- Gilead Sciences, Inc. (Foster City, CA)
- …deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate across Gilead ... Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …upstream process technology transfers to CDMOs, including documentation review, gap analysis , and risk assessment. + Provide expert technical oversight of upstream ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification ... + Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs. + Drive strategies for… more
- Ascendis Pharma (Palo Alto, CA)
- …Senior Clinical Scientist is involved in the design, monitoring, and data analysis of the Company's late-phase clinical trials studying growth hormone, parathyroid ... to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions + Maintain up-to-date knowledge of relevant science, medical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in-depth knowledge of industry practices. + Solid working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and GDP. + Able to apply ... + Masters' Degree and Eight Years' Experience; OR + PhD and Two Years' Experience + Experience in pharmaceutical...Works on problems of moderate to advanced complexity where analysis of situations or data requires an evaluation of… more
- Stanford University (Stanford, CA)
- …while maintaining their accuracy and completeness. + Determine data collection and analysis requirements. Design and customize research reports based on data in the ... database. Oversee and monitor regulatory compliance for the utilization of the data. +...or surveys. + Test prototype statistical software and data analysis notebooks and participate in reviewing statistical software and… more
- UNUM (Sacramento, CA)
- …Medicine and Rehabilitation. This position is responsible for providing expert medical analysis of claims files (or underwriting applications) across Unum US product ... services to the Benefits Center. The Medical Consultant adheres to current regulatory , claim process, and internal workflow standards as set forth in the… more
- Medtronic (Los Angeles, CA)
- …evidence for clinical and/or pre-clinical product portfolio decisions, marketing, regulatory agency submissions, and product reimbursement strategies. + Conducts ... including, epidemiology studies, registries, observational studies, modeling, surveys, and meta- analysis . + Collaborates with the Clinical Development team to ensure… more
- DataVisor (Mountain View, CA)
- …frameworks, including model documentation, version control, validation, monitoring, and regulatory compliance alignment. AI-Powered Data Analysis and insight ... language models (LLMs), with a focus on using AI to accelerate data analysis , result interpretation, and fraud signal discovery. This is a hands-on leadership role… more
- Jet Propulsion Laboratory (Pasadena, CA)
- …Project Controls Section provides project cost and schedule control, planning, and analysis support to JPL's programs and projects. As an Institutional Program ... and establishing training recommendations to help improve schedule planning, analysis , ands performance on JPL Projects. **Key Responsibilities:** + **Technique… more