- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ Interact with clinical investigators and thought leaders + Work with internal regulatory affairs team and other ethical guidelines relevant to the ... Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs . + Provide clinical expertise and input for … more
- Bully Pulpit Interactive (San Francisco, CA)
- …Zurich. We apply our unique expertise across strategic communications, public affairs , research, and digital marketing to create sophisticated and customized ... The Impact You Will Make We are seeking a seasoned, outcomes-driven Managing Director to lead and expand our Strategic Communications practice for a portfolio of… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Abbott (Temecula, CA)
- …making. + Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs , R&D, clinical, operations QA, and ensures alignment ... To ensure Design Control activities are robust in ensuring the highest quality and reliability of products from concept through manufacturing. Ensures that… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all… more
- Stanford University (Stanford, CA)
- …heart and lung transplantation and to assume the role of founding Director of Pediatric Thoracic Transplantation as an Assistant Professor, Clinical Assistant ... This individual will work closely, in a leadership role, with the medical director of heart transplantation and the medical director of lung transplantation,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to help transform innovations to life-changing medicines for patients. The Senior Director , RWE Inflammation Product Lead reports to the Executive Director , ... use of RWE at the global level. The Senior Director , RWE Product Lead will oversee a team of...the appropriate level of resources to ensure the timeliness, quality , and utility of RWE required by internal and… more
- Abbott (Alameda, CA)
- …in a scientific, medical, or technical discipline. * Minimum 8-10 years of experience in Quality Systems, Regulatory Affairs , or Quality Assurance within ... with FDA, ISO 13485, EU MDR, and other global regulatory standards. The Director will provide strategic...documentation for non-returned product cases. * Establish and maintain quality metrics to enhance process efficiency and data reporting.… more
- Ascendis Pharma (Palo Alto, CA)
- …PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits + ... employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the Director...PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to… more
- University of Southern California (Los Angeles, CA)
- …the appropriate parties and that changes are implemented to maintain compliance and quality . + Collaborates with internal stakeholders on regulatory and policy ... the nation's largest classical music provider. We are hiring an Assistant Director of Health Government Relations to join the department's Health Policy Governments… more