- 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
- 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)
- …supply chain design, and continuous improvement of the product's supply chain.-The Director, Operations Research, Strategic Planning will lead a team of analysts ... chain optimization. This role acts as a critical bridge between operations research execution team members, Digital Manufacturing Division, supply chain… 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
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of clinical ... within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers and other clinical operations staff… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for ... at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure successful implementation ... of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally For late-stage programs, executes the Diagnostic development strategy for… more
- Merck & Co. (Rahway, NJ)
- Job Description Lead the Future of Biologics Drug Substance Commercialization! Are you a bold, strategic thinker with a passion for biologics? We're looking for a ... Biologics Science & Technology (S&T) portfolio. In this high-impact role, you'll lead the Drug Substance Working Group (DSWG), mentor scientific talent, and partner… more
- Merck & Co. (Rahway, NJ)
- …of the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead , the Senior Scientist has responsibility for coordinating global Clinical Outcomes ... (PROs) for specific disease areas. The individual will support the PaCES lead on the development, validation, analysis and interpretation of COA endpoints to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respond appropriately to these concerns, barriers, and the evolving marketplace. The role will lead the training efforts and support the needs of a variety of DSI ... Director is also responsible for gaining cross function inputs and lead the projects' execution, tactical implementation, and sustainment leading to improved… 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)
- …a Business Technology Partner (BTP), you will report to the Development IT BTP lead within our company's Research Laboratory IT. You will be part of a team ... business value. This role will initially focus on the Global Clinical Trial Operations (GCTO) functional area, with the growth potential to contribute to other… more
- Merck & Co. (Rahway, NJ)
- …definition and manufacturing process robustness assessment. Primary Responsibilities: Lead development of new, innovative approaches for product development, ... experience. Required Experience and Skills: Prior experience leading formulation development ( Lead Formulator) activities in matrix team environments to define a… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS (RD PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.Design a ... including data management, statistical programming, digital technologies, and clinical operations .Design and implement a fit-for-purpose organization responsible for operational… 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
