- Gilead Sciences, Inc. (Foster City, CA)
- …regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership ... improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals while contributing to the overall quality… more
- Guidehouse (Los Angeles, CA)
- …work experience excluding internships, co-ops, or fellowships; **Or** Completing a PhD degree in electrical or power systems engineering from an accredited ... (1+) plus year directly relevant Graduate Assistant/Research work with relevant PhD research/course work experience + **Managing Consultant -** Bachelor's degree in… more
- Stanford University (Stanford, CA)
- …the decades-long investment the department has made into meeting regulatory qualifications, implementing training, and adhering to high-performance standards for ... and clinicians. The launch of a new Biomedical Physics (BMP) PhD Program in 2022 marked the first PhD training program at Stanford to be housed within a clinical… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …digital health * Oversee and coordinate clinical research operations, including regulatory compliance and participant engagement * Analyze and interpret complex ... datasets from wearable devices, sensors, and clinical assessments * Collaborate with multidisciplinary teams including clinicians, engineers, and researchers * Mentor students and junior research staff * Assist in developing research protocols and managing… more
- Merck (South San Francisco, CA)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) + Provide clinical… more
- BeOne Medicines (San Carlos, CA)
- …quantitative assessments of pipeline molecules, integrating clinical, commercial, and regulatory factors to evaluate potential success. + Develop predictive models ... + Develop valuation models for pipeline molecules, integrating scientific, clinical, regulatory , and market access considerations. + Support strategic planning for… more
- Sumitomo Pharma (Sacramento, CA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- BeOne Medicines (Emeryville, CA)
- …and non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program management, ... and reconcile all payment information. + Interfaces with cross-functional colleagues in Regulatory , Quality, and Clinical Supply Chain. + colleagues as needed to… more
- Bristol Myers Squibb (San Diego, CA)
- …activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives ... Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed **Skills/Knowledge… more
- Stanford University (Stanford, CA)
- …Manager (Biostatistician 2) to join the Department of Genetics to map the regulatory wiring of the human genome to discover genetic mechanisms of disease. The ... a successful candidate could join immediately. Lab overview: DNA regulatory elements in the human genome, which harbor thousands...functions - if only we could map the complex regulatory wiring that connects 2 million regulatory … more