- IQVIA (Anaheim, CA)
- …a specific CDM task (eg, Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where ... ability to apply them in practice. + Knowledge of Good Clinical Practices and relevant regulatory guidelines. + Comprehensive understanding of clinical drug… more
- University of Southern California (Los Angeles, CA)
- …Research Administrator (CRA) preferred Required Skills: + Strong understanding of clinical trial methodologies and regulatory requirements + Proficiency in ... support our growing and dynamic research department. Reporting to the Senior Clinical Administrative Director II, and working closely with the KSOM Office of… more
- BeOne Medicines (Emeryville, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory , molecular diagnostics, and ... The Executive Medical Director will support BeOne Clinical and Medical assets within the Hematology franchise...franchise by successful development of early and late phase clinical development strategies and deliverables in partnership across the… more
- LA Care Health Plan (Los Angeles, CA)
- …audits for non- clinical grievance and appeal case documentation. Ensure A&G Non- Clinical staff is following all Regulatory guidelines, internal P&Ps, Desktop ... a consistent and accurate manner. This position will focus on quality review of non- clinical grievance and appeals cases for all line of business (LOB) to identify… more
- Actalent (Irvine, CA)
- …using imaging tools such as echo, CT, and fluoroscopy. + Provide on-site support for clinical cases. + Assist in regulatory and FDA study planning. + Create and ... Job Title: Clinical Development Engineer Job Description A medical device...transcatheter therapy for valvular heart disease is seeking a Clinical Development Engineer to support early human use and… more
- Actalent (Irvine, CA)
- …using imaging tools such as echo, CT, and fluoroscopy. + Provide on-site support for clinical cases. + Assist in regulatory and FDA study planning. + Create and ... Job Title: Clinical Development Engineer Job Description Join a pioneering...therapy for valvular heart disease. We are seeking a Clinical Development Engineer to support early human use and… more
- BeOne Medicines (Emeryville, CA)
- …priorities. + Ensures cross functional strategic input is embedded in the clinical development plans and regulatory strategy including trial design, endpoints, ... for a single asset across its entire life cycle - from early clinical development to late-stage pivotal studies, then through commercial launch and market access,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development: IND-enabling studies, translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with ... PM'ing early phase biopharma programs, working with Research and Clinical Development teams + Deep understanding of all aspects...FDA/EMA guidance for preclinical and early clinical phases. + CMC awareness: Understanding of drug substance/product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including INDs, NDAs, and other global filings. + **Collaborate cross-functionally** with Regulatory , Quality, Clinical , and Manufacturing teams to align on ... product development programs, ensuring alignment with design control and regulatory requirements. + **Ensure high-quality documentation** , including design… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred. + Minimum of 7+ years ... and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay...closely with other key functions, including regional medical leads, clinical development, global value and real-world evidence, US and… more