- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …(SMAR&D) group has an exciting opportunity for a director role as Strategic Operations Lead based in Rahway, NJ. As the Strategic Operations Lead within the ... SMAR&D GxP Operations group, you will drive the strategy and logistics for the team responsible for analytical release of raw materials, package components, medical device components, clinical drug substance, and clinical drug product for our small molecule… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our tech strategy through 0-to-1 ... product conceptualization, rigorous research and experimentation, and iterative development of new products. You will interview, shadow, and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... Trial Master Files (TMF) with CSO-related documents.Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... services are developed, implemented, tested, and integrated efficiently and effectively. The Lead will define and drive the methodology, approach, and best practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the...Management and Integration Lead and Process Validation lead on the establishment and management of a process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Cleaning Validation Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Cleaning Validation Lead ... following necessary FDA / Annex 1 requirements. This person will be the lead for cleaning validation program, working cross functionally with various departments to… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for the ... group and in the field of Thoracic Oncology .The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy,… more
- Merck & Co. (Rahway, NJ)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...clinical bulk activities in addition to serving in a lead role for clinical supply issue escalation within their… more
- Merck & Co. (Rahway, NJ)
- …Overall, proven ability to build a data asset strategy & innovation agenda and lead its execution.Strong business acumen with a keen ability to understand how data ... can be leveraged to inform critical commercial decisions and actions.Proven ability to lead a team in analyzing and assessing the commercial value of data assets.… more
- Merck & Co. (Rahway, NJ)
- …you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of impactful ... across the HHDDA portfolio. In addition, you will also lead a team of highly talented individuals working on...to drive results and enable their success.Specific responsibilities include: Lead team to manage life cycle of sales and… more
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... of impact to automation systems with IT driven firewall rule changes. Lead /assist project scopes, define IT and infrastructure deliverables, timelines and estimates… more
- Merck & Co. (Rahway, NJ)
- …opportunity for a Director of Nuclear Magnetic Resonance (NMR).- The NMR Lead provides strategic and technical leadership for NMR capabilities across our ... assessment strategies, and budget management as necessary.The Director, Nuclear Magnetic Resonance Lead , is expected to maintain a strong external network across the… more
- Merck & Co. (Rahway, NJ)
- …in highly-cross function, matrixed teams. Demonstrated ability to collaborate and lead with empathy and compassion.Leading diverse groups of work colleagues and ... ambiguity.Self-motivated, proactive, ability to work independently and collaborate seamlessly. Lead without authority.Ability to understand business process and break… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Operational Excellence, the assigned Global Medical Affairs Team (GMAT) or Functional Lead , and the Franchise or Function Head to deliver GOMA projects and ... and projects Responsibilities GMAT/Function SupportIn close collaboration with the Team Lead (GMAT or Function), establish a strategic plan for monitoring the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical Study Oversight Plan… 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 ... QP2Initiate and manage external collaborations to develop new methodologies and lead our external outreach to the scientific pharmacometrics community Required… more
