- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position… more
- Merck & Co. (Rahway, NJ)
- …position will be responsible for providing engineering leadership and cross-functional project support at the Rahway, NJ FLEx (Formulation, Laboratory & ... to meet Clinical Development Program requirements. This will require project /initiative leadership, collaboration and routine interaction with Partner Groups such… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have ... centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior...business acumen who is skilled at both program and project management. This role is responsible for the definition,… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves as ... Associate Director / Director , Analytical Research...in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... externally sponsored research. Provide clear direction and guidance to project teams.Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and ... how the solution will meet the business requirements. Provide project management responsibilities as necessary.- Organize and facilitate problem-solving discussions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation management ... leader, however is also accountable to the VP of quality . The incumbent is expected to understand and apply...that may impact multiple Global organizational units or Global project teams. The incumbent may be tasked under the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based on the ... needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... Services, Project Management and Operational Management. Develop a strong, positive...for Informatics on systems development. Provides technical leadership for project teams Responsibilities Provide the interface between the business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... all Strategic Sourcing efforts through to final contract, including project management, supply analysis, supplier identification, risk mitigation, sourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to ... Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project (s).Strategize and plan for FDA meetings for assigned product.… more
- Merck & Co. (Rahway, NJ)
- … project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF ... compliance representatives, safety partners and other team members to ensure the quality and safe delivery of clinical supplies, and ultimately to enable flexibility… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …responsible therapeutic / franchise area(s). Relationships Reports to Senior Director , Value Communication and Contracting Strategy. Interacts frequently in ... of the payer value story, supported by credible clinical, health economics and quality of life messages in order to justify brand value; interfaces with HEOR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member… more
- Eisai, Inc (Nutley, NJ)
- …service partners are meeting established SLAsApprove and oversee projects and project portfolio.Requirements Minimum of 10 years' related work experienceMinimum of 8 ... root cause of issues creating the best solution for Eisai considering quality , cost, and speed requirements.Strong technical knowledge of systems and applications… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders… more
