- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... Supply Operations team.As Senior Clinical Drug Supply Manager you will play a pivotal role in ensuring...pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: 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...with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of ... a single or multiple clinical trials from strategy outline through to CSR by...outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical … 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, ... with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% Occasional… 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 ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time… 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 ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… 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, ... for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… 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...compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… 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...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key… more
- Tris Pharma (Monmouth Junction, NJ)
- …team success.We have a position in Monmouth Junction, NJ for a Contracts Manager /Paralegal to join our small, but experienced, in-house Legal team.The Contracts ... Manager /Paralegal supports the Legal department in the review, drafting...and agreements (ie, NDAs, service agreements, supply, sales and clinical vendor agreements, etc.) Experience handling multiple aspects of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... for the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Are you ready to make a difference? The Position This role sits in the Clinical Data Sciences and Evidence (CDSE) Division. It plays an important role in supporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Are you ready to make a difference? The Position This role sits in the Clinical Data Sciences and Evidence (CDSE) Division. It plays an important role in supporting… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for leading the development and ... and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, preferably in oncologyExperience developing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Medical Affairs, Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …integral part of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key ... maintenance process. The outcome of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can set the right priorities. After… more
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects and ... collaborate with our Research & Development Division colleagues from Global Clinical Development, the Center for Observational and Real-World Evidence, Global… more
