- 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
- 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
- Merck (Rahway, NJ)
- **Job Description** The Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills,… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …our team. The ideal candidate will have a strong background in scientific writing , medical terminology, and a deep understanding of HIV and virology research. The ... Viral Hepatitis/Liver Disease research, including new therapies, treatments, and regulatory changes, and communicate relevant information to internal teams.… more
- Merck (Rahway, NJ)
- …, Operations, Non-clinical, Clinical, and other functional areas + Experience with regulatory submissions including writing / review of regulatory ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… 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