- Sanofi Group (Morristown, NJ)
- …to shape the future of medicine with us? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... a dynamic interactive Preclinical Safety group that spans all aspects of the drug development value chain providing toxicology and safety pharmacology expertise as a… more
- Merck (Rahway, NJ)
- …the regional regulatory and business environment, including: + API and Drug Product development needs + GMP compliance in commercial manufacturing + Data ... broad deliverables including, but not limited to, API and Drug Product analytical problem-solving and optimization, trace impurity quantitation, characterization… more
- J&J Family of Companies (New Brunswick, NJ)
- …Develop data requirements to meet RWE objectives. This will include both regulatory -grade and observational research data sets. Be responsible for partnering with ... and implementing RWE plans to support clinical/research objectives throughout the drug development lifecycle. + Work closely with individual clinical teams as… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of drugs and unmet medical needs. + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with ... position requires deep understanding of all aspects of the drug development process from early clinical stages to post...with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible… more
- Sanofi Group (Morristown, NJ)
- …secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, ... This critical role: + Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI to launch, and… more
- System One (Park Ridge, NJ)
- …direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through ... testing when necessary. Your expertise will directly impact product safety, regulatory success, and speed-to-market for critical medical devices and healthcare… more
- Merck (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be ... purpose of generating early clinical development plan and Investigational New Drug applications + Developing of clinical development strategies for investigational… more
- AbbVie (Florham Park, NJ)
- …of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership for design, analysis and reporting ... function/department on project team(s) to provide statistical input to compound/ drug development and drive alignment with functional management. Partner with… more
- Fujifilm (Trenton, NJ)
- …safety policies and procedures. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... 13485 standard requirements and all other applicable laws, regulations, and standards. **Qualifications:** Experience: + Minimum of 3 to 5 years of field sales experience or clinical experience desired. + Knowledge of and experience in GI/pulmonary flexible… more
- Fujifilm (Trenton, NJ)
- …other duties as assigned. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... standard requirements and all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** + BA/BS… more