- 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 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)
- …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
- Merck & Co. (Rahway, NJ)
- …related experience in pharmaceutical industry or clinical field.Excellent analytical, project management, communication, relationship, team building and ... clinical development pipeline. The role will need to interact effectively with senior leaders within our Company's Global Clinical Development (GCD) division to… more
- 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …needs and/or facilitation. Ownership of National Strategic L&D Initiatives require matrix team leadership to completion of desired project outcome ( project ... development) Effectively establish, deepen, and sustain key relationships with divisional learning team , senior level managers and business SMEs to understand… more
- Merck & Co. (Rahway, NJ)
- …business. Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant ... Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our… 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)
- …adoption of novel process technologies - Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams ... of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design purification processes while develop ing… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is ... cross-functional teams on AI development, consumption, and governance. This leader and their team work closely with...vision Build and evolve the AI Engineering & Automation team to meet internal and market needs Lead… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to take initiative, and ability to think creatively to solve Outstanding team - and client-facing communication skills Project management skills Quantitative ... strategies based on real-world results.We are building an intentional team culture that is made up of diverse skillsets,...you ready to experiment with us? The Position The Senior Manager - Market Access Insights works with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal audits and inspections Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation ... of uniquely complex issues in a simple and understandable manner to ie team members. Relationships Reports to head of NAO Quality PV Oversight. Maintains positive… more
