- BeiGene (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
- BeiGene (Emeryville, CA)
- …degree in life sciences with + Experience in clinical operations as clinical research associate, clinical study manager, or compliance required + ... **General Description:** The Senior Learning Business Partner (LBP) will be responsible...and meets regional needs. + Collaborate with regional cross-functional teams within Clinical Operations to… more
- Pfizer (San Francisco, CA)
- …document, study report, and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency (within ... in program-wide functions on Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams… more
- BeiGene (Emeryville, CA)
- …including, but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... **General Description** + The Senior Director, Global Regulatory Lead will be responsible...the review of global submission documents in support of clinical trials and marketing applications, and their amendments to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …involved with the development and validation of IVDs (eg, Study Management, Clinical , Biomarkers) and presents to senior leadership as required. + Develops, ... the translational discovery, development, and validation of biomarkers in clinical studies . You will provide operational and...FDA and IDEs. Provide inputs on key development documents, clinical protocols, study reports, IBs, INDs, CTAs,… more
- Abbott (Alameda, CA)
- …EMEA region 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
- Gilead Sciences, Inc. (Foster City, CA)
- …on cross-functional/cross- regional sub-teams across development (eg, Global Development Team, Study Management, etc.) and present to senior leadership as ... closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and cross-functional stakeholders to communicate a clear… more
- BeiGene (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