- 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)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… 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)
- …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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Director , Global Market Access, Cardiovascular;Our company has an exciting and growing CV, Resp, Metabolic and Neuro pipeline, reinforcing our ... access through innovation in patient access models and solutions. T he Director , Global Market Access, Cardiovascular will play a leadership role in developing… 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
- 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)
- …within SM S&T: (1) technical product leadership across the lifecycle of product franchises, (2) project and portfolio management support across pipeline and ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization...at enhancing the skills and competencies of our Technical Product Leaders, Portfolio/ Project Management Organization, and… 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …internal resources and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays a ... key role in talent management of junior engineers while driving departmental initiatives.-A high level of innovation, creativity, and self-initiative along with the… 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
