- BeOne Medicines (Emeryville, CA)
- …and documents. + Designs and conducts quality issue trending, analysis and review activities to proactively identify broader issues and/or patterns within GCO ... + Bachelor's Degree with minimum of 10 years of experience in pharmaceutical or biotechnology drug development, preferably in a relevant field such as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional team + Provide scientific and clinical ... /products + Lead or support clinical development contributions in the preparation/ review of regulatory documents, investigator brochures, and development plans +… more
- BeOne Medicines (San Mateo, CA)
- …The Manager, Regulatory Advertising and Promotion will be responsible for the review and approval of promotional materials for assigned marketed products in ... approved labeling. **Essential Functions of the Job:** + Performs regulatory review for promotional materials in conformance with local regulatory requirements and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and management (eg, scope change log and budget / cost impact reporting). + Review project cost estimates to confirm that defined project scope has been fully ... with expected project controls governance processes (eg, funding, sourcing/procurement, contract review , invoice review and approval, change order approval). +… more
- Cedars-Sinai (Los Angeles, CA)
- …agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). **What are the Primary Duties & Responsibilities?** + ... Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol… more
- GRAIL (Menlo Park, CA)
- …United Kingdom. It is supported by leading global investors and pharmaceutical , technology, and healthcare companies. For more information, please visit grail.com ... and Form 144's as required within Workiva. + Adhere to internal and external review and filing deadlines, including tracking and communication of status. + Review… more
- BeOne Medicines (Emeryville, CA)
- …support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed * Perform study-specific training with ... for use by monitoring team to assist in efficient review of study data * Perform Serious Adverse Event...of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry * Excellent communication and interpersonal… more
- US Tech Solutions (San Jose, CA)
- …ROM estimates, construction schedules, and funding justification presentations. Be able to review and comment on new mechanical systems designs produced by MEP ... design firms under contract to WD. Review existing mechanical systems designs as required when troubleshooting issues which may require an engineered solution. Make… more
- Parexel (San Francisco, CA)
- …Science, OR equivalent industry experience. + 7+ years experience in pharmaceutical /biotech clinical data management / Biometrics (clinical trial data and/or Real ... ensure high-quality, compliant data. + Use surveillance tools to review data at an aggregate level, identifying patterns or...stakeholders as part of the Risk Management Plan. + Review and analyze metrics to derive meaningful summaries of… more
- Bio-Techne (San Marcos, CA)
- …including new products, Supplier Corrective Action Reports, change notifications, etc. Review SCARs sent back from suppliers to assess corrective actions. Conduct ... implementation. . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re-validation… more