- 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)
- …and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management , co-development and co-promotion discussions. ... Foster bidirectional communication and alignment between US and Global Medical Affairs.- Oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the… 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)
- …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)
- …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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compound(s) and therapeutic areas (TA), under the guidance of the Associate Director , GOMA Scientific Engagement.Contribute to the management and execution of ... management skills preferredProvide medical expertise to ensure successful product launches across functions preferredBuild strong internal and external… 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)
- …Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled ... descriptionThis position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device… 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)
- …Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for ... Sciences & Clinical Supply. The ideal candidate should have strong project management skills and a demonstrated commitment to operational excellence, with an… 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
- 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
