- BeOne Medicines (Emeryville, CA)
- …executes Crisis Management response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature of response, best course of ... response + Leads responses and contributes to formal response provided to regulatory agencies, reviews draft response, and manages approval of response + Actively… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced ... supply management as well as changes in the regulatory landscape that would impact clinical supply...Experience Requirements:** Requires a Bachelor's degree preferably in a science -related field 8+ Years with BA/ BS OR 6+… more
- Ascendis Pharma (Palo Alto, CA)
- …specifications. + Generate or validate tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions. + Support ... knowledge of CDISC standards, including SDTM and ADaM. + Understanding of the clinical drug development process and regulatory requirements. + Proficiency in SAS… more
- Amgen (Thousand Oaks, CA)
- …longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities ... and governance of standardized data collection practices across our clinical programs. In this vital role, you will build...and reviews to ensure alignment with evolving study and regulatory needs. + Manage governance processes for evaluating and… more
- Kelly Services (Thousand Oaks, CA)
- …that may be available to you as a member of the Kelly Talent Community. Why Kelly (R) Science & Clinical ? Kelly Science & Clinical is your connection to ... harvesting under IACUC and AAALAC guidelines. Maintain accurate and regulatory -compliant records of all animal procedures. Coordinate biological sample logistics… more
- Amgen (Thousand Oaks, CA)
- …+ 5 or more years of Rare Disease experience + 3 or more years of clinical research experience and/or basic science combined with clinical teaching and ... product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory , and medical affairs They will… more
- Merck (South San Francisco, CA)
- …n/a **Required Skills:** Clinical Development, Clinical Pharmacology, Clinical Trial Designs, Data Modeling, Data Science , Data Visualization, Drug ... cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and ophthalmologic… more
- Stanford University (Stanford, CA)
- …to their patients. Our faculty is committed to the highest level of basic and clinical research in Obstetric and Gynecologic science , and our staff is dedicated ... of women and people of all genders across the lifespan. As one of 19 Clinical departments and 12 Basic Science departments within the School of Medicine (SoM),… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle ... ensure submission compliance for Health Authority (HA) acceptance. + Support Regulatory Affairs to deliver high quality and consistent maintenance health authority… more
- Bristol Myers Squibb (Brisbane, CA)
- …and institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Provides guidance ... clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry… more