- Sanofi Group (Morristown, NJ)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing. + ... **Job Title:** Clinical Research Director **Location** : Morristown, NJ Cambridge, MA **About...and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director … more
- Bristol Myers Squibb (Princeton, NJ)
- …Collaboration : Serve as the primary point of contact for internal (Medical Affairs , Development, Commercial, Regulatory Affairs , Legal, and Compliance) and ... Proven track record of successfully managing MAPs across a disease area. + Regulatory / Compliance Knowledge: In-depth knowledge of global and local regulations… more
- J&J Family of Companies (Raritan, NJ)
- …close partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs , clinical pharmacology, health economics, and ... & Johnson Innovative Medicine is recruiting for a Medical Director /Senior Medical Director -Clinical Research. They will be...for assigned compound through close partnership with the compound global medical affairs leader. + Serves as… more
- Bayer (NJ)
- …and supplements and manages the US implementation process, acting in close collaboration with global and local RA staff. The position also contributes to the ... ** Director US Labeling & Registration** The Director...revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling operations and strategy… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process ... **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership...+ Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …100+ quality professionals. You will report directly to the Vice President, Quality and Regulatory Affairs for the Laboratory Products Group. **How will you make ... quality products are delivered to customers, maintain a strong state of regulatory compliance and work cross-functionally to improve business outcomes. **What will… more
- Merck (Rahway, NJ)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA ** : Experience supporting/writing ... capabilities, and drive excellence in safety, compliance, supply, and productivity. ** Global Impact:** Collaborate with colleagues across the US and internationally… more
- J&J Family of Companies (Titusville, NJ)
- …monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs ... adverse events (pre and post-marketing) for relationship to treatment** **Assists Regulatory Affairs in determining requirements for any corrective actions… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
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