- GRAIL (Menlo Park, CA)
- …companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities for one or multiple diagnostic ... management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA -regulated environment, with a strong track record of EDC system… more
- Schwan's Company (Beaumont, CA)
- …isn't just a job, it's a seat at the table! We are hiring a Sr. Manufacturing Manager within our large Asian foods plant in Beaumont, CA! If you've got a passion for ... adjusts daily work schedule as needed to meet production requirements + Manages, trains, and develops subordinates to include...+ Prior experience in food manufacturing with exposure to USDA/ FDA regulations strongly preferred + Ability to read and… more
- United Therapeutics (CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... can showcase your knowledge and expertise. The Senior/Therapy Access Manager (TAM) is a customer-facing role that will be...San Diego, Las Vegas and Salt Lake City Minimum Requirements + TAM - Bachelor's Degree with 6+ years… more
- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Manager of Biostatistics to serve as trial statistician for one or more clinical ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Deloitte (San Jose, CA)
- …data platforms. Our delivery models are tailored to meet each client's unique requirements . The Team Our AI & Data practice offers comprehensive solutions for ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in… more
- Edwards Lifesciences (San Francisco, CA)
- …Our other star player? You! IHFM has achieved a significant milestone and received FDA approval for our Cordella PA Sensor. Join us as we commercialize this ... revolutionary heart failure management system! As the Area Sales Manager at IHFM, you will play a pioneering role...and diplomacy + Adhere to all company rules and requirements (eg, pandemic protocols, Environmental Health & Safety rules)… more
- Abbott (San Jose, CA)
- …making travel plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements , company policies, operating procedures, ... to restore their health and get on with their lives. The Territory Manager position is a sales opportunity in the CardioMEMS business responsible for achieving… more
- Gilead Sciences, Inc. (Foster City, CA)
- …external operational contractor support, including advising on OPDP submission requirements for accelerated approval and launch submissions, as applicable. You ... You may train cross-functional partners and teams on promotional material submission requirements . You will assist or serve as the Promotional Review Committee (PRC)… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …of technical guidelines to assure execution of regulatory strategies and requirements . This is a fully remote role. **Primary responsibilities:** + Develops ... for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory … more
- Insight Global (San Diego, CA)
- …and evaluating systems and procedures that are cost[1]effective and meet user requirements . Plans and executes unit integration and acceptance testing; and may ... create specifications for systems to meet business requirements . Provides consultation to users in the area of automated systems. We are a company committed to… more