- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well ... and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Responsibilities- GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development and execution of a unified LinkedIn ... engagement.- Oversee social media agency supporting LinkedIn globalization efforts- Lead internal review process/submission for establishing global channel and… more
- Merck & Co. (Upper Gwynedd, PA)
- …development including assessment of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function ... other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, performance, and… more
- Formation Bio (New York, NY)
- …PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug development programs at Formation Bio. This role requires ... program, managing multiple workstreams while ensuring seamless cross-functional coordination and execution .As a key member of the Program Management team, you will… more
- Merck & Co. (San Francisco, CA)
- …and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline the execution of our Company's DSCS Digital Strategy to enable a seamless data ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and...with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on… more
- Merck & Co. (Rahway, NJ)
- …Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise preparation of multiple product launches in Immunology. You will ... leadership capabilities. Key Responsibilities include: Strategic LeadershipLaunch Strategy Development: Lead the creation of holistic, integrated launch plans that… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... environmentWill be responsible for sub-functional strategic planning, coordinating, and execution of initiatives for the Company's portfolio from discovery to… more
- Novo Nordisk Inc. (Durham, NC)
- … and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and… more
- Merck & Co. (Rahway, NJ)
- …ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of ... and apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for program… more
- Novo Nordisk Inc. (Denver, CO)
- …the communities we serve, and setting the industry standard for extraordinary execution . The team members collaborate and partner cross functionally with multiple ... Rare Bleeding Community Liaison Leader reports to the Strategic Partnership and Engagement Lead and manages a team of Rare Bleeding Community Liaisons. They will… more
- Merck & Co. (North Wales, PA)
- … lead team in key study planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, ... Job DescriptionThis position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material ... sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment… more
- Merck & Co. (Durham, NC)
- …and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding qualification support ... and business processes related to any new project implementations.Site supply chain lead and coordinator for the successful implementation of SAP S4/HANA targeted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of ... during clinical trials and beyond in post approval setting.Responsible for the execution of key safety initiatives aimed at preventing, mitigating, and addressing… more
- Aequor (Thousand Oaks, CA)
- …This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and ... Digital team at ATO B20. The NPI Lead is expected to have ownership over the Technology...NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …MES Engineer will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... in the evaluation of potential process changes for effectiveness, value, risk , and priority.Drive the implementation of MES enhancements that would provide… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... to establish overall project strategy and guide teams in its execution .Conceptualize, plan, and execute projects using effective organizational, prioritization, and… more
