- Bristol Myers Squibb (Princeton, NJ)
- …after clinical proof-of-concept studies, including but not limited to regulatory submissions and life-cycle management. Translational disease strategies in ... expertise in disease biology, patient segmentation and therapeutic resistance to inform science driven strategies for the development of the GI Oncology pipeline.… more
- Merck (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions. Under the general scientific and administrative direction of ... subject matter expertise, a strong understanding of drug commercialization and the regulatory landscape. **In this role, the successful candidate will be responsible… more
- Merck (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... benchtop science of preclinical discovery into compounds ready for assessment...(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) + Provide… more
- Bristol Myers Squibb (Madison, NJ)
- …we are inspired by a single vision - transforming patients' lives through science . In oncology, hematology, immunology and cardiovascular disease - and one of the ... pipeline assets and sits at the interface between discovery and translational science and clinical drug development. The Director, Early Clinical Development role… more
- Organon & Co. (Jersey City, NJ)
- …Audit and approve DHF (Design History File) documentation for applicable regulatory filings, clinical supply, development, and design transfer qualification. + ... Ensure compliance with regulatory and Organon requirements. Evaluate deficiencies and assess impact...preferred Education/Experience minimum requirement: + A bachelor's degree in ( Science or Engineering or associated fields) with a minimum… more
- Merck (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... supervision in Late Development Statistics. + Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research Laboratories… more
- Sanofi Group (Morristown, NJ)
- …group at extended clinical team meetings and may attend external meetings with regulatory agencies and key opinion leaders. We are an innovative global healthcare ... and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a...(CROs) + Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for… more
- J&J Family of Companies (Raritan, NJ)
- …Innovative Medicine is informed and inspired by patients, whose insights fuel our science -based advancements. Visionaries like you work on teams that save lives by ... in collaboration with cross-functional team members (eg, Statistics, Pharmacometrics, Clinical, Regulatory etc.) on all clinical pharmacology aspects of the assigned… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to assist in the preparation and review of global nonclinical regulatory facing documents including IND's, marketing applications, health authority briefing ... and review and understand nonclinical study reports. Experience in global regulatory practices and guidance's for nonclinical drug development and submissions is… more
- New Jersey Institute of Technology (Newark, NJ)
- …Professor of Practice - Pharmaceutical Chemistry Department: Chemistry and Environmental Science Reports To: Chair, Department of Chemistry & Environmental ... Science Position Type: Faculty Position Summary: The Department of...- Expertise in curriculum development, program assessment, and industry regulatory practices/compliance. Bargaining Unit: PSA FLSA: Exempt Full-Time Special… more