- Ascendis Pharma (Palo Alto, CA)
- … Global Patient Safety (GPS) organization. Under the direction of the Head, Global PV Operations, the Director , ICSR Management Team is responsible for the ... for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head,...Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- **Job Description Summary** The Director , Quality Engineering - WW IPD is responsible for developing and leading the global Design Center Quality function for ... are designed and manufactured in compliance with applicable industry and regulatory standards and meet customer expectations for safety and effectiveness. Reporting… more
- J&J Family of Companies (Irvine, CA)
- …at https://www.jnj.com/medtech Johnson and Johnson is currently seeking a ** Director , Medical Affairs, Electrophysiology** located **in Irvine, CA.** Atrial ... from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating...and is as challenging as it is rewarding. The Director will have medical affairs responsibility in providing therapeutic… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Global Compliance Operations team and reports directly to the Senior Director , Global Head of Ethics and Compliance Training and Communications. The ... ethics and compliance training and communications strategy, ensuring alignment with the global objectives, legal and regulatory requirements. + Ensure all… more
- BeOne Medicines (San Mateo, CA)
- …Lead the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... is preferred. + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than 10%… more
- AbbVie (San Francisco, CA)
- …will be based on qualifications listed below. Purpose: The Scientific/Medical Director , Medical Affairs provides specialist medical and scientific strategic and ... scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for oversight… more
- Amgen (Thousand Oaks, CA)
- …area to a range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development ... advance clinical programs, as well as the overall product strategy. The Executive Director will report into the Vice President, Global Clinical Development.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or external reviews including ensuring alignment with Gilead business needs and regulatory requirements. + Stay current with evolving global PV regulations ... audits, in the biopharma or related industry. + Proficiency in pharmacovigilance regulatory requirements ( Global ) is a must. + Expert-level experience working… more
- Vera Therapeutics (Brisbane, CA)
- …aspects of the biopharmaceutical industry, biologic development is preferred. * Experience in Regulatory and global filings required. * High level of accuracy ... Title: Associate Director , Program Management Location: Brisbane, California About Us:...lead late-stage development Program, Atacicept, in alignment with Vera's Regulatory strategy and our commitment to health authorities globally.… more
- Sumitomo Pharma (Sacramento, CA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Patient & HUB Operations, Rare Disease** . The Director , Patient… more