- 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 ... 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)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics… more
- Merck & Co. (Rahway, NJ)
- …affairs team as necessary. Implement and maintain processes to ensure compliance with electronic submission formats and global regulatory standards, and identifies ... evaluate existing workflows, and implement best practices to improve the quality , accuracy, and speed of regulatory operations activities. Perform regulatory tasks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality ... strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the… 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 role is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product ... quality , integrity and compliance with regulatory guidelines and internal/global standards and procedures. Responsible for managing activities within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations ... (SAP).Study Execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process and technology improvements, defining and implementing the changes for improved quality , integrity, and compliance . Establish metrics to help determine ... areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global markets are also met.Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the ... studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that come out of the Data Governance Program Responsible for definition, control, quality , integrity and policy compliance regarding the Master Data Domain Works ... ready to maximize your potential with us? The PositionThe Manager of Master Data will work within the Master...Team and will have responsibility for Master Data implementation, quality initiatives, and reporting as well as ensuring Master… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensure quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and learn' principles by ... in? Are you ready to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the successful execution of brand/therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensure quality control of marketing content in alignment with compliance Continued Improvement: Ensure pull-through of 'test and learn' principles by consulting ... in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton ... to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical Drug Supply Project/Trial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell ... Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Lab Oversight Specialist role is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.Work closely with operations ... the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.Support manufacturing investigations, create/revise operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... the highest standards of scientific integrity, patient safety, regulatory compliance , and collaboration across therapeutic areas. Ultimately, this position aims… more
