- Eisai, Inc (Nutley, NJ)
- …close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study timelines. Gathers ... Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good… more
- Eisai, Inc (Nutley, NJ)
- …as well as life cycle management of existing products. May serve as the lead regulatory representative on the project team throughout the product lifecycle. ... 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)
- …and successful execution of clinical studies in accordance with the overarching project plans established by the various International Project Team Leaders ... quality, and successful execution of clinical studies in alignment with project plans established by IPTLs.Oversee the TMF department, ensuring the management,… more
- Eisai, Inc (Nutley, NJ)
- …drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; ... of CRO deliverables and on QA of data outputs. 10%5. Functions as lead statistician in global registration trials and manages all related statistical activities.… more
- Merck & Co. (Rahway, NJ)
- …expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader , you will lead the Cell Banking working groups and ... Team as a Biologics Drug Substance & Cell Banking Leader !Are you ready to take your career to the...of diversity, inclusion, and equity. Experience and aptitude to lead , work, and collaborate in internal and external cross-functional,… 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 ... dynamic and visionary-Director, Drug Substance Leader -to drive innovation and excellence across our Biologics Science...& Technology (S&T) portfolio. In this high-impact role, you'll lead the Drug Substance Working Group (DSWG), mentor scientific… more
- Merck & Co. (Rahway, NJ)
- …publication, and presentation at national and international meeting.-They will lead cross-functional product development teams that oversee program strategy and ... study reports, or publicationsParticipating in internal and joint internal/external research project teams relevant to the development of new compounds, and the… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC development ... advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… 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 ... scientific engagement capabilities for the V&I organization.-- The US lead will work directly with the Global and US...support of scientific exchange.Partner with the Medical Modernization EMEAC Leader and other future regional MM leaders on TA… more
- Merck & Co. (Rahway, NJ)
- …candidates from development to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader (TPL) in our Manufacturing Division ... Technical Depth and Breadth of Experience :- Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and… more
- Merck & Co. (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.-.... - At least 8 years of experience in project management . - - At least 5 years… more
- Merck & Co. (Rahway, NJ)
- …lives. Within IT, the IT Strategy Realization (ITSR) team's purpose is to lead value-driven outcomes and accelerate how we transform IT.Are you passionate about ... you! Position Summary As the Communications and Change Management Lead for the Business of IT program, you will...the capabilities and tools delivered by the BIT programCoach project team members to enable effective communications and drive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference ... or national origin.We are seeking a dynamic and strategic leader to join our team as a Director of...This role offers the opportunity to influence, mentor, and lead cross-functional teams while managing large-scale projects that span… more
- Merck & Co. (Rahway, NJ)
- …responsibilities including both performance and talent management activitiesProven leadership and project management skills to lead cross functional teams, drive ... Job DescriptionWe are seeking a strategic and technical leader with expertise in cell culture development &...with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who … more
- Formation Bio (New York, NY)
- …efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic ... 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
- Formation Bio (New York, NY)
- …of generative AI tools Creates the timelines, in conjunction with the project team or relevant subteam, for completion of clinical development and pharmacovigilance ... messaging is consistent throughout all technical documentation to reflect the project and regulatory strategies and requirements. Reviews work of other functional… more
- Merck & Co. (Rahway, NJ)
- …reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise, ... medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process… more
- Merck & Co. (Rahway, NJ)
- …reputation through conference participation.Represent BPR&D as a downstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise, ... medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process… 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 ... includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current… more
- Merck & Co. (Rahway, NJ)
- …newly acquired companies into our platforms and processes. Handle small projects as a lead analyst, project manager, or as the subject matter expert. Account and ... our order-to-cash process. This role offers the opportunity to lead and execute key projects and change initiatives within...regards to the Global IT portfolio and objectives, team's project and initiatives list as regards to strategy, solutioning… more
