- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary:The Associate Director, Oncology Value & Market Dynamics Training Manager is responsible for developing & deploying a strategic ... training plan that equips our teams with advanced skills...To ensure maximum effectiveness of customer facing teams, the manager will work proactively with internal stakeholders to lead… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... and PQCs to Quality leadership and other appropriate company personnelAssists in training , including but not limited to: investigative processes, CAPAs and CPIs,… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT to implement and maintain Eisai's ... with ICH-GCP and regulatory requirements. This role also provides direction, leadership and training on the eTMF to ensure users are effectively utilizing the eTMF… 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) ... within R&D and cross-functionally, to facilitate, roll-out and track just-in-time, role-based training , as processes and ways of working are revised. He/she may also… 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
- 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 ... (SDLC) deliverables (GxP and non-GxP), guidelines, standard operating procedures (SOPs), training materials and user communication notes with the focus on driving… more
- Genmab (NJ)
- …data requirements are aligned with clinical and scientific objectives.Provide SME-level training on lab data management and protocol deviation handling to internal ... teams and vendors.Support cross-study harmonization of data quality practices.Process Excellence and Standards DevelopmentDrive the development and implementation of SOPs, best practices, and standards for external data workflows.Lead or contribute to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standard, develop sample programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials ... analysis- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: create TLFs to support submission QAs in a quick turnaround, support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, ... People Management Leadership: Accountable for the management, development, recruitment and training of employees within the departmental scope to meet current and… more
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