- Merck (Rahway, NJ)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of 8 years of relevant … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 4 or More Years of relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content and complexities and ... around rare diseases and immune disorders. **Responsibilities** + Ensure global regulatory plans support a precision medicine approach eg integrated drug/diagnostic … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Liasions to ensure sucessful implementation of CDx and data collection + Supports Regulatory affairs in providing content and providing review of documents ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Liasions to ensure successful implementation of CDx and data collection - Supports Regulatory affairs in providing content and providing review of documents ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs , Companion Diagnostics/ Device Laboratories Vendors/ CROs **_Leadership/ ... around rare diseases and immune disorders. **Summary** The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever… more