- BeOne Medicines (San Mateo, CA)
- **General Description:** As the Regional Strategic Feasibility Lead within Global Clinical Operations (GCO), you will play a vital role in collaboration with the ... global strategic feasibility lead, study teams, and cross-functional stakeholders...study), ensuring standardization of data, tools, and processes for quality decision-making. **Data-driven Feasibility Recommendations:** + Combine and integrate… more
- BeOne Medicines (San Mateo, CA)
- …of global , regional, and country landscape and regulatory requirements. Drive high- quality strategic feasibility/site identification assessments ... risk assessment with therapeutic knowledge balanced with data analytics and interpretation. The Global Strategic Feasibility Analytics Lead supports the Head of … more
- Nura Bio (South San Francisco, CA)
- …experience in both large and small pharmaceutical organizations. *In-depth knowledge of global regulatory requirements and guidelines. *Proven track record of ... of the central, peripheral, and ocular nervous system. The VP/ Head of Regulatory Affairs will be a...regulatory agencies, including the FDA, EMA, and other global health authorities, to facilitate the approval process. *Lead… more
- Abbott (Alameda, CA)
- …impact on people's lives. **The Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative ... validation, verification, risk management, cybersecurity, and documentation practices. + ** Global Regulatory Strategy:** Develop and execute regulatory… more
- Genentech (South San Francisco, CA)
- …working within a global network, with a deep understanding of regulatory and quality requirements, and the ability to align bioprocess technologies ... highest standards, reinforcing Roche's leadership in the biologics sector. **The Opportunity** The Global Head of Biologics Technology leads Roche's global … more
- Grant Thornton (San Jose, CA)
- Grant Thornton is seeking a Global Head of Product Innovation (Sr. Director) to join the team. Approved office locations can be found below. Role Summary We are ... a visionary and strategic leader to serve as the Global Head of Product Innovation. This executive...+ Standardize processes and governance to ensure consistency and quality across regions. + Optimize global resource… more
- Genentech (South San Francisco, CA)
- …to deliver high quality bioanalytical methods and data in compliance with global regulatory and industry standards with a lean organizational footprint and ... regulatory and industry standards in support of our global portfolio. The Head of BAS will...high quality delivery of key data for global regulatory documents such as INDs/CTAs and… more
- Ascendis Pharma (Palo Alto, CA)
- …develop their skills. The Director, Head , ICSR Management Team reports to the Head , Global PV Operations within the Global Patient Safety (GPS) ... organization. Under the direction of the Head , Global PV Operations, the Director, ICSR...Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance… more
- Saildrone (Alameda, CA)
- …Headquartered in Alameda, CA, with offices in Washington, DC, and global deployment hubs, Saildrone operates missions worldwide. Join a fast-moving, mission-driven ... data turns into intelligence, and intelligence drives action. The Role The Head of Software will lead Saildrone's software engineering organization, overseeing all… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework, and of global biopharmaceutical manufacturing sector ... aspirations. Join Gilead and help create possible, together. **Job Description** ** Head of Manufacturing Strategy and Operations, Foster City, CA** Gilead Sciences… more
- AbbVie (South San Francisco, CA)
- …In-depth knowledge and understanding in application of standard business procedures ( regulatory guidance, global regulations, ethical issues assoc/iated with ... team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on… more
- Renesas (San Jose, CA)
- …customers with MCUs, MPUs, analog, power & connectivity solutions. In this environment, the Global Head of Customer Quality must ensure that Renesas not ... trends, improvement plans, and risk factors to customers and internal leadership. 9. ** Global Quality Organization & Governance** 10. Build and lead a… more
- Ascendis Pharma (Palo Alto, CA)
- …for employees to grow and develop their skills. The Program Safety Lead reports to Head of Global Medical Safety Science. Under the direction of Head ... with Head of GPS Medical Science and Head of Global GPS Operations in activities...Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance… more
- Ascendis Pharma (Palo Alto, CA)
- …their skills. The Associate Director, ICSR Management Team reports to the Director, Head , ICSR Management Team within the Global Patient Safety (GPS) ... PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …GCP and E-System Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program. Reporting to the Head of GVP Audits, the ... role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape … more
- Ascendis Pharma (Palo Alto, CA)
- …to help cover a leave of absence. The ICSR Management Lead reports to the Head , ICSR Management within the Global Patient Safety (GPS) organization. Under the ... direction of the Head , ICSR Management, is responsible for all assigned ICSR...Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Working… more
- Kelly Services (South San Francisco, CA)
- …events(AOSE) and individual case comments for ICSRs. + Maintain knowledge of global regulatory authority regulations including FDA. + Represent and advise ... equity **Position Overview:** The Director, Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Product Lead reports to the Executive Director, RWE Therapeutic Area (TA) Head -Inflammation and is accountable for the development and execution of the RWE ... as the key RWE subject matter expert within the Global Development Team (GDT) for the product(s) and all...the appropriate level of resources to ensure the timeliness, quality , and utility of RWE required by internal and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Inflammation will ... (TA), and oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions in the TA. The ideal candidate will have a proven… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to ... exciting opportunity to immediately gain more direct experience with regulatory submissions? Join our Biostatistics team and take on...This is a site based role located at our global headquarters in Foster City, CA. **Key Responsibilities:** +… more
