- Parexel (Sacramento, CA)
- …this is the ideal role.** We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior ... - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/ Clinical Trial Design, Clinical Strategy,… more
- GRAIL (Menlo Park, CA)
- …+ Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture ... with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements. + Manages all clinical operational aspects of a clinical trial from… more
- Terumo Neuro (Aliso Viejo, CA)
- …team leadership, and strong cross-functional collaboration with Medical Affairs, PACE, Regulatory , Clinical Safety, and Data Management. Ensure high standards ... business priorities. + Act as a key liaison between Clinical Operations and departments such as Regulatory ...between Clinical Operations and departments such as Regulatory Affairs, Quality, R&D, PACE, R&D, and Medical Affairs… more
- BeOne Medicines (Emeryville, CA)
- …without compromising quality + Strong working knowledge of ICH Guidelines, Good Clinical Practices, and Regulatory Agency requirements + Proven ability to ... vision and mission. Leveraging deep therapeutic and functional area expertise, the Clinical Operations Lead in Biotech Unit is accountable for the planning, budget,… more
- Pfizer (San Diego, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, ... Experience working with and solid understanding of related disciplines, eg, Clinical Operations, Data Management, Safety, Biostatistics, Regulatory , Study… more
- CEDARS-SINAI (Beverly Hills, CA)
- …of staff, in a clinical research setting. Familiarity with clinical research operations, including regulatory compliance, study coordination, and staff ... Responsible for directing and managing a specified program within the clinical research operations unit, department, or division. Provides leadership, guidance and… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …throughout EHR and provides for seamless delivery of patient care. The Clinical Informaticist must understand regulatory requirements including but not limited ... care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a… more
- Parexel (Sacramento, CA)
- …and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing ... analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need… more
- BeOne Medicines (Emeryville, CA)
- …of the job:** + Lead quantitative assessments of pipeline molecules, integrating clinical , commercial, and regulatory factors to evaluate potential success. + ... assets. + Develop valuation models for pipeline molecules, integrating scientific, clinical , regulatory , and market access considerations. + Support strategic… more
- Stanford Health Care (Palo Alto, CA)
- …with members of the Stanford Health Care leadership team to support clinical , quality, regulatory compliance, information systems, fiscal, and research goals ... quality patient care in alignment with hospital policies and applicable state/federal regulatory requirements (such as CMS, OPTN/UNOS, and TJC). This role supports… more
