- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development… more
- Merck (Rahway, NJ)
- …in global patient advocacy and engagement activities + US/global experience in regulatory affairs , medical and scientific affairs , and pharmaceutical ... Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research. This position executes the patient… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local labeling… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls (CMC), medical affairs and business development are critical to the success… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the… more
- Sanofi Group (Morristown, NJ)
- …work with medical leads, data managers, statisticians, clinical supplies managers and regulatory affairs specialists, etc.. + ensure compliance with relevant ... regulations, such as Good Clinical Practice (GCP) and internal SOPs + contribute to the development of new drugs and medical devices through clinical trials + May be a core team member of the Global Project Team (GPT), representing and accountable for CSO… more
- J&J Family of Companies (Raritan, NJ)
- …Market Surveillance, Clinical Affairs , Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes. ... reviews across J&J MedTech Surgery in support of Clinical, Medical, and Regulatory needs. These medical writing activities and systematic literature reviews support… more
- Heritage Pharma Labs Inc.d/b/a Avet Pharmaceuticals Inc. (East Brunswick, NJ)
- …and inventory levels. + Collaborate with cross-functional teams, (Production, Quality, Regulatory Affairs , Procurement, Sales & Marketing) to align supply ... and support business continuity planning. + Ensure compliance with regulatory and quality requirements specific to the pharmaceutical industry. Specialized… more
- NRG Energy, Inc. (Princeton, NJ)
- …of ISO settlement statements. + Work closely with the power trading desks, regulatory affairs personnel, and FERC legal counsel in reconciling internal and ... identifying inaccuracies, analysis of energy trading activities, and associated regulatory reports. **Essential Duties/Responsibilities:** + Responsible for all reconciliation,… more
- Abbott (Princeton, NJ)
- …**Familiarity and experience working across functions (eg, Operations/Supply Chain, Quality, Regulatory Affairs , Market Access, Medical Affairs , Finance, ... new media) to deliver our brand experience** **Understand and manage regulatory , compliance and US acute/non-acute care reimbursement** **Set targets, budgets and… more