- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that audit results are communicated, and… more
- Amgen (Thousand Oaks, CA)
- …you'll help make a lasting impact on the lives of patients as we research , manufacture, and deliver innovative medicines to help people live longer, fuller happier ... process technology transfer and other technical documents. **Process Validation & Regulatory Support** + Development of validation plans and supports execution of… more
- US Tech Solutions (San Bruno, CA)
- …Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified Bodies, etc.), and regulatory audits. ... providing training and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release,… more
- AbbVie (South San Francisco, CA)
- …with scientific research trials, SOPs, etc.). + Experience interacting with regulatory agencies. + Experience in leading NDA, BLA, and or CTD submission ... team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on… more
- Abbott (Milpitas, CA)
- …phases of design. Collaborates with upstream partners (product managers, market research , UX designers, etc.) to streamline development and de-risks development ... + Plans and conducts worldwide customer, competitive, and software industry research to identify and prioritize usability improvement possibilities and solutions +… more
- Wells Fargo (Los Angeles, CA)
- …and merger consequences + Performing comprehensive and in-depth company and industry research + Preparing presentations and other materials for clients + Conducting ... research , participating in strategic planning and assisting in the...to statutory disqualification. Successful candidates must also meet ongoing regulatory requirements including additional screening and are required to… more
- Edwards Lifesciences (Los Angeles, CA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... Intra-Procedural, Post-Procedural Case Support** + Represent the Clinical Affairs Research Team during clinical trial cases with investigating physicians, hospital… more
- WSP USA (Roseville, CA)
- …public and private sector. Tasks may include assisting with the research , design, concept development, planning, and construction of facilities, roads, buildings, ... and construction. + Perform professional civil engineering work and conduct research and inspections of proposed and existing site conditions, resources, building,… more
- Danaher Corporation (Vista, CA)
- …In Situ Hybridization (ISH). + Advanced degree in Science, Healthcare, or Regulatory /Clinical Affairs + Professional certification in Clinical Research (eg, ... team of clinical study managers, driving strategic operational execution, ensuring regulatory compliance, and achieving key milestones for critical clinical studies… more
- WSP USA (San Jose, CA)
- …Act, etc. + Highly proficient analytical skills and prior experience with research techniques, local/regional ecology, habitats, and applicable regulatory zone. ... executing project work, permitting strategy, environmental impact assessments, and regulatory compliance, including project budgets, tracking hours and expenses, and… more