- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs.Ensure proactive representation of Quality professionals at strategic non- project team and at MA strategic discussions. Lead the Quality Reviews of ... strategic direction pertinent to MA activities for internal QA team (global/ local), but also to:Global Project ...and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document and record management principles for Global GxP activitiesResponsibilitiesTraining Function Team Lead development of strategies for the needs ... training across DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 timelines ... of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In addition,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA ... and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory...and risks in written and verbal format to regulatory senior leadership team and other governing bodies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...targeted source document verification and targeted source data review. Lead the team to develop and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of vendors to support training priorities.Will be expected to serve as the lead with the vendor & project management requirements for initiative completion.Will ... to deliver the materials.Will be required to partner with Senior Training Leadership in the identification and selection of...training priorities. Will be expected to serve as the lead with the vendor & project management… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Sr . Specialist position is part of the GRACS US Subsidiary function within our company's Research Division. Our mission is to serve as a trusted ... regulatory center of excellence and lead successful interactions with FDA regarding select US topics,...Director, you will be an integral part of the team , focusing on key activities related to drug shortages,… 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)
- …and reporting deliverables for R&D projects (data,-analyses, tables, graphics, listings)- A project leader ; completes tasks independently at a project ... safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are-executed efficiently with… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development Microbiology group has an opening for a Senior Scientist - Microbiologist. Join us and experience our culture first-hand one ... for improving human health. As part of our global team , you will have the opportunity to collaborate with...and expanding your career.-- - In your role as Senior Scientist, you will be a critical part of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to… more
- Merck & Co. (Rahway, NJ)
- …Molecular Microbiology, Pharmacodynamics, Pharmacokinetics, Pharmacology, Professional Networking, Project Team Development, Protein Purifications, ... Job DescriptionWe are seeking a highly motivated Senior Principal Scientist to join our collaborative Biophysics...Biosciences. The Biophysics group is part of a multi-disciplinary team focused on enabling lead identification to… more
- Eisai, Inc (Nutley, NJ)
- …with the overarching project plans established by the various International Project Team Leaders (IPTLs). This role requires a deep understanding of ... 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… more
- Eisai, Inc (Nutley, NJ)
- …May serve as the lead regulatory representative on the project team throughout the product lifecycle. Provide senior staff advice and guidance on ... dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in order… more
- Merck & Co. (Rahway, NJ)
- …early adoption of novel process technologies.Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams ... reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise,… more
- Merck & Co. (Rahway, NJ)
- …early adoption of novel process technologies.Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams ... reputation through conference participation.Represent BPR&D as a downstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise,… 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 ... biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team… 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 ... candidate will be a member of the BPD Leadership Team and directly responsible for a team ...recruiting, appraising, and developing personnel under her/his/their supervision. The leader will maintain a strong network internally and will… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has ... areas regarding clinical issues related to oncology compounds.-The Executive Director/PDT lead may:-Manage Directors and/or Senior Directors responsible for… more
