- Regeneron Pharmaceuticals (Warren, NJ)
- …study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If ... leadership and contributes to the programming support for processing data from clinical studies. Project requirements will be identified according to a Statistical… more
- Novo Nordisk (Plainsboro, NJ)
- …including ED&AA, IT, Ethics and Compliance, Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. ... Externally, this role interacts with and manages various vendors. Essential Functions + Leadership and Management + Skilled communicator and collaborator with influence across functions + Strong business acumen; trusted advisor on AI/GenAI implementation and… more
- Merck (Rahway, NJ)
- …datasets following CDISC standards. Generate tables, listings, and graphics required for clinical trial decision-making, regulatory requests, clinical study ... the guidance of a senior-level programmer supporting early-phase oncology clinical trials. Collaborate with other programming colleagues and biostatisticians and/or… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred. + Minimum of 7+ years ... and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay...closely with other key functions, including regional medical leads, clinical development, global value and real-world evidence, US and… more
- Rastelli Foods Group (Logan Township, NJ)
- …Instructions for Use, and equipment manuals meet all required legal, regulatory , clinical , marketing, packaging, manufacturing (contract and internal) and ... Family to Yours" Roles and Responsibilities: + Verify label accuracy and regulatory performance. + Perform quality check upon receiving materials. + Ensure safety… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be ... + ** Regulatory Authority Engagement:** Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any… more
- AristaCare (New Brunswick, NJ)
- …communication to enhance patient and family satisfaction, adherence to center's clinical systems and regulatory compliance. Requirements; + Must possess, ... of a population of patients within an assigned area, unit or clinical function. The position conducts the nursing process, assessment, planning, implementation, and… more
- AristaCare (Plainfield, NJ)
- …communication to enhance patient and family satisfaction, adherence to center's clinical systems and regulatory compliance. Requirements + Must possess, ... of a population of patients within an assigned area, unit or clinical function. The position conducts the nursing process, assessment, planning, implementation, and… more
- Sanofi Group (Morristown, NJ)
- …data sources, and applications in US healthcare + Understanding of clinical development and regulatory requirements + Experience leveraging innovative ... Real-World Evidence (RWE) that address critical evidence gaps and support clinical decision-making using existing platforms and through novel studies + **Translate… more
- AristaCare (Edison, NJ)
- …communication to enhance patient and family satisfaction, adherence to center's clinical systems and regulatory compliance. Requirements + Must possess, ... of a population of patients within an assigned area, unit or clinical function. The position conducts the nursing process, assessment, planning, implementation, and… more