- Gilead Sciences, Inc. (Foster City, CA)
- …document templates, standards, and medical writing processes. + Build expertise in regulatory document preparation , particularly at the individual study ... to effectively engage with diverse team members. + Solid understanding of regulatory document requirements and industry guidelines. + Proficiency in Microsoft… more
- AbbVie (North Chicago, IL)
- … requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Competent/expertise in ... . Job Description + Conducts independent quality control reviews of regulatory , scientific, and clinical documents with applicable checklists by checking against… more
- GE Vernova (Wilmington, NC)
- …(FMEA), probabilistic risk analysis (PRA), and similar techniques. + Support nuclear regulatory certification or licensing document preparation , + Perform ... Easy5/MSC, Simulink-MATLAB/MathWorks, Mathcad/PTC, 3KeyMaster/WSC, ETAP, SKM], + Change, configuration, document and bill of material (BOM) management [e.g.; ENOVIA/Dassault-Systemes].… more
- Legrand NA (Canonsburg, PA)
- …documentation, including procedures, manuals, records, and technical reports. + Regulatory Compliance Leadership:Ensure all document control practices comply ... and deliver advanced training programs for staff and stakeholders on document control policies, systems, and regulatory updates. Benefit Highlights:… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required ... the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. + Proven expertise in the preparation , compilation,… more
- Actalent (Parsippany Troy Hills, NJ)
- …and maintaining audit trails. + Execute comprehensive archival processes, including document preparation , inventorying, and coordination of internal and offsite ... Good Documentation Practices (GDP) compliance, ensuring adherence to formatting standards and regulatory requirements. Document Systems & Compliance + Manage the… more
- LA Care Health Plan (Los Angeles, CA)
- …with business units in audit universe preparation and validation. Assists in document preparation for regulatory and internal audits. Regulatory ... the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- Sanofi Group (Morristown, NJ)
- …experience (regionally and/or global) + Significant track record of US regulatory expertise required (demonstrated experience with preparation of BLA/NDA, ... **Job Title:** Regulatory Strategist - mRNA Vaccines **Location** : Swiftwater,...team members. This includes the authoring of the briefing document focused on the strategy and scientific content, and… more
- Actalent (New Albany, OH)
- … document control and training SOPs. + Provide assistance during local audits/ regulatory inspections and assist with inspection preparation . + Perform all ... Research Document Control Technician Job Description As a Document Control Technician, you will guide documents through the creation and revision process,… more
- North Wind Group (Richland, WA)
- Location: Richland, Washington Title: Document Control and Records Specialist Lead Schedule (FT/PT): Regular Full Time Travel Required: No Clearance: Ability to ... security control and force protection, and environmental services. POSITION PURPOSE: The Document Control & Records Specialist Lead supports the Document Control… more
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