- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for ... strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …exciting and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory ... content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's… more
- IQVIA (Parsippany, NJ)
- …or combination of education, training and experience * Extensive experience in regulatory and/or technical writing * Advanced negotiating and influencing skills ... Job Overview Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is… more
- Bristol Myers Squibb (Summit, NJ)
- …cell therapies enabling global regulatory approval and launches. The ** Associate Director , Program Management** plays an important role in organizing, ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Associate Director , Program Management, Global Operations (Inline Asset… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director , Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... the world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty...global communications programming in support of clinical data and regulatory milestones as well as pipeline; 2) supporting development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. - CRO / Vendor ... Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …to clinical studies or programs with the guidance of senior level statisticians (ie, Associate Director or higher) which includes, but is not limited to, ... but not limited to, strategic planning, study designs, data analyses, and regulatory interactions. You'll be expected to have extensive knowledge about statistical… more