- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... development and execution of an integrated product development plan. This position is accountable for partnering...partnering with the Global Team leader as the Project Management lead on drug development projects. This position can… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry (preferably in a global company).10+ years of expertise in project management , process, product , and/or analytical development activities and oncology ... lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed strategy, as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product , and/or analytical development activities and ... to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible for leading ... and initiatives, such as process automation, to achieve standardized process management Project Management and Strategic Implementation:- Manage global process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering, ... limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will also support more complex projects, including those to acquire new product opportunities or technologies to augment our pipeline. This person is responsible ... in concert with senior GBD Transactions team members; and alliance management participation following successful completion of business arrangements. This role may… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , CMO Operation as part of the Global Manufacturing and Supply team ... position will be part of the integrated CMO virtual management team working with our partner JNJ, to oversee...plan, schedule and track the manufacture of autologous cell product batches at CMOMonitor the progress of product… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Merck & Co. (Rahway, NJ)
- …sales teams to ensure alignment on product vision and execution. Product development process management : Overseeing the development process, including sprint ... Job Description Director of Customer Knowledge Capability & Patient Insights...planning, backlog grooming, and release management . Metrics and analytics: Tracking key product … more
- Merck & Co. (Rahway, NJ)
- …design (Drug Substance, Drug Product , Plant and Clean utilities), product equipment operation, vendor management , process safety and industry guidance ... Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global...the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Director /Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the ... Director of Device Regulatory Affairs for Autoinjector Development Programs....role includes the comprehensive preparation and submission of combination product sections for both commercial and investigational products, such… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, and packaging components… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early...Minimum of five (5) years of experience in project management or a related role required - Product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director Data Science will be responsible for developing and communicating data-driven and actionable insights that drive greater ... minimum of BS (or equivalent) in Data Science, Computer Science, Management Information Systems, IT, or an equivalent scientific/commercial discipline.-MBA or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and execution of ... TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) engages with global… more
