- BeiGene (San Mateo, CA)
- …the regional Clinical Operations Americas GCP compliance team. The Director GCP Compliance collaborates effectively with stakeholders within the ... continents. For more information, please visit www.beigene.com. **General Description:** The Director , GCP Compliance , Americas provides quality guidance,… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company to inspire you and empower you to shine? Join us as an Associate Director , GCP Compliance based remotely reporting to the Director , ... + Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …on quality compliance activities. + Provide guidance and support to GCP , PV Health Authority inspections including logistics. + Present insights to the health ... and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and … more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Associate Director , Education and Quality Assurance (Abramson Cancer Center) Job Profile Title ... Associate Director , Clinical Research Quality Job Description Summary The Abramson...oversight that is aligned with ICH Good Clinical Practice ( GCP ) to ensure ACC CRU inspection readiness comply with… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Director , GxP Quality Assurance and Compliance ** to join us in our mission to discover and develop drugs that improve human health ... CAPAs, product label review, risk management, and eQMS (MasterControl) + Ensure compliance , in collaboration with relevant SMEs and senior leaders, with all… more
- Kedrion Biopharma (Atlanta, GA)
- …+ Design and interpret clinical trial data, supporting program objectives. + Ensure compliance with protocols, company SOPs, ICH GCP , and regulatory standards. + ... ** + Adhere to company policies and ethical codes of conduct. + Maintain compliance with GCP , clinical trial regulations, and company SOPs. + Uphold… more
- Teva Pharmaceuticals (West Chester, PA)
- …in the Global Clinical Quality department, serves a critical role to ensure compliance with global Good Clinical Practice ( GCP ) guidance, laws, and regulations, ... Associate Director , Global Clinical Quality Date: Nov 21, 2024...Follow-up on inspection commitments. + Lead to resolution complex compliance issues that may affect multiple projects. + Independently… more
- e CancerCare (Fresno, CA)
- Purpose: The Director , Clinical Trials & Research, for CCARE Physicians, PC, is responsible and accountable for the daily operations and management of staff, of the ... the finance department, the overall financial activities of the department. Assures compliance with all regulatory requirements and standards of good practice (… more
- SMBC (New York, NY)
- …a competitive portfolio of benefits to its employees. **Role Description** The Director of Cloud Security Architecture will ensure bank's cloud infrastructures are ... surfacing, driving down, and reporting on cloud security issues across our AWS, GCP , and Azure environments. This role is responsible for identifying secure cloud… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient ... We are seeking an Associate Director to join out Oncology Clinical Development department....Proficient knowledge of clinical development process, regulatory requirements and ICH/ GCP guidelines. Does this sound like you? Apply now… more
- Pfizer (Collegeville, PA)
- …the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and ... Quality Review Team (QRT) + Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation. **Major… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …safety; Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + Ensures consistent ... We are seeking a Director to join our Clinical Development team. The...extensive knowledge of clinical development process, regulatory requirements and ICH/ GCP guidelines. We need a proven track record in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …ratio of a therapeutic candidate in CDP-defined indication + Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines + Supports communications ... The Medical Director of Clinical Sciences should be a qualified...team running clinical trials in the CDP according to GCP . Work in close collaboration with Clinical Program Operations… more
- Penn Medicine (Plainsboro, NJ)
- …team meetings, disease site and/or discipline group meetings, and ongoing protocol training/ compliance meetings. The Associate Director will assist in the ... day. Are you living your life's work? We are hiring for an Associate Director Oncology Research Operations to join our Cancer Services team at Penn Medicine… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Quality Assurance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... suffering from immunological diseases. Position Summary: We seek an Associate Director , Quality Assurance to join an experienced, fast-paced and collaborative team.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the Specimen Management product development and overall business objectives. The Director assures compliance with applicable regulations regarding all pre-market ... become your best self. Become a **maker** **of possible** with us. The Director , Clinical Operations is responsible for the development and management of the… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Director of R&D Quality Systems, Strategy, and Excellence (Strategy & Innovation) is responsible for leading initiatives that ... that improve quality outcomes and enhance decision-making processes. The Associate Director will drive cultural change and system modernization, ensuring that… more
- Johns Hopkins University (Baltimore, MD)
- …IDEs in accordance with the JHU governing guideline. The IND/IDE Program Director will develop and maintain all operational functions that support IND/IDE activities ... Unit, Office of Research Administration, Departmental/Divisional leadership and JHU/JHHS compliance monitoring programs; serves as a liaison with external partners… more
- Actalent (Piscataway, NJ)
- …medical aspects of our clinical studies. This role ensures subject safety, site compliance with protocols and ICH- GCP requirements, and maintains the scientific ... Director of Medical Monitoring We are seeking a...and emergencies. + Review protocol deviations and ensure medical compliance . + Train teams on therapeutic areas, protocols, and… more
- Sanofi Group (Cambridge, MA)
- …management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations ... **Job Title:** Clinical Research Director **Location** : Cambridge, MA **About the Job**...all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice ( GCP ), applicable… more
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