- BeOne Medicines (San Mateo, CA)
- …the regional strategic feasibility teams. Close partnership with global program & study management team for design and delivery of the studies, for early to ... global, regional, and country landscape and regulatory requirements. Drive high- quality strategic feasibility/site identification assessments based on Standard of… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** This position will be responsible for the management of clinical outsourcing needs in support of BeOne's current and planned clinical trials ... be responsible for clinical study budget estimation and budget management during the study life cycle, engaging the business,...needs, such as accruals, project budgets, etc. + Ensures quality oversight of suppliers by: + Partners with suppliers… more
- United Therapeutics (Sacramento, CA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... regulatory experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area of study...of study + 8+ years of project or people management experience + Must have written an IND and… more
- Bristol Myers Squibb (San Diego, CA)
- …to late-stage clinical development, their approval and life cycle management . Early-stage translational development activities enable rational determination of ... of BMS's therapies post-clinical proof-of-concept, including registrations and life-cycle management . Translational disease strategies in Alzheimer's /Neurological Diseases are… more
- Sumitomo Pharma (Sacramento, CA)
- …provide additional expertise in the + undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and ... Programming Organization. + Create/acquire tools to improve programming efficiency or quality . + Establish monitoring of data transfers for ongoing trials to… more
- Acxiom (Sacramento, CA)
- …format. + Support strategy development in areas such as: + Customer data management , platforms, and governance. + Data quality , taxonomy, and metadata models. ... + Identity strategies and consent/preference management . + Activation through clean rooms, orchestration, and measurement. + Early-stage AI use cases and analytics… more
- BeOne Medicines (San Mateo, CA)
- …CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-approval applications. + Develop ... product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development of...documents, CTD M2 and M3 sections, and life cycle management . + Educational background in scientific disciplines and expertise… more
- Gilead Sciences, Inc. (Foster City, CA)
- …that will improve the lives of patients with life-threatening illnesses worldwide. As an Associate Director of Quality Assurance, you are responsible for: ... **Job** **Responsibilities:** * Serve as a lead quality engineer for medical device combination product development projects,...with a strong emphasis on design control and risk management activities. * Oversee design control, risk management… more
- BeOne Medicines (San Mateo, CA)
- …hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data, developing ... design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. + Collaborates with the statistical programming staff… more
- Gilead Sciences, Inc. (Foster City, CA)
- …deadlines in a fast-paced environment while maintaining a high level of quality and accuracy. + Work closely with key stakeholders, including researchers, ... and transparency standards. + Proficiency in Microsoft Office suite and reference management software + Excellent written and verbal communication skills, with the… more
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