- BeOne Medicines (San Mateo, CA)
- …associated with Work Instructions (WI), Standard Operating Procedures (SOP), and Global Standards (GS) through the electronic Learning Management System ... and reconciliation for depot storage as needed. + Supports on Storage Insurance data calculation and reporting. + Coordinate or directly organize site to site… more
- AbbVie (Irvine, CA)
- …literature and clinical guidelines, and assists in the development/approval of Data on File in accordance with established policies and practice standards . ... Call Center staff, and managing the development, approval, and maintenance of global and region-specific medical/technical global content (GC) response documents… more
- Genentech (South San Francisco, CA)
- …modeling to enable quantitative translation of literature, in vitro and preclinical data to inform the drug design, clinical dosing regimen and ... QSP/QST models to enable translation of in vitro and preclinical pharmacology / toxicology data for informing the drug design and clinical dosing regimen. + The… more
- ThermoFisher Scientific (Carlsbad, CA)
- …Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards , Laboratory Setting, Office, Some degree of PPE (Personal Protective ... position within the Instrument Services Business Unit and will support Clinical Accounts identified within the Strategic Accounts Program. This role focuses… more
- BeOne Medicines (San Mateo, CA)
- …environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions ... including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory… more
- Actalent (Sacramento, CA)
- Clinical Credentialing, Privileging, & Enrollment Supervisor Overview The Credentialing & Privileging Supervisor oversees the full lifecycle of provider ... credentialing, recredentialing, and privileging for all licensed, certified, and other clinical staff. This role ensures compliance with California regulations, HRSA… more
- Sumitomo Pharma (Sacramento, CA)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing patient ... escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/ global (if applicable) regulatory requirements. **Key ... may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured,...(eg, Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... executing regulatory strategies across the global drug development lifecycle. This role blends deep regulatory expertise with advanced project management skills,… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting, ... influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle. This role combines deep regulatory expertise… more