- AbbVie (San Francisco, CA)
- …regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation Qualifications Qualifications + A ... Purpose The medical writer is responsible for providing clinical regulatory document support to clinical teams, ensuring successful preparation of high… more
- Gilead Sciences, Inc. (Santa Monica, 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
- 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
- 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
- AECOM (Sacramento, CA)
- …external regulatory requirements. **JOB RESPONSIBILITIES:** + Maintain and enforce document control processes from ** document creation to final archiving** . ... (eg, ISO 9001, project specs). + Ensure best practices are applied for preparation and maintenance of document registers, metadata reports, and compliance logs.… 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
- 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
- LSI Solutions (Victor, NY)
- …will possess strong administrative skills, including proficiency in Microsoft Office, document preparation , and organizing and maintaining a master scheduling ... + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. + Assist in review and… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Hologic (Newark, DE)
- …and confidence. The Regulatory Affairs Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and ... activities associated with warning letter remediation efforts including the preparation and compiling of documentation packages for regulatory submissions,… more
- Ameren (Steedman, MO)
- …to regular full-time employees. Job Description **About The Position** The Regulatory Affairs / Licensing Engineer provides support to the Callaway Energy Center ... in the areas of regulatory and licensing issues. **Key responsibilities include** ...defense of licensing positions with the NRC. + Coordinate preparation of submittals to change or amend the Callaway… more
- American Electric Power (Columbus, OH)
- … activities. Position requires interaction and communication with various parties to regulatory proceedings as well as preparation and/or review of data, ... and testimony to support regulatory activities. At conclusion of regulatory proceedings, position requires preparation of accounting instructions to other… more
- American Electric Power (Tulsa, OK)
- … activities. Position requires interaction and communication with various parties to regulatory proceedings as well as preparation and/or review of data, ... and testimony to support regulatory activities . At conclusion of regulatory proceedings, position requires preparation of accounting instructions to other… more
- Bank of America (Jersey City, NJ)
- …II role is within the GRR Broker Dealer organization responsible for the preparation of Regulatory Reporting calculations (SEC Rule 15c3-3) for locally regulated ... other legalentities. Responsiblefor performing and documenting control processes, and the preparation of data submissions for regulatory reporting teams.… more
- System One (Florham Park, NJ)
- …need to have formatting experience) Overview: This role will support in the preparation and submission of electronic regulatory documents through the FDA and ... ensure compliance with applicable laws and regulations. This includes publishing regulatory documents, managing document tracking and version control,… more
- Duke Energy (Nashville, TN)
- …and is able to perform intermediate financial analysis work including the preparation and development of regulatory filings, determining the financial impact ... utility peers. Principle Accountabilities: + Independently work on various aspects of preparation and justification of the Company's proposed regulatory filings,… more