- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in the clinical setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the ... QCP on internal teams including Clinical Development Operations, Global Project Management, Bioanalysis, and Drug Metabolism to design, develop, implement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Efficiency / Continuous Improvement:Provides comprehensive data management expertise to project /study teams to optimize study-specific clinical trial ... high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Safety Scientist Product Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical studies, ... in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation - Project Management:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Tris Pharma (Monmouth Junction, NJ)
- …procure, manage, and control project resources Solid understanding of clinical indications and the drug development process People management experience ... and vendor personnel selection including, but not limited to: Clinical Project Managers, Clinical Trial...Research Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PM or related role in a biotech or pharmaceutical companyDemonstrated success as a project manager /leader in planning and executing strategies for global drug ... rare diseases and immune disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams… more
- Merck & Co. (North Wales, PA)
- …organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late ... simple projects independently or moderate-complexity assignments in conjunction with a partner project manager . Projects could span any therapeutic areas in… more
- Merck & Co. (Rahway, NJ)
- …other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials ... data management strategy for assigned trials within a specific drug /vaccine program.- Develops and manages project plans...clinical data for assigned trials within a specific drug / vaccine program.- Data includes, but is not… more
- Catalent (Harman, WV)
- Job Description: Manager , Supply Chain - WarehouseThe Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a ... significant impact on the way that the Harman's site operates. The Manager , Supply Chain - Warehouse will lead a shift consisting of Warehouse Materials Control… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trials. preferred- Having knowledge of all phases of drug development, including early and late phase clinical development and submission ... and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager /Associate Director, External Manufacture as part of the Global Manufacturing Supply ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewUnder the direction of the Senior Director of Non- Clinical Drug Development and with limited direction, the Business Development Manager will be ... to expand its efforts as a Contract Research Organization.The Business Development Manager will work to uncover and cultivate business opportunities to generate… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... both the commercial and clinical supply chains at Insmed. The primary focus is...to the supply chain processes.DSCSA ComplianceDemonstrate expertise in the Drug Supply Chain Security Act (DSCSA) requirements.Implement and oversee… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the Technical ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within Data… more
