- Kelly Services (Sunnyvale, CA)
- …we pioneer progress in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global Market Protection **Workplace:** Remote ... Kelly(R) Science & Clinical is seeking a Senior Regulatory Affairs Specialist...for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position offers the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is ... global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership...degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and… more
- Stryker (San Jose, CA)
- …We are currently seeking a ** Senior Staff Regulatory ... improvement in functions. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist**...supporting new product development, assessing design changes to determine global regulatory impact, and completing actions to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …include but are not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs , Legal and Commercial) ... a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this individual will… more
- Gilead Sciences, Inc. (Foster City, CA)
- …include, but are not limited to the following:** + Under the supervision of a Global Virology Regulatory Affairs liaison, the intern will work with various ... members in the Gilead Foster City team to support regulatory submissions in the United States and potentially other...college + Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Responsibilities will include, but are not limited to the following:** + Assist the Global Inflammation Regulatory Affairs Liaison team with projects to ... department goals and objectives. + Interns will assist with regulatory submissions and activities, including but not limited to...college + Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and...of current global and regional trends in regulatory affairs and ability to assess the… more
- Stryker (Fremont, CA)
- … Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior leadership. + Ensures strategic alliances with physicians, key ... external/internal sources and partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing to obtain … more
- Deloitte (San Jose, CA)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... a digitally enabled, equitable future of health As a Senior Manager in our AI & Data team are...+ Veeva RIM and/or QMS implementation + Understanding of regulatory data and regulatory filing requirements +… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Affairs , Community Engagement and Advocacy and engages colleagues across Public Affairs ' global centers of expertise and global therapeutic area ... the care of patients with life-threatening diseases. **Associate Director, Public Affairs , US HIV Prevention Communications** Reporting to the Director, US HIV… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of the PBC USMA strategic and tactical plans in collaboration with the broader US Medical Affairs team and the Global Medical Affairs team. Candidate must be ... areas, including Commercial, Marketing, Clinical Research, Pharmacovigilance and Epidemiology, Public Affairs , Government Affairs , Regulatory , and Legal +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …US HIV Prevention Strategy Lead and will work directly with the US and Global teams. The Medical Affairs Associate Director, HIV Prevention, will report directly ... teams to review, update, and provide insight into Medical Affairs slide decks and local and global ...trainings + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Medical Writing is a global , dynamic, and diverse team residing within Global Regulatory Affairs . We work collaboratively to advance the strategy ... scope and estimate required review time. Escalates to more senior team members if special document strategy is needed....work experience in the biopharma industry, eg, clinical R&D, regulatory affairs , quality, or other related discipline.… more
- Stanford University (Stanford, CA)
- Director of Academic Affairs & HR Strategies **School of Medicine, Stanford, California, United States** **New** Administration Post Date 1 day ago Requisition # ... at the School of Medicine. The Director for Academic Affairs & HR Strategies will provide strategic direction and...film screening, or listen to a renowned author or global leader speak. * **A caring culture.** We provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB** **DESCRIPTION** + ... than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES**… more
- Ascendis Pharma (Palo Alto, CA)
- …and Development, Medical Information, and Scientific Alignment. As a member of the Global Medical Affairs team, the Senior Manager, Scientific Alignment ... for employees to grow and develop their skills. Scientific Affairs is a key division within Global ...as a member of the US Legal, Medical, and Regulatory (LMR) review committee, reviewing US Commercial and Medical… more
- Lucile Packard Children's Hospital Stanford (Palo Alto, CA)
- …domains of quality, safety, patient experience, engagement and wellness, and financial strength. Regulatory Affairs : + Leads regulatory compliance with and ... throughout the greater Bay Area, and beyond. As the Senior Associate Dean for Maternal and Child Health, partners...Staff and Chief Compliance Officer to ensure conformity with regulatory requirements. Support for Medical Staff Affairs :… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the entire product lifecycle with input from Research, Clinical Development, Regulatory Affairs , Quality, Pharmaceutical Development & Manufacturing, Legal and ... US FDA, EMA, PMDA) + Established reputation as a senior leader in the global pharmacovigilance ecosystem...including academic medicine and industry experience in development, medical affairs and/or regulatory affairs . **Gilead… more
- Abbott (Santa Clara, CA)
- …methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and ... position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations. **What You'll Work On**...of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D, Clinical R&D, Sales and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …key global functional partners including Information Technology, Medical Affairs , Legal, Regulatory , Pharmaceutical Development and Manufacturing. They will ... HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases. Reporting to the Senior Vice President, Global Commercial Strategy & Operations (GCSO),… more