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Staying current with industry standards such as CDISC, and the regulatory requirements related to their use. Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer.
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Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
$142,500 - $237,500 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Ensure that the biomedical equipment is in compliance with Federal, State, and/or applicable regulatory requirements; implement quality control standards and maintain budget and vendor relationships.
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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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The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production. Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.
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The base salary range for the Associate Director, Global RWE (Real World Evidence), Global Medical Affairs - Neurology is from :181,000-237,600. This role primarily focuses on late-stage pipeline and marketed products, interfaces with cross-functional teams including US medical affairs, marketing, market access global value and access teams, commercial to align strategies in customer research activities and development of external communication materials.
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Provide project strategy, oversight and direction for regulatory compliance, environmental permitting and land use projects. Ramboll is seeking a highly motivated Manager to lead projects and tasks primarily in regulatory compliance and land use permitting.
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While the detailed responsibilities of this position are numerous and important, the primary goal is to ensure the smooth functioning of the administration of Graduate student affairs for the department and to assist the DGS in administering the resources needed for graduate student success.
$28 - $30 an hourTemporaryExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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This position plays a PM and CMC leading role in Technology Transfer and CMC regulatory filings by setting clear objectives and empowering their team. Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, and distribution across multiple regions.
$127,900 - $172,900 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The *Internal Audit Control Manager *– Compliance Subject Matter expert is primarily accountable for ensuring adequate and appropriate audit coverage of federal/state/GSE requirements applicable to the organization by maintaining the compliance matrix and providing input to the audit plan and advice to audit teams regarding consumer compliance regulatory applicability.
$90,000 - $100,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Foster connectivity and build alignment across all major functions (e.g. Development, R&D, HEOR, Value Access & Pricing, MEG Regulatory, Commercial, Corporate Affairs, etc.) The WW Eliquis Medical Lead is accountable for medical leadership, strategy and execution of medical affairs-related activities for Eliquis within the broad global Eliquis Alliance framework.
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Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly desired. Minimum of 10 years drug development/FDA/regulatory related industry experience required.
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Offer user support and feedback on references and core claims library within the Medical/Legal/Regulatory review and approval system (Veeva Vault PromoMats) Maintain reference and claims library relevancy, working with Medical/Regulatory, conduct periodic audits of the information on file.
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Familiarity with cell therapy processes and cGMP is strongly preferred. Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support. Other responsibilities include participation in process tech transfer and incoming process changes, communicating the changes to applicable departments, and leading the process improvement projects at the site.
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regulatory affairs jobs Title: sr affairs associate Company: Thermo Fisher Scientific in Lawrence, NJ
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