- Xybion Corporation (Princeton, NJ)
- …safe. Through our intelligently designed low-code software platforms, we digitize drug research and development, laboratory testing, regulatory approvals, and ... global SaaS company that helps enterprise life sciences organizations accelerate new drug development into approved medicines that save lives and keep employees… more
- Merck (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products. We are seeking a highly motivated candidate for the position of ... Principal Scientist (R5) focused on developing parenteral drug products across a range of modalities (small molecule, peptides, proteins, antibody- drug … more
- J&J Family of Companies (Raritan, NJ)
- …R is required. + Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical ... internal SAS programmers, clinical trial managers, and personnel from regulatory affairs, medical writing, and other disciplines as needed. **Qualifications**… more
- Fujifilm (Trenton, NJ)
- …established policies and procedures. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- PSEG (Newark, NJ)
- …This position will report to, and is responsible for working with, the VP Regulatory , Deputy General Counsel & RTO Strategy Officer to develop strategy, shape rules ... position will serve as a back-up for the VP Regulatory , Deputy General Counsel & RTO Strategy Officer in...be different from normal operations. For all roles, PSEG's drug and alcohol testing program includes pre-employment testing, testing… more
- Organon & Co. (Jersey City, NJ)
- …labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of ... labeling documents for company products, including Core, US and supporting country regulatory affiliates for consistency of labeling documents around the world. +… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an… more
- Merck (Rahway, NJ)
- …scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for approval of drug /vaccine products; Prior experiences with ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Sumitomo Pharma (Trenton, NJ)
- …programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and ... oversee clinical trial strategies, ensuring alignment with corporate objectives and regulatory requirements for SMPA and the future oncology initiatives. + Medical… more
- Lilly (Branchburg, NJ)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and ... support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. **Responsibilities:** + Assess differences in current… more