- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical ... Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The 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)
- …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)
- …IB, NDA, Amendments, Supplements, Briefing Books) for review by higher-level manager . This position demonstrates understanding of key regulatory guidances and their ... technical team in preparation of submission documents for review by higher-level manager . FDA Interactions: Leads FDA interactions with high level of supervision.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Manager , US Marketing will be responsible for supporting key work streams in ... sales, to monitor the success of product messaging, programs and promotional effort. The Manager is also responsible for working on a broad array of brand functions… 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 or ... 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)
- …within the commercial drug product and IMP release program to assure all external contractors provide GMP compliant product release documentation. Participates as a ... cross-functional team member to provide product quality/GMP support and assures proper documentation of drug product release programs in accordance with internal procedures. Support proactive planning and forecasting for commercial and IMP relevant activities… 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 ... Data Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the business administration of the CDR/AP system(s) including the areas of study setup, creation and maintenance of standard hierarchy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development ... and management of other ad hoc special projects as they arise. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)-… 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)
- …and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes creation ... 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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , ... Cleaning Validation will be responsible for creating and maintaining the cleaning validation program for the Cell Therapy facility following necessary FDA / Annex 1 requirements. This person will be the lead for cleaning validation program, working cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and have an in depth understanding of project strategies/plans.As a staff manager , responsible for coaching PMs on project-related issues including review of their ... or Pharmaceutical industry10 or More Years Demonstrated success as a project manager /leader in planning and executing strategies for global drug development: early… 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 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 Operation and Quality functions in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.Creates, implements, and presents training programs and materials on ... legal issues for various departments. Monitors current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding same.Leads cross-functional project management teams set up to address mid-sized to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company agreements. As necessary, negotiate with opposing party with support from manager or attorneys to resolve contract language disputes. Communicate daily with ... colleagues within Contract Management to assist with other submissions where necessary.Manage, administer and maintain the Legal Affairs Intranet page. This includes developing new forms, posting procedures, working with IT in posting and linking updated… more
