- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a highly motivated Senior Principal Scientist to join our collaborative Biophysics group within the Mass Spectrometry & Biophysics ... Biophysics group is part of a multi-disciplinary team focused on enabling lead identification to advance our drug discovery pipeline across diverse therapeutic… more
- Merck & Co. (Rahway, NJ)
- …Global Quality Systems role reports to the Clinical Supply Q uality Systems Strategy Lead , within CQMS . This role supports the digital enhancements of quality ... meeting business objectives . - Highly organized with effective project management skills and a track record of successfully...negotiation and problem-solving skills . - Ab ility to lead teams in a matrix organization to achieve objectives… more
- Merck & Co. (Rahway, NJ)
- …adoption of novel process technologies - Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams ... & Manufacturing, in a fast-paced, multidisciplinary environment- - Participate in or lead 1) development of robust and scalable purification processes for biologics… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to support drug substance process development ... for recruiting, appraising, and developing personnel under her/his/their supervision. The leader will maintain a strong network internally and will advance a… more
- Merck & Co. (Rahway, NJ)
- …analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)A project leader ; completes tasks independently at a project ... for the benefit of patients and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM),… more
- Merck & Co. (Rahway, NJ)
- …Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our ... and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable...years in direct management of shop floor production activities. Project Management - Proficient with Project Management… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control ... through launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Design Control will be responsible… more
- Merck & Co. (Rahway, NJ)
- …pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring ... the functions and processes relevant to vaccine development, and project management principles as applicable to the pharmaceutical industry.Primary… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... cluster representative for initiatives at all levels of the organization.Build and lead the team to effectively manage resources ensuring appropriately skilled and… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team; foster a culture of ownership, innovation, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … financial and due diligence efforts and ensure tax collaboration: work directly with the BD project lead as well as legal team to proactively inform them of the ... Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of...Business Strategy and Analytics. Acts as a trusted thought leader for the organization who provides strategic guidance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology, approach, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the designated programs.Ensure proactive representation of Quality professionals at strategic non- project team and at MA strategic discussions. Lead the Quality ... to create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.SummaryThis role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate, and execute ... to optimize and enhance efficiencies and ways of working.Takes ownership and project manages a high volume of high-level projects which involves working with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management function team ... record management principles for Global GxP activitiesResponsibilitiesTraining Function Team Lead development of strategies for the needs assessment, design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as UK and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and ... (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to...(HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ensure robust development… more
- Eisai, Inc (Nutley, NJ)
- …existing products. May serve as the lead regulatory representative on the project team throughout the product lifecycle. Provide senior staff advice and ... dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in order… more
- Eisai, Inc (Nutley, NJ)
- …hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of clinical trial execution ... and successful execution of clinical studies in accordance with the overarching project plans established by the various International Project Team Leaders… more
