- 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)
- …meet the needs of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site qualification discussions, kick-off ... centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational...well as programs or franchises.When sitting on a study team , lead the study team … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Head, 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 ... as other research areas centered around rare diseases and immune disorders. SummaryThe Sr . Director, Data Quality and Integrity (Global R&D & PV QA) ensures high… 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
- 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)
- …Proven ability to collaborate with a wide variety of individuals, including senior management, stakeholders, team members, other departments and suppliers Proven ... organization grouped into centralized categories and regional operating teams.The Senior Specialist, NA Transportation Procurement is an integral role that… 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
- 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)
- …Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse ... to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader (TPL) in...Drives Results through Accountability :- Demonstrates effective leadership of team activities to ensure on-time, end-to-end project … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC ... Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters, including performance reviews and departmental talent development.Line management and senior leadership accountabilities in CoELead a team of safety ... project management, writing and analytic skillsMust be organizational leader with ability to influence others and collaborate cross functionally.Must have… more
- Merck & Co. (Rahway, NJ)
- …Team Leadership and Development: Lead , mentor, and develop the leadership team , including Senior Directors, Directors, and Associate Directors, to enhance ... teams.Utilize enterprise leadership principles and ways of working to optimize team performance and enhance project outcomes through effective delegation… 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)
- …in full alignment with global strategy.Regional Supplier Management - Build relationships, lead team to manage supplier performance against business requirements ... the global card program.--The Regional Category Manager (RCM) will work with the global team to lead the development and implementation of a regional procurement… more
