- BeOne Medicines (Emeryville, 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
- BeOne Medicines (Emeryville, CA)
- …functionally. Understands Annex 13 and PSF. + Works collaboratively with global and regional study teams to ensure that proper root cause assessments, corrective ... and implementation of risk identification and management strategy for clinical studies and other regulated drug development...processes, procedures, regulations and tools intended for use in clinical study conduct and other regulated drug… more
- Pfizer (South San Francisco, CA)
- …pharmaceutical industry or related fields required; experience in medical affairs programs, clinical study operations and / or medical communication operations. ... precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. + The Medical Strategy Management Senior Project Manager… more
- Abbott (San Francisco, CA)
- …support to Cardiac Rhythm Team in the following areas: + Sales support + Regional training seminars + Clinical studies /data collection + Trouble Shooting ... + ** Clinical Interface** : Acts as a senior clinical interface between the medical community...product and technical knowledge, trends, and players while providing regional case coverage. + **Training and Education** : Develops,… more
- BeOne Medicines (Emeryville, CA)
- …and study levels + Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core ... , for early to late-stage medicines development across global clinical operations (GCO). Good understanding of global, regional...across study teams and programs to accelerate study execution. + Partners with global clinical … more
- Abbott (Alameda, CA)
- …APAC regions to initiate and execute Health Economic analyses, Outcomes Research/RWE studies and Market Access initiatives to maximize and protect patient access ... for scientific soundness of activities, and ensure outcomes aligned with Global and regional payer needs. They will partner with a worldwide community of well… 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)
- …methodological advances and trends to ensure best approaches are used in relevant studies and evaluations. + Engage key clinical , methodologic, and TA experts ... LIVE including leading and supporting Gilead Sponsored and Collaborative studies , and serving as the Team Lead for the...(ET). The ideal candidate will have previous experience in clinical and operational research, and significant knowledge in one… more
- BeOne Medicines (Emeryville, 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
- BeOne Medicines (Emeryville, 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