- Merck & Co. (Rahway, NJ)
- …the Sterile Product Development (SPD) leadership team to support the strategy and operations of the organization. This position will have an opportunity to represent ... the SPD function on key strategic initiatives and a variety of opportunities for cross departmental collaboration (eg Finance, Quality, Procurement) across the development areas collaborating with various chiefs of staffs.The incumbent will report to the… 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 ... development, and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities… more
- Merck & Co. (Rahway, NJ)
- …quality measures specified in local SOPs- - Data Centric Business System Owner Operations : Lead the regulatory data governance and standards team, which manages ... are not limited to: - - Data Centric Submissions: Lead the data submissions team that is accountable for...and mediation, ownership, and stewardship roles, including business system operations .- Veeva ARC : Play - - ing a… more
- Merck & Co. (Rahway, NJ)
- …and external stakeholder engagement, working in close partnership with the operations lead .Specific responsibilities include:Oversee the team of Regional Privacy ... and regulators. -The other team drives program governance and privacy operations , supporting privacy compliance through the development and maintenance of program… more
- Merck & Co. (Rahway, NJ)
- …Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with ... is seeking a dynamic and versatile leader for External Manufacturing Operations , Drug Delivery Systems and Devices within our Manufacturing Division (Associate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUS Lead , Medical Modernization - V&IReporting to the Head of Strategy Realization, Medical Modernization, the US Leader for Medical Modernization (MM) ... new content, tools and scientific engagement capabilities for the V&I organization.-- The US lead will work directly with the Global and US TAs to assess and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Facilities Cleaning Program Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Facility ... This person will communicate and provide updates 1st shift facilities and operations teams. The lead will work closely with the cleaning team to ensure all 3rd… more
- Merck & Co. (Rahway, NJ)
- …continuity of supply, and commercial outcomes.The VCM Product Manager will help lead the cross-functional Supply Chain Working Group (SCWG) for pipeline products or ... This is a highly integrative position, and it requires strong large molecule operations and technical knowledge as well as very strong leadership skills to help… more
- Merck & Co. (Rahway, NJ)
- …Scientists and Engineers support internal development and internal/external manufacturing operations to remain operational, continuously improve, and innovate. With ... of process changes for replenishment lots, control strategies, manufacturing operations , investigation evaluations, and regulatory filings.Design, plan, and execute… more
- Merck & Co. (Rahway, NJ)
- …within HR Technology as well as the Global Centers of Excellence (COE's) and Operations Teams. The Senior Specialist will support, assess and manage new demand for ... Privacy and works council approvals are obtained, as requiredWorks with Solutions, Operations and Center of Excellence leads to define the testing strategies while… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality… more
- Merck & Co. (Rahway, NJ)
- …activities to ensure a smooth and clear path to successful GMP operations and BLA filings for the company's pipeline.Leads and/or supports program-specific cell ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be ... to resource allocation internally and through management of business operations and outsourcing budgetsProvide functional representation on committees, task forces… more
- Merck & Co. (Rahway, NJ)
- …a Technical Lead , you will report into Director, Chemical Technical Operations , External Manufacturing API Technology, and play a pivotal role in managing the ... and geographies. Demonstrated capacity to solve complex technical challenges, lead project teams, and influence stakeholders effectively. A solid understanding… more
- Merck & Co. (Rahway, NJ)
- …our Company Manufacturing sites, External Manufacturing, R&D, Quality, Operations , Product Development groups, Regulatory Affairs, Procurement, and suppliers. ... that customer/stakeholder needs are the cornerstone of decisions and expectations- Lead technical investigations of medical device and combination product needs for… more
- Merck & Co. (Rahway, NJ)
- …to provide data-driven insights and solutions. Project Management: Independently lead Real-World Evidence outcome research or advanced AI/machine learning research ... informatics, health informatics, clinical informatics, epidemiology, health economics, biometrics, operations research, engineering, computer science or similar fields. Skills… more
- Eisai, Inc (Nutley, NJ)
- …conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study ... timelines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials. Oversees and resolves operational aspects of clinical trials… more
- Merck & Co. (Rahway, NJ)
- …and/or Continuous Improvement-(40-60%): In addition to Talent Development, may lead various projects within VIPM that would require:Ability to independently ... major corporate change projects can relate to optimizing capabilities, systems and operations , or improving the functioning of teams and / or development processes.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: The TA Oncology Strategy and Execution Lead is a pivotal leadership role responsible for driving the strategic and ... TA Oncology organization The incumbent will be expected to independently lead cross functional initiatives intended to build capabilities, improve processes, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations , Regulatory Affairs CMC, and Clinical Development to collate the ... Initiatives in close collaboration with RD colleagues.Drive discussions with Clinical Operations and the scientific SMEs, prepare and Coordinate responses to queries… more