- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical ** is seeking a Regulatory Affairs Manager for a direct-hire position at a cutting-edge client in South San Francisco, CA . If ... next step in your career, trust **The Experts at Hiring Experts.** **Manager, Regulatory Affairs ** At Veracyte, we offer exciting career opportunities for those… more
- BeOne Medicines (San Mateo, CA)
- …team. The ideal candidate will have a strong background in research , clinical development, regulatory affairs , and safety, with a particular focus ... on R&D. + Proven expertise and understanding of research , clinical development, regulatory affairs , and safety processes, workflows and analytics. +… more
- Ascendis Pharma (Palo Alto, CA)
- …partner effectively with multiple functions, including Clinical development, Research , Product Development, Medical Affairs , Commercial and Quality. Strong ... we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned… more
- Abbott (Santa Clara, CA)
- …experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. + ... software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite... review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical … more
- Gilead Sciences, Inc. (Foster City, CA)
- …submission and approval process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Responsible for development ... and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining … more
- Abbott (Santa Clara, CA)
- …experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. + ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ... prevention. The ideal candidate will have previous experience in clinical and operational research , and significant knowledge...proposals + Act as a resource of Phase 4 research within Medical Affairs and with x-functional… more
- Abbott (Pleasanton, CA)
- … regulatory guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory process ... female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site in… more
- J&J Family of Companies (Santa Clara, CA)
- …Development, Global Strategic Marketing, US marketing, Medical Affairs , Clinical Research , Regional HEMA & Marketing, Regulatory Affairs , Health Care ... Function:** Market Access **Job Sub** **Function:** Health Economics Outcomes Research **Job Category:** Professional **All Job Posting Locations:** Santa Clara,… more
- Abbott (Alameda, CA)
- …decisions about how to improve energy, lose weight or enhance athletic performance. The Clinical Affairs Manager will manage teams within the Medical Affairs ... responsibilities. **What You'll Work On** + As the Manager of the Clinical Affairs Sub-Function, oversees the strategy implementation and operations for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …years of experience in clinical research and development (R&D) or regulatory affairs within the pharmaceutical or biotechnology industry. + At least 1 ... documents, including timeline reviews. + Collaborate with cross-functional teams (eg, Clinical Research , Biometrics, Virology) to ensure accuracy, completeness,… more
- J&J Family of Companies (Santa Clara, CA)
- …is _strongly preferred_ . + Experience leading in medical affairs , clinical development or related roles in research /medical device industry is _strongly ... with an initial focus on Robotic Bronchoscopy. This role involves overseeing clinical research , ensuring compliance with medical regulations, supporting medical… more
- BeOne Medicines (San Mateo, CA)
- …patient communities. **Cross-Functional Collaboration** + Partner closely with R&D, Medical Affairs , Clinical Development, Regulatory , Global Commercial, ... embedding the patient voice across the product lifecycle - from early research and development, regulatory engagement, commercialization, access and throughout… more
- Gilead Sciences, Inc. (Foster City, CA)
- …meetings, representing the US perspective and needs in working groups with respective Clinical Development, Global Medical Affairs , US Commercial, US Government ... Affairs and Policy, US Public Affairs , US Regulatory , and US legal and...legal and compliance + Represent US data gaps and research needs related to viral hepatitis, PBC and Covid-19.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Medical Affairs , Real World Evidence, Health Economics and Outcomes Research , Project Management, Regulatory , Biometrics, Clinical Research ... Description** This position is a member of the Medical Affairs Research (MAR) Leadership Team and will...teams + Plays a lead role in representing Medical Affairs Clinical Operations within cross-functional organizational initiatives… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ... (ET). The ideal candidate will have previous experience in clinical and operational research , and significant knowledge...**Specific Job Responsibilities** + Lead development of the Medical Affairs Research - LIVE strategic approach for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in US across, Commercial, Medical Affairs , Value & Access, Government Affairs , Clinical Development, as well as coordinating with colleagues across Public ... create possible, together. **Job Description** Gilead Sciences, Inc. is a research -based biopharmaceutical company founded in 1987. Together we deliver life-saving… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US medical ... the therapy area expert for internal and external stakeholders. Provides expert clinical and scientific support to internal teams in the Scientific Innovation Office… more
- Edwards Lifesciences (Oakland, CA)
- …effective collaboration across senior leadership stakeholders, including clinical , regulatory , marketing, health economics and outcomes research teams ... PhD, MD) in a related field, plus professional leadership experience in the clinical , research , or healthcare industry + Extensive experience in evidence… more
- Abbott (Santa Clara, CA)
- …management, clinical operations, clinical science, biostatistics, data management, regulatory affairs , medical affairs as well as external stake ... colleagues serve people in more than 160 countries. **Director, Clinical Research ** Our business purpose is to...interact with multiple internal cross-functional teams, including R&D, medical affairs , regulatory affairs and finance… more