- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in ... project management office to enable robust production, testing and release of product to patients.Key Responsibilities Helps to develop and support implementation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... Global Team leader as the Project Management lead on drug development projects. This position can be...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk management activities for his/her portfolio. Serves as the company's senior representative with key high-level internal and external stakeholders on important ... drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk management activities. Providing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and summarize conclusions and recommendations for discussion with and presentation to senior management. Schedule and lead diligence meetings with potential ... disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the...support more complex projects, including those to acquire new product opportunities or technologies to augment our pipeline. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting US approved ... Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and...current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for ... to, areas of GPO/PBM and trade/distribution agreements, Medicare, Medicaid, product pricing, and government price reporting. Coordination with, and appropriate… more
- Merck & Co. (Rahway, NJ)
- …scientists with a focus on drug substance (API) analytical deliverables to drive lead -time reduction and efficiency gains in support of our company's World Class ... Supplier and Operationalizing Quality goals.- The Senior Scientist position is a laboratory-based scientific track role in a fast-paced, multidisciplinary team… more
- Merck & Co. (Rahway, NJ)
- …Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This position will be a ... member of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr. OT...within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles… more
- Merck & Co. (Rahway, NJ)
- …Utilities and Validation. We are seeking a Growth and Improvement minded Senior Scientist, Engineering that can help drive our Strategic Operating Priorities.Invent ... responsibility, mentoring, and leadership of internal and external work. This Senior Scientist, Engineering position leverages significant depth and breadth of… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development (SMARD) is seeking a highly motivated Senior Scientist -Microbiologist to join the growing Microbiology Center of Excellence ... all in a GMP environmentKnowledge and experience with manufacturing and product testingExperience in leading and supporting quality investigations and change… more
- Merck & Co. (Rahway, NJ)
- …to save and improve lives. IT Strategy Realization's (ITSR's) purpose is to lead value-driven outcomes and accelerate how we transform IT. Business of IT (BIT) ... and portfolio management, finance, resource planning and IT master data management.The Senior Specialist of Demand and Capacity Management Customer Success plays a… more
- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical ... areas regarding clinical issues related to oncology compounds.-The Executive Director/PDT lead may:-Manage Directors and/or Senior Directors responsible for… 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 ... living. Are you ready to make a difference? The Position Serve as lead for CRM (customer relationship management) system supporting NNI Medical Affairs. Assumes… 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 ... and executing economic modeling projects. Relationships This position reports to the Senior Director, HEOR Modeling. The role works alongside with other colleagues… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production ... respect to device component manufacture and final assembly of biologic/drug product with device constituent part. Lead /support the development, implementation and… 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 ... you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA)...with Employee Experience (EE)/P&O NAO and Global onboarding initiatives Lead a team of Role-Specific Training Support Partners to… 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 ... lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE)… more
