- 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs-Labeling, Associate Director is responsible for ensuring that ... and a brighter future to the world. **How you will contribute:** + The Associate Director , GRA Labeling Compliance, is responsible for the strategic and… more
- Sumitomo Pharma (Trenton, NJ)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs** . The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she...and the ability to contribute to the development and writing of a regulatory strategy document in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Taiho Oncology (Princeton, NJ)
- …and execution, analysis and reporting of data, and authoring/review of scientific and regulatory documents. The Associate Director of Biostatistics will have ... Associate Director , Biostatistics Princeton, NJ, USA...clinical data + Create/author statistical sections of scientific and/or regulatory documents + Manage external biostatisticians to ensure quality… 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
- Bristol Myers Squibb (Princeton, NJ)
- …Responsibilities: + Develops expertise beyond biostatistics by researching medical literature, regulatory and HTA documents to develop an understanding of the ... clinical, regulatory /HTA and commercial climate. + Contributes to preparation of...data manipulation, graphing & simulation. + Great interpersonal, communication, writing and organizational skills. + Expertise in statistical/clinical trials… 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- …(CRU)- Myeloma Research Team and indirectly report to the CRU Central - Associate Director of Clinical Research Operations. The successful candidate will work ... of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to...+ The candidate will work closely with the CRU Associate Director of Operations to develop and… more