- Takeda Pharmaceuticals (Boston, MA)
- …manage multiple projects simultaneously while meeting deadlines. + Strong understanding of regulatory guidelines and document management standards. + Ability ... + Enhancing technical capabilities. + Optimizing processes related to document management within the nonclinical environment. **_ACCOUNTABILITIES_** +… more
- GRAIL (Durham, NC)
- …for supporting the maintenance, delivery, and continuous improvement of GRAIL's Records and Document Management , Systems, and Education- with an emphasis on the ... Address, respond-to, and complete NCRs, CAPAs, and Internal/External Audit Findings associated with document management needs and gaps. + Generate data for key… more
- PSEG (Newark, NJ)
- …Experience leading Document Control teams. + Previous implementation of Electronic Document Management System + Experience to effectively lead and motivate ... is created, updated, maintained and stored according to PSE&G policies, Regulatory requirements, contract terms, best practices, and quality- management -system… more
- Lilly (Indianapolis, IN)
- …highly effective global regulatory team. The GRL creates and maintains the Regulatory Strategy Document (RSD) and ensures local plans, built by the regional ... Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD) + Acquire input...(ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory… more
- Chiesi (Boston, MA)
- …FDA OPDP + Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems a plus + Demonstrated expertise in regulatory ... guidance documents that impact domestic and international activities related to Regulatory activities. + Interact with senior management , external departments… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Cambrex High Point (High Point, NC)
- … filings. Responsibilities + Provide guidance and input to project teams on regulatory requirements related to document submissions in support of client ... Provide feedback and/or lead project and site risk assessments relative to quality management systems and impact to client projects/ regulatory filings. + Obtain,… more
- Catalent Pharma Solutions (Manassas, VA)
- …and maintenance of the Quality System documentation. Communicate any deviations to management . The ** Document Control Specialist** will assist the Quality ... ** Document Control Specialist** **Position Summary** Catalent, Inc. is...batch production records to verify compliance with internal and regulatory requirements. + Support third-party certifications and customer audits… more
- ThermoFisher Scientific (Indianapolis, IN)
- …tasks, involving the gathering, assessment, and submission of documents to regulatory bodies. + Guides electronic Trial Master Files (eTMF) throughout feasibility, ... completion of assigned tasks (eg, system integrity, product vendors, site management ) + Supports with administrative tasks related to inputting purchase orders,… more
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