- 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 ... representing the GCS Planning organization to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic and operational plans… 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 ... associated with clinical supplies for their assigned stud ies , which could vary in complexity . This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serve s as the GCS spokesperson at clinical… more
- 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
- Formation Bio (New York, NY)
- …to patients faster and more efficiently. About the PositionAs a Lead Product Manager , you will help execute on our tech strategy through 0-to-1 product ... conceptualization, rigorous research and experimentation, and iterative development of new products. You will interview, shadow, and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Manager of External Brand & Content Strategy will be instrumental in shaping ... Formation Bio's reputation among key external stakeholders, including investors, industry leaders, and potential partners. Reporting to the Sr. Director of Brand Strategy & Communications, this role is at the forefront of elevating Formation Bio's external… 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
- 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
