- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ... teams for regulations impacting Clinical , Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and...Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... strategy, model, and operations as a key member of Clinical Quality program leadership team. **What you...Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical… more
- Bausch + Lomb (Boston, MA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, ... GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...purposes. **POSITION REQUIREMENTS** **:** + Strong knowledge of Good Clinical Practices ( GCP ), clinical trials… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Clinical Research Director , I and I, Pulmonology **Location:** Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The ... be critical in helping our teams accelerate progress. The Clinical Research Director (CRD), Immunology & Inflammation...clinical study protocol + Oversee the execution of clinical studies in compliance with internal SOPs, GCP… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees ... Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join...industry environment + Strong knowledge of current global Good Clinical Practice ( GCP ) for designing, recording and… more
- Sanofi Group (Cambridge, MA)
- …for ensuring all evidence generation activities comply with regulatory requirements, Good Clinical Practice ( GCP ), and company policies. + In charge of ... **Job title** : Global Medical Director , Evidence Generation - Innovation & Partnerships **Location:**...in patient and scientific knowledge and insights to improve clinical care. We do this by generating and curating… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... improvement + Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Overseeing implementation of related processes and technologies in compliance with quality standards (including ICH GCP , local regulations, and Takeda SOPs). ... and driving collaboration with other stakeholders (peer function, cross-functions, quality ), ensuring cross-functional alignment of the process, and escalating… more
- Takeda Pharmaceuticals (Boston, MA)
- …study management team members in order to deliver operational consistency and high quality support across clinical trial programs. + Provide guidance and ... the execution of studies in a matrix management structure to ensure compliance with quality standards (including ICH GCP , local regulations and Takeda SOPs). +… more
- Pfizer (Cambridge, MA)
- **POSITION SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for ... program. + Responsible for scientific oversight, data integrity and quality of the clinical trial(s). + Represent...of the sponsor leading studies + Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity… more