- BeiGene (Emeryville, CA)
- **Position Summary:** The Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. ... best practice submission processes. The SD will successfully lead the Global Regulatory Affairs organization in identifying and guiding process optimization and… more
- Abbott (Alameda, CA)
- …for Abbott's diabetes care business. + Partner with various stakeholders including regulatory affairs , operations, quality, R&D, HR, government affairs , ... many countries around the world. **What You'll Work On** + Work closely with the Director , Public Affairs to set and drive global PR strategy and storytelling… more
- Sutter Health (Emeryville, CA)
- …and procedures Ensures complete and accurate GMEC membership Strategy/Planning Works with the Sr . Director , Academic Affairs to support and execute the ... + Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance. + Proficient with Microsoft Word, PowerPoint and Excel. +… more
- BeiGene (Emeryville, CA)
- …are met while leveraging expedited pathways where appropriate.** **The individual has regulatory affairs departmental and cross-functional influence and acts as ... **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- BeiGene (Emeryville, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- BeiGene (Emeryville, CA)
- **General Description:** The Senior Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important ... approved BeiGene products + Actively leads Development and Medical Affairs product teams in the identification of, and handling...depending on the program / portfolio being led. The Senior Medical Director serves as Product Safety… more
- BeiGene (Emeryville, CA)
- …**Working knowledge of drug/biologics development, clinical research, study design, biostatistics, and regulatory affairs (eg, FDA and ICH guidelines for various ... **General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international … more
- BeiGene (Emeryville, CA)
- …position will have oversight for supporting functional areas such as Regulatory Affairs (CMC, Strategy, Project Management), Quality/Manufacturing, Clinical, and ... work. + Serve as a primary lead on global programs within R&D and Global Regulatory Affairs , including the ability to lead both strategy, program management and… more
- Olympus Corporation of the Americas (San Jose, CA)
- …our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA) ... purpose and our core values by staying **True to Life.** **Job Description** The Director of Quality, San Jose Operations is responsible for GMP Operations of the… more
- BeiGene (Emeryville, CA)
- …and collaboration with functional area peers including Drug Safety, Quality Assurance and Regulatory Affairs , as well as thought leaders in order to meet ... The Associate Director (AD) Clinical Study Management leads both indirect...contracts and/or work order changes prior to submission to senior management for approval. The AD CSM establishes and… more
- Stryker (San Jose, CA)
- …teams with a sense of urgency + Conducts periodic Quality review with senior leadership within the division and responsible for providing data /state of ... affairs of product quality in the field + Actively...ensuring the quality and compliance of all products to Regulatory Standards within FDA and international guidelines. + Designs,… more
- Abbott (Pleasanton, CA)
- …and cross-functional teams. This FCS position works closely with Global Clinical Affairs (GCA) including the Medical Director and Program Management, Global ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Senior Field Clinical Specialist** **Working at Abbott** At Abbott, you can do… more