- Daiichi Sankyo, Inc. (Bernards, NJ)
- … 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality ... disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key ... the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology...For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other functional groups to ensure budgets are always maintained and accurate.Accountable to the Global Team Lead (GTL) and GPT (Global Project Team ) for the ... and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ...with organizational strategies and objectives.- People Leadership - May lead small team ; Coach, motivate and develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical ... This position is accountable for partnering with the Global Team leader as the Project Management lead ...and to drive the development and delivery of the clinical development plan in alignment with the product development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and ... a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... Manager, Data Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating with CROs and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Metrology Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will...policies and regulatory guidelinesHelp improve metrics performance to drive team results in areas of EHS, quality, compliance, cost,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a requirement.Experience directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop ... Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA...the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …depth medical knowledge to provide insights and support to the cross-functional GOMA team including TA lead , medical information & education, patient advocacy, ... medical activities for assigned TA in coordination with GOMA SE lead and other relevant cross-functional stakeholders, and collate for reporting to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input ... Responsible for representing GRA in the GPT (Global Project Team ) as well representing the project team ...governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and coordination of technical training related programs for Raritan CAR-T Manufacturing team members who support cGMP Clinical and Commercial Cell Therapy ... Biotech is seeking Training Coordinator as part of the Technical Operations team based in Raritan, New Jersey. Role OverviewThe Training Coordinator will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …product to patients. This individual will be an integral part of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as ... Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Asset /...following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades… more
