- GE Vernova (Wilmington, NC)
- …with a common data environment + Define and support nuclear industry configuration management practices, document management , and change control processes ... provides direction and assistance to the Engineering teams to meet assigned configuration management objectives. As the Lead Engineer - Document Control (DC) you… more
- Integra LifeSciences (Princeton, NJ)
- …and oversee quality and compliance improvement and remediation strategies for document and record control, change management , and training administration ... and set new standards of care. The Sr. Manager, Document Control and Training is responsible for leading the...and is the Enterprise Compliance Master Plan (ECMP) Quality Management System (QMS) team leader with responsibility to design,… 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 ... Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)_ + Obtain input...(ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR… 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
- Parsons Corporation (Yuma, AZ)
- …ability to work collaboratively with diverse teams. **Key Responsibilities:** + ** Document Management :** Oversee the creation, distribution, tracking, and ... of formal education and work experience). + **Technical Skills:** Proficiency in document management software (eg, Aconex, SharePoint, or similar), Microsoft… more
- Parexel (Springfield, IL)
- …+ Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency ... into strategic impact? We're seeking a sharp, detail-driven Senior/Consultant, Regulatory Labeling to join a dedicated partnership with a...manage the review and approval of labeling in a document management system. + Electronic document… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and business objectives. + Advanced proficiency in regulatory information management systems (RIMS), electronic document management systems (EDMS) ... teams throughout the product lifecycle. This role will provide US strategic regulatory guidance to facilitate efficient and compliant drug development and… 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
- Sanofi Group (Cambridge, MA)
- …and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional ... strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug...presentation skills preferred + Ability to work in electronic document management systems (eg Veeva vault, Plai)… more
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