- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Training (MCT) team, the manager is responsible for conducting comprehensive medical review and approval of medical content and training ... content and events to optimize training quality and effectiveness.- Conduct comprehensive medical review of materials/programs as member of the MCT team.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access ... preparation, set-up, and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety, CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... diseases and immune disorders. Summary The primary responsibilities of the Manager , Omnichannel Marketing is to support the development, planning and implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and clinical sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... or qualification of global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols (IQ/OQ/PQ), Test… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... RD/PV QA relevant activities including Business Plan, QQR, team building and management review .Involve and attend the Global QA relevant meeting and create the draft… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. They… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... management and to external party for the collaboration program. Participate in the review and analysis of quarterly financial results against plan and monitor key… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... all components are provided and presented in the correct format.Manage document review and approval as needed.Assists with other projects to support the regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …Rewards to manage the US benefit plan administration. The Benefits Manager administers, implements, maintains and develops benefit programs, policies and procedures. ... US benefits plans, including but not limited to group medical , dental, vision, life insurance, short- and long-term disability,...to work at a detailed level to complete or review analysis and develop recommendations, but also look at… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …many stakeholders. Support other quality systems activities, as needed. Support drafting, review and approval of standard operating procedures and any other required ... on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Manager /Sr. Manager , External Manufacture as part of the Technical Development ... the production plan at the CMO's. Leads the management review process with CMO's based on agreed KPI's. Drives...of the projects, risk and mitigation strategy to the manager and cross functional stakeholders. Requirements BS or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating ... such as single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the ... data across programs. Monitor vendor performance by collection and review of metrics and key performance indicators such as...and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as… more
