- Terumo Neuro (Aliso Viejo, CA)
- …and results. + Partner with clinical research project managers and Medical Affairs and Safety Manager to ensure safety startup activities and pace of ... milestones and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise to provide input… more
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... Oversee project -related training of investigators, study site personnel, and AbbVie...scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead… more
- Envista Holdings Corporation (Pomona, CA)
- …whether to accept the product and future purchases from the vendor. + Supports Regulatory Affairs with their activities related to submissions and notified body ... develop, implement, and maintain quality assurance protocols that comply with regulatory requirements and industry standards. The Sr. Quality Engineer will possess… more
- Abbott (Alameda, CA)
- …be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Proficient with Microsoft Suite. **Travel Requirements** + ... (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements. + Responsible for assisting senior staff in planning… more
- Sumitomo Pharma (Sacramento, CA)
- …+ Exceptional collaboration and cross-functional leadership skills. + Detail-oriented project manager with strong organizational and timeline management ... Medical Affairs , Market Access, Omnichannel, Patient Marketing, Legal, and Regulatory to ensure unified execution and strategic cohesion. + Lead co-promotional… more
- AbbVie (San Francisco, CA)
- …who support clinical trial execution and the Development and Global Medical Affairs Therapeutic Area MDs/SDs. + Key contributor to the portfolio planning process ... Reviews and provides clinical operations content to clinical and regulatory documents (eg, INDs, IB, NDAs, BLAs, MAA, ...leadership and direct supervision of 4 - 15 study manager (s) and up to 30 indirect staff, career development… more