- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- **SUMMARY:** We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical ... review and analysis to support appropriate safety interpretation and benefit-risk assessment. As a Senior Manager of Global Patient Safety a typical day… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities with ... key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Clinical Scientist Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a...other departments; Member of the Clinical Study Team and Global Clinical SubTeam + Develops/maintains understanding of therapeutic disease… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle ... contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization's GxP… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and skills to ... The ** Senior Clinical Study Lead** (CSL) is expected to...considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. **This position manages multiple biological developmental… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …scientific integrity and interpretation of study data of a clinical development program. The Senior Manager leads in a matrix environment as part of a ... The Manager , Clinical Sciences, Hematology leads in the development,...following: + Member of the Clinical Study Team and Global Clinical sub-team + Contributes to program team meetings,… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary The Senior Manager of RWE Biostatistics is a member of cross-functional ... + Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic...+ Ability to: - learn regulatory requirements & clinical trial design, data analysis and interpretation, - work successfully… more
- IQVIA (Parsippany, NJ)
- Job Overview Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing ... The PMA works in partnership with the Project Leader (PL)/Clinical Project Manager (CPM) providing support with project management activities to mitigate risk,… more