- Merck & Co. (Rahway, NJ)
- …Global Human Health (GHH) brand/ franchise commercial goals.The Biologics VCM Product Manager (PM) works under direction of the VCM Product Leader supporting the ... product supply strategies for one or more Biologics products. The VCM Product Manager will be responsible for supporting supply chain design, global filing and… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and accountable… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies and… more
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... supplies.-Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related… more
- Merck & Co. (Rahway, NJ)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... and inspections in close collaboration with business stakeholders and the Quality unit, providing necessary documentation and addressing any regulatory inquiries.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated ... CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical programming vendor on project planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution.Leads all aspects of strategic sourcing to ensure best value (cost, quality , Account Mgmt, timelines) for the businesses. Performs in-depth bid analysis ... methodologies are understood and utilized. Serve as the lead "relationship manager " to deliver best practices to the business partners.Leads supplier relationship… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... implement process improvements related to investigations cycle time, closures, quality , and compliance.Develop strategies to increase investigations output while… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. ... and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Merck & Co. (Rahway, NJ)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...Consistently deliver On-Time and In-Full - with First Pass Quality . Oversight and presence on the production floor at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input ... to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes and global ... optimize laboratory data processes, technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development,… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Merck & Co. (Rahway, NJ)
- …in all therapeutic areas to effectively drive their team's strategy.- The staff manager will be expected to monitor quality of project management deliverables ... Director, GPAM, the core responsibility of this Value and Implementation Project Manager role will be direct management of Project Managers, including understanding… more
- Merck & Co. (Rahway, NJ)
- …and analyzing system and passive data governance reports to ensure high quality data and timely and complete synchronization between systems. Acts to resolve ... preparation and overall accounting knowledge. Thorough understanding of data manager packages. Strong understanding of Enterprise Process Management to troubleshoot… more
- Eisai, Inc (Nutley, NJ)
- …the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; develops, reviews and/or approves ... guidelines. 10%4. Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs. 10%5. Functions as… more
- Aldevron (New York, NY)
- …Operational Quality Assurance team and report to the Sr. Manager , Operational QA, responsible for Developing and implementing labeling processes and procedures ... of solutions that safeguard and improve human health.This position is part of Quality Assurance and will be remote with frequent travel to Fargo. At Aldevron,… more
- AECOM (New York, NY)
- …to deliver a better world. Join us. **Job Description** AECOM is seeking a Project Quality Manager to work within AECOM's Transportation Group based in the New ... and support the region's various major Transportation projects and programs. The Project Quality Manager will work as part of a Quality Management Team that… more
