- Daiichi Sankyo, Inc. (Bernards, NJ)
- …high level of supervision. This position prepares content templates and supports the technical team in the preparation of submission documents (eg, IND, IB, NDA, ... Amendments, Supplements, Briefing Books) for review by higher-level manager . This position demonstrates understanding of key regulatory guidances and their… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Supply Chain) to ensure compliant operations.Process Validation and Product Technical Transfer: Responsible for review and approval of documents associated with ... validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may require DS support. Ensure respective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... Functional Expertise: Serve as a subject matter expert and provide oversight and technical support in the planning, setup, and application of security and access… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring ... compliance with technical and regulatory standards. This role involves efficient resource...communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high-quality deliverables, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , Cleaning ... are proper disinfected. This role will require microbial and engineering technical expertise and troubleshooting ability and shall drive effective communication,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager ... resources and information from established internal contacts; consult with manager for decisions outside established processes.Routinely recognize and resolve… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be ... Manufacturing plant. This individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …promotion for the production of digital content in Adobe Experience Manager . Demonstrates foundational solid knowledge of associated technical disciplines ... REQUIRED The Position The purpose of the Content Project Manager role is to oversee and manage the execution...high level of technical understanding to interpret technical issues for the business and sustain credibility with… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Manager of External Brand & Content Strategy will be instrumental in shaping ... leaders etc. Investors: Biotech, AI, and generalists. Top talent: Particularly technical AI talent and BD/drug-picking experts Content Development: Own execution for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …highest standards of scientific rigor and ethics. The Senior Global Medical Manager will drive and collaborate with cross-functional teams to develop, implement, and ... professionals though robust medical education initiatives. The Senior Global Medical Manager will leverage data-driven insights and foster strong relationships with… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently. About the PositionAs a Lead Product Manager , you will help execute on our tech strategy through 0-to-1 product ... by no means a boundary-you should expect to influence process, help develop non- technical solutions, and know when it's appropriate to license 3rd party software to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical ... in all labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.) coordinating technical support needs with internal IT groups Utilizing FDA portals and tools to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …from new technologies High level of initiative to deliver innovative technical solutions to business requirements Identify, recommend and provide solutions to ... issues that are not immediately obvious in current processes Physical Requirements 10% international travel is required. Qualifications Bachelor's degree in eg Computer Science, Data Science, Supply Chain, Economics, Business Administration, Finance or similar… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure cohesive and comprehensive service delivery. The lead will provide technical leadership, guiding the team in the adoption of innovative technologies and ... ensuring alignment with global and regional business objectives. Provide technical leadership across all non-regulated system implementation projects, guiding the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Operations Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Operations Supervisor is an ... exempt level position working within Technical Operations team, responsible for directing the daily production...and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns ... resources and information from established internal contacts; consults with Supervisor/ Manager for decisions outside establishedprocesses.Provide guidance to other employees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... legal advice, preparing legal documents, negotiating contracts, assessing security and technical provisions. Advises on issues related to data privacy, data… more
