- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations,… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of...implementing the execution and evolution of Eisai's Compliance Monitoring Program . This role will oversee both live and transactional… more
- Insmed Incorporated (NJ)
- …required; PharmD or PhD strongly preferred.Minimum of 5 years clinical drug development experience.Strong medical writing and presentation skills.Understanding ... for the future of science, we're in. Are you?About the Role:The Associate Director , Clinical Research Scientist will support and work predominately with the Medical… more
- Insmed Incorporated (San Diego, CA)
- …industry, preferably with 5+ years of gene therapy orphan (rare) drug development experienceKnowledge or experience of neurology and/or ophthalmology ... cross-functional teams and senior leadership, as neededCollaborate with Clinical Development , Clinical Operations, CMC, QA/QC, Nonclinical, Program Management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …leads to ensure harmonization and alignment across all functions and sites.Support the development of the GMP Compliance program related to clinical/ commercial ... will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, alignment and… more
- Insmed Incorporated (NJ)
- …and Program Management to drive proactive Quality input into development programs.Provide Quality oversight of contract development and manufacturing ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for... CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology… more
- Eisai, Inc (Nutley, NJ)
- …Directives, US FDA, PMDA, ICH, and National regulations).In the current times, drug development is going through a significant transformation with ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …procedures for AE/SAE case processing, including data collection, assignment, coding ( drug /event), narrative development , and case assessment Ensure alignment ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ability to define clear translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development required- Deep ... areas centered around rare diseases and immune disorders. Summary: The Director , Translational Pathology will work across the Translational Science matrix to… more
- Insmed Incorporated (NJ)
- …of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support.Extensive understanding of ... various teams.Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide… more
