- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager , Regulatory Affairs Labeling position will provide Regulatory support for ... global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible for the support ... of the strategic development, oversight, and execution of global monitoring conduct across the DS portfolio. This position will serve to support the project plan of CRA Monitoring Oversight and Excellence and the CSOP as it relates to monitoring and CRO/vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various departments of Daiichi Sankyo. You will join a global team of talented AI engineers collaborating with… 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 ... clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high-quality deliverables, and implements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... adherence to established coding conventions. In collaboration with the Study Data Manager , monitors coding metrics and trends on a scheduled basis and proactively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThe Associate Director, Global Business Process Manager , Global DX is responsible for leading and shaping the company's ... processes, continuous optimization, and digitalization, in collaboration with the Transformation Manager for process automation.- Define and deliver a global BPM… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and ... maintaining the IT Change Management process. You should be familiar with normal, standard, and emergency changes and understand their relationship to other IT service management processes such as Incident Management, Problem Management, and CMDB. Your role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... ownership and management of these processes for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and drive process and policy adaptation within the support teams and across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Sustainability will be a member of the company's Compliance Department and ... will report to the US Sustainability leader and will 1) manage the US Environmental Social Governance (ESG) Sustainability initiatives and partner with colleagues in Japan and at US affiliates to accomplish the company's ESG goals and 2) support various… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... team and performs programming tasks, including SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required for clinical trials. These include developing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategic partnership with business stakeholders: Establish strategic partnership with business stakeholders in Corp. Functions so that they and Global DX develop a ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant Leadership and various Technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role ... OverviewThe Warehouse Operations Manager will work within Technical Operations and be responsible for the ongoing site ramp-up, daily operational management, as well… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.Provide direction to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical Operations. This individual will be responsible for overseeing the… 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)
- …in a biotech or pharmaceutical company.Demonstrated success as a project manager /leader in planning and executing strategies for global drug development, ... commercialization and life cycle management. preferredProven track record as a leader/influencer. preferredDirect people management experience preferredLicenses and CertificationsProject Management Professional (PMP) Certification and/or training in project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 proposal… more
