- BeiGene (San Mateo, CA)
- **General Description:** The incumbent will report to the Associate Director, Drug Product Commercial Small Molecule, External Supply Quality and be responsible ... for supporting activities relating to BeiGene's external GMP operations in the US as well as internal BeiGene GMP processes, ensuring procedures and systems are in place to support BeiGene's commercial products. The incumbent will provide support in ensuring… more
- Amazon (Sunnyvale, CA)
- …of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. The ideal ... practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products. Key job responsibilities * Acts as a… more
- Boehringer Ingelheim (Fremont, CA)
- …labeling and packaging, batch record review, batch disposition, new product introduction/ product transfer, external quality and laboratories. Demonstrates ... critical issues within area assigned and may escalate to senior management team based on severity of the issue....adherence to regulated QA activities for cGMP operations. **Sr Specialist , Quality Assurance** + Requires a Bachelor's or higher… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management ... We have an exciting and unique opportunity for a senior level medical writer ( Senior Manager, Medical...or projects. You will represent Medical Writing on relevant product , project, and/or regulatory submissions teams; providing specialist… more
- Danaher Corporation (San Jose, CA)
- …to fast-track research breakthroughs, leading to earlier diagnoses and safer drug treatments. We're a leading life science solutions provider of high-performance ... and tactical solutions-oriented legal services? We are currently seeking a Senior Counsel who will join an inclusive, service-oriented, legal and compliance… more