This role will harvest and enter reusable assets including images, text, claims, and metadata from existing Client content for upload into Veeva PromoMats.
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This role will also provide user support and data entry for client Digital Asset Management system (DAM) which serves as the central repository for all marketing materials. Our client, a leading pharmaceutical company, is hiring a Content Central Librarian on a contract basis.
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Experience working with regulatory approvals, including working with planning & zoning compliance. Ensure regulatory approval; this includes having an understanding of (and working with) planning & zoning compliance.
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Regulatory Compliance: Ensure strict adherence to all applicable regulatory requirements and industry standards governing cell therapy manufacturing in the USA, maintaining compliance with FDA regulations, GMP standards, and best practices.
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Dispose of radioactive materials and store radiopharmaceutical, following radiation safety procedures and regulatory guidelines. Dispose of radioactive materials and store radiopharmaceutical, following radiation safety procedures and regulatory guidelines.
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Manage schedules and streamline work between all team members and agencies including internal creative development project briefings to collect information in order to drive the discovery process with creative, strategy, production, development, regulatory, QA teams to deliver projects in a timely manner.
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Perform assigned activities in accordance with Otsuka Standard Operating Procedures, and regulatory requirements. Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
$52 - $54 an hourExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The attorney will be a ‘brand attorney’ who will advise commercial businesses and operations regarding approved and pipeline products, including working with Medical Affairs, Sales, Marketing, Market Access, Regulatory and others to ensure success.
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Collaborate closely with cross-functional teams, including Clinical Development, Commercial, Regulatory, and Medical Affairs, to drive the success of our product. Lead, mentor, and manage a high-performing national MSL team to ensure strategic alignment and execution of field medical affairs initiatives.
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regulatory affairs jobs Title: sr affairs associate Company: Thermo Fisher Scientific in Lawrence, NJ
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