- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD ... the compound. + Implements clinical development programs, including: + Co-authoring global clinical development plans with all practical elements. + Leading… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Documentation Global Head **Location** : Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... for the development of document management strategies and flawless execution of Clinical Documentation deliverables. We are an innovative global healthcare… more
- Cytel (Trenton, NJ)
- Principal Clinical Data Manager Our commitment to...Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the ... development. Who Are You? We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data … more
- Sumitomo Pharma (Trenton, NJ)
- …safety, and compliance with GCP standards . + Develop and execute corporate clinical strategy for global development projects in Oncology + Monitor ... trends and scientific advancements within Oncology. + Interpret clinical data , evaluate safety and efficacy, and... and present findings clearly. + Significant experience with global clinical trials and regulatory process. +… more
- Sanofi Group (Morristown, NJ)
- …on the IEGP. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, ... clinical studies, RWEs and claims database analyses + In-depth knowledge of clinical trial design, biostatistics, and data analysis. + Proficient in… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible for providing a ... the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV.... Integrity:** Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality… more
- Sanofi Group (Morristown, NJ)
- … regulatory labeling requirements, particularly US and EU. + Ability to interpret clinical data and protocols with respect to regulatory labeling implications. + ... The Associate Director collaborates closely with cross-functional teams, including Global Regulatory Affairs, Clinical Development, Safety, and Medical… more
- Sumitomo Pharma (Trenton, NJ)
- …of the drug development process + Experience as a member of a local or global development team + Current on industry standards and trends + Familiarity and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Sanofi Group (Morristown, NJ)
- … clinical utility and scientific validity + Collaborate with data scientists and biostatisticians to design methodologically sound approaches for matching ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Bristol Myers Squibb (Princeton, NJ)
- …for clinical programs, develop reports and publications on translational data generated to support asset development and contribute to regulatory submissions. ... landscape and competitive scenarios + Strong scientific background with understanding of clinical , translational, and mechanistic data with proven track record… more
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