- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that foster a reputation for outstanding quality, collaboration, rigor, and follow-through. Collaborate with the Head Global RD PV QA and the Head Global ... function heads for effective decision-making, and present to the Global Head of RD, PV QA/Vice President...to ongoing activities. Produce and deliver accurate reports and documentation related to Global QA activities in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …levels are met.Lead the process for reviewing and assessing KQIs regularly, preparing management documentation for the QA Head , and ensuring that any gaps or ... or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... for correction, with a copy to manager and department head .Provide timeline to address issues and verify that issues...systemAdvise speaker bureau vendor to provide all back up documentation ( ie F&B receipt, AV, sign in sheet,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... management activities within US Patient Safety Team. Relationship Reports to the Head of NNI Patient Safety, with cross-functional working relationships within Case… more
- Merck & Co. (Rahway, NJ)
- …solid-oral small molecules and includes pre-approval regulatory strategy and submissions ( global clinical and marketing applications such as IND, CTA, ... and traditional solid-oral small molecule products and including pre-approval regulatory work ( global clinical and marketing applications such as IND, CTA, NDA,… 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 ... be critical in helping our teams accelerate progress. The Clinical Documentation Head is responsible...management strategies and flawless execution of Clinical Documentation deliverables. We are an innovative global … more
- Sanofi Group (Morristown, NJ)
- …alignment with, but not limited to, commercial/marketing, public affairs, finance, clinical , and global teams during planning and execution. _Medical ... and Key Results (OKRs) and impact metrics in close coordination with SEI Head , and global /local leadership + Proactively identify and mitigate potential issues… more
- Sanofi Group (Morristown, NJ)
- …with members of the CTT and Project Team, as well as colleagues within Clinical Documentation . + must provide dedicated scientific authoring expertise to ensure ... regarding both the project as a whole, and individual clinical studies. **Our Team:** Global Medical writing...mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with… more
- Merck (Rahway, NJ)
- …solid-oral small molecules and includes pre-approval regulatory strategy and submissions ( global clinical and marketing applications such as IND, CTA, ... and traditional solid-oral small molecule products and including pre-approval regulatory work ( global clinical and marketing applications such as IND, CTA, NDA,… more
- Sanofi Group (Morristown, NJ)
- …Medical Program Lead (MPL) will, in collaboration with the relevant Medical Head , lead the strategic direction and operational execution of the medical brand ... policies/SOPs/guidance and required external regulations and guidelines. We are an innovative global healthcare company with a focus on immunology that extends to… more
- Bristol Myers Squibb (Summit, NJ)
- …apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of ... to include an understanding of biology, chemistry, medical or clinical practices. + Pre-requisites: Prior experience in Manufacturing and/or scientific/engineering… more
- Bayer (Whippany, NJ)
- …for pull through of the medical and Franchise strategy by translating the Global , Regional, and Local medical plans and imperatives into implementable HCP engagement ... high level of technical and scientific expertise and broad knowledge of clinical and business issues impacting the Bayer business environment and landscape; +… more
