- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- Provide CMC regulatory strategy input and expertise...and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance ... technology, drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development… more
- Cardinal Health (Trenton, NJ)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... hands-on guidance of experienced Scientists, learns variety of internal, client, and regulatory systems and develop authoring and project management skills… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of ... budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC...to regulatory agencies and compliance with electronic regulatory standards + Oversees project team members… more
- Merck (Rahway, NJ)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Project Manager **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on ... Project & Planning Management as a Global Project Manager and you'll act as a...a deep knowledge of the contributions across all functions ( CMC , clinical, regulatory , medical affairs, market access,… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Senior Project Manager ** is a key member of the value stream leadership team ... for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value...Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is responsible for leading cross-functional teams… more
- Bausch Health (Bridgewater, NJ)
- …aspects of product development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is ... and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more