- BeiGene (San Mateo, CA)
- …study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an...meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional … more
- Vera Therapeutics (Brisbane, CA)
- …Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory aspects of clinical studies in early-to-late development to create high quality ... Title: Senior Manager, Clinical Regulatory Location: Brisbane,...for submission, ensuring complete regulatory content that meets current regional requirements * Represent clinical Regulatory Affairs… more
- Medtronic (Menlo Park, CA)
- …and therapies + Collaborates with clinical research organization relative to clinical studies and physician research + Commitment to personal continued ... therapies provide a competitive advantage. + Disseminate competitive information to regional teams + Delivers competitive technical and clinical training… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is currently recruiting for a Senior Regulatory Affairs Specialist for a 2-year contract opportunity with a leading molecular ... New Product Development **Pay rate:** $50-55/hour **Company:** Kelly(R) Science & Clinical **Overview** The Regulatory Affairs Senior Specialist II, NPD… more
- BeiGene (San Mateo, CA)
- …+ Works cross-functionally to ensure proper planning of inclusive clinical study protocols, providing feasibility feedback on regional site selection and ... **General Description:** Reporting to the Head of Americas, Clinical Operations, the Director - Clinical ...to hold composure, be engaged and present adeptly to senior BeiGene leadership when needed + Scientific acumen -… more
- BeiGene (San Mateo, CA)
- …ensuring internal partnership across the organization. The candidate will report to the Senior Regional Director, Solid Tumor - GI, within Medical Affairs. As ... . The **Field Medical Director (FMD)** will support BeOne Medicines pre- clinical and clinical pipeline development by coordinating external collaborations,… more
- Stanford Health Care (Palo Alto, CA)
- …of clinical results as appropriate; and present at local, regional and national research meetings/conferences as appropriate. + Reports on activities and ... which serves patients across the world. Its robust network of seven clinical sites staffed by Stanford's team of renowned surgical oncologists, medical oncologists,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development organization, which includes responsibility for medical safety aspects of clinical studies such as protocol design, benefit-risk assessment, signal ... and leverage their experience to represent Patient Safety in discussions with senior leadership and Executive Management. The GHPS oversees patient safety governance… more
- BeiGene (San Mateo, CA)
- …including, but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... affairs departmental and cross-functional influence and acts as an advisor/liaison to senior management and project teams to plan, evaluate and recommend regulatory… more
- BeiGene (San Mateo, CA)
- …including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational… more
- BeiGene (San Mateo, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to...the US and Canada. + Supports the NA hematology regional team to negotiate with the US FDA as… more