- 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
- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...you ready to make a difference? The Position The Director , Patient Centered Outcomes Research, is responsible for the… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects of ... the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with… more
- Genmab (Plainsboro, NJ)
- …and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional communication, alignment ... pharma consulting, sales, marketing, analytics, or operations.Proven success in product launches and commercial support through various development stages.Strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.Job Description - Director , Digital Assets, Information SecurityPosition Summary: The Director Information ... focus of the role is the active support of product -oriented development (POD) teams in the security of processes...and will be onsite 60% of the timeReporting StructureThe Director Information Security will report directly to the VP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing Real-World Evidence… more
