- Novo Nordisk Inc. (Plainsboro, NJ)
- …Prepare routine correspondence Provide proactive support and technical assistance during preparation and review of regulatory documents As assigned, participate ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...in project teams Assist with technical preparation for FDA meetings, including review of draft questions… more
- Merck & Co. (North Wales, PA)
- …mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …letter of authorization, etc.) for US regulatory submissions.Support FDA meeting preparation including preparation of briefing document , meeting request, ... response to FDA preliminary comments and logistics.Support FDA meeting preparation including preparation of briefing document , meeting request, response to… more
- Eisai, Inc (Jersey City, NJ)
- …candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.Essential ... across functional areas to obtain all applicable source materials Leads the preparation of clinical sections of submission documents, such as the briefing books,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Marketing, Managed Markets, Trade, Corporate Communications, Legal, Regulatory , Medical Information and Medical Affairs. External relationships include ... to develop all pre and post-convention materials, including Tier 1 document , Tier 2 pre-show communication and pre-convention slide presentations (coordinating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach ... cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety message… more
- Eisai, Inc (Nutley, NJ)
- …with creating, updating and maintaining project trackers in EPIC Provides support for document preparation and follow-up ( eg Informed Consent Form, eTMF fling ... Item follow-up Attends CRO and vendor teleconferences as applicable Review regulatory packet for investigational product release Provide user access management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …impact assessment, and CAPA/EC determination.Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits ... of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification (CPV)Recognize and… more
- Vera Therapeutics (Brisbane, CA)
- … regulatory and clinical document production. * Support clinical and regulatory document preparation (eg, eCTD modules, briefing documents, study ... clear, accurate, and effective presentation of analyses and messaging. * Manage document timelines, ensuring alignment with overall regulatory and program… more
- JPMorgan Chase (New York, NY)
- …automation solutions **Preferred qualifications, capabilities, and skills:** + Experience in regulatory document preparation and governance a plus ... function is responsible for the first-line critical review of internal and regulatory governance materials in keeping with the OCC's Heightened Standards for… more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …Description:** **JOB SUMMARY:** Responsible for regulatory assessments, coordination and preparation of document packages for regulatory submissions ... of changes on existing products. + Coordinate and prepare document packages for regulatory submissions to the...+ 3 -5 years of experience in Medical devices regulatory submissions required. + Experience with successful preparation… more
- Santa Clara Valley Water District (CA)
- …of California Environmental Quality Act (CEQA) and/or National Environmental Policy Act (NEPA) document preparation or regulatory compliance? If so, consider ... or capital projects or facilities on the community and the environment. + Preparation of CEQA/NEPA documents and/or successful regulatory permit negotiation and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …In this role you will offer clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for various ... guidelines, ICH guidance, and Teva standards + Lead/contribute to the preparation /revision of document templates + Participate in the recruiting/hiring process,… more
- Stanford Health Care (Newark, CA)
- …medical records .The Document Imaging (DI) Specialist is responsible for document preparation , scanning, and indexing paper documents to accurately file in ... of America) **This is a Stanford Health Care job.** **A Brief Overview** The Document Imaging Specialist, under the leadership of the HIM Document Imaging… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …authorization, etc.) for US regulatory submissions. + Support FDA meeting preparation including preparation of briefing document , meeting request, ... response to FDA preliminary comments and logistics. + Support FDA meeting preparation including preparation of briefing document , meeting request, response… more
- Sanofi Group (Bridgewater, NJ)
- …and/or innovative biologics products + Demonstrated experience with driving the preparation of regulatory documents (eg (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health ... **Job title: Regulatory Strategist** + **Location:** Cambridge, MA or Bridgewater,...their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading… more
- System One (Florham Park, NJ)
- …The Senior Regulatory Operations Associate Contractor will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, ... The scope of this role includes formatting and publishing regulatory documents, managing document tracking and version...systems to this role. Responsibilities + Lead in the preparation and submittal of regulatory applications and… 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
- Actalent (Cambridge, MA)
- …ensuring accuracy and compliance, supporting training management, and assisting with regulatory inspection preparation . This hybrid role includes both remote ... Job Title: Document Control Specialist Position Summary: We are seeking...tasks, creating quizzes, and formatting SOPs. + Assist in regulatory inspection preparation and provide onsite support… more
- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as Veeva Systems products, ... health and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist C Job Profile Title Clinical Research Regulatory … more
