- Novo Nordisk Inc. (San Francisco, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... trials in all stages of development. Incumbents have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position… more
- 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 (Emeryville, 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
- 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
- AbbVie (San Francisco, CA)
- …one aspect of Drug Development (eg, pre- clinical research , clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls (CMC)). ... Include: + Proactively search for, identify, and evaluate potential opportunities ( research collaboration, in-licensing preclinical and clinical assets, platform… 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
- 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
- BeOne Medicines (Emeryville, 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
- Grifols Shared Services North America, Inc (San Francisco, 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
- 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
- Edwards Lifesciences (San Francisco, 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
- Edwards Lifesciences (San Francisco, CA)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... our inspiring journey. We are searching for a **Senior Clinical Research Monitor** to join Edwards Transcatheter...clinical trial/study safety in accordance with protocols, Good Clinical Practices (GCP), and regulatory requirements. +… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Proficient with Microsoft Suite. ... **Qualifications:** + BS degree in life sciences or equivalent with minimum 7 years of clinical research experience + Must have 4 to 5+ years of relevant… more
- Abbott (Alameda, CA)
- …study site staff, and clinical management. + Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs + Proficient with Microsoft Suite The ... in life sciences preferred or equivalent with minimum one (1) year of clinical research experience, or combination of appropriate education and experience. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents ... regulatory strategies, processes, standards, practices, efficiencies and capabilities. + Represents Regulatory Affairs and may serve as Regional Lead or… more
