- System One (Plainsboro, NJ)
- …managing and executing clinical trials to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards. The role ... of the electronic Trial Master File (eTMF), supporting inspection readiness and regulatory compliance. + Maintain relevant data within Clinical Trial Management… more
- Bristol Myers Squibb (Princeton, NJ)
- …in late-stage development, life cycle management as well as all global clinical development components of regulatory documents. Preferred locations are New ... experts in oncology and immuno- oncology drug development * Managing all clinical components of regulatory documents, including filings for initial registration… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …cross-functional management, interpersonal and problem-solving skills. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP ... We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development,… more
- J&J Family of Companies (Raritan, NJ)
- …partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs, clinical pharmacology, health economics, and the disease ... evaluation and develops the strategy and the content for regulatory documents. + Works with senior clinical ...for regulatory documents. + Works with senior clinical staff, establishes credible relationships with external stakeholders such… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- … studies, review and interpret clinical trial data, provide input into clinical study and regulatory communications and reports, and contribute to ... results. + Author, review, and/or provide strategic input into: 1. Clinical sections of regulatory documents including, IND submissions, annual updates,… more
- J&J Family of Companies (Raritan, NJ)
- …design and endpoints . Working with functional partner leadership (eg, Global Clinical Operations (GCO), Regulatory , Global Medical Safety) to achieve common ... products including Excel and Word + Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and… more
- Bristol Myers Squibb (Princeton, NJ)
- …protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents + Conduct investigator meetings and ... trial investigators and thought leaders + Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and… more
- Sanofi Group (Morristown, NJ)
- …PharmD, or medically qualified with: + Min 15 years of experience working in clinical development and/or regulatory affairs + Min 10 years of leading an ... **Job Title:** Clinical Documentation Global Head **Location** : Cambridge, MA,...revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates… more
- Bristol Myers Squibb (Madison, NJ)
- …activities + Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (eg, IB, DSUR, regulatory ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function which… more
- Actalent (New Brunswick, NJ)
- …and as a Clinical Research Coordinator (CRC). + Strong understanding of clinical operations and regulatory compliance. + Bachelor's Degree in a science ... comprises 70 employees with diverse skill sets, including CRC, Regulatory Affairs, and Clinical Research Managers. We foster a collaborative culture where you… more