- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ... input on CRO and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO; establishes effective communication with CRO, ARO, and vendors.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provide GMP compliant product release documentation. Participates as a cross-functional team member to provide product quality/GMP support and assures ... the relevant documents within QA Product Release Management Organization.Cross-Functional Team Participation: Participates and supports development of cross-functional teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, ... and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project budget and resource plan in partnership with the Project Sponsors, Finance team member , and functional line representatives on the teamResponsible for ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late ... position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, ... product safety lead or part of a product safety team , and be responsible for overall product safety strategy...safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration and ensure effective PM resourcing to projects within the portfolio. As a member of the GMP&L leadership team this position is also responsible for ... an integrated drug development strategy and tactical plan including options analysis of team 's proposals in partnership with a Global Team leader for high… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This ... work on projects at any stage of development.As a member of the GMP&L function this position is also...phase of development. Develops and maintains a high performing team . Manages the GPT in partnership with the Global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking a QA Batch Disposition Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level position is responsible for performing ... activities executed in accordance with Good Documentation Practices (GDP).Work in a team based, cross-functional environment to complete tasks required to meet all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member of the Biostatistics and Data Management Data Operations team and ... users to roles based on authorized requests from study team members, periodic review of user access and audit...on the requests submitted by DM and authorized study team members. Proactively identify and resolve issues that may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across various departments of Daiichi Sankyo. You will join a global team of talented AI engineers collaborating with cross-functional teams to deliver innovative ... scalability, and reliability.- Drive the organization's GenAI strategy forward as a member of the GenAI Center of Excellence (CoE). This includes establishing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global Oncology I&A Team and partners closely with Market ... Alliance Partner(s). This individual will work closely with Global Market Research team members to integrate insights and key assumptions into forecast models and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a Sr. Specialist, IT Application Support as part of the IT team based in Raritan, NJ. Role OverviewWe are seeking a highly skilled and proactive ... for Enterprise application (S4)-related issues, collaborating with the application Support team to ensure timely resolution.Coordinate with the Application Support … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update ... assessments for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking an Operations Support Specialist as part of the Technical Operations team based in Raritan, NJ.Role OverviewThe Operations Support Specialist will be part ... of the Technical Operations team responsible for the production of a personalized cell...domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The US Marketing, Hematology, Emerging Assets & TGCT Marketing intern is a valuable member of the commercial brand team and will play a critical role ... in assisting with the development of strategy, tactics and other pressing needs of the business. They will be accountable for assisting marketing partners with content creation and PMRT submission. Furthermore, they will assist marketing partners with LCM… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and personal growth. Global collaboration: Work with a diverse international team . Attractive benefits: A permanent contract with an attractive salary package ... or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager role is an ... This role will also be responsible for the management of the QA Lab Oversight team and will oversee the reviewing and approving of site SOPs, method validation /… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking Technical Trainer - 2nd Shift as part of the Technical Operations team based in Raritan, NJ. Role OverviewTechnical Trainer will be responsible for ... performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Operations Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Operations Supervisor is an ... exempt level position working within Technical Operations team , responsible for directing the daily production of a personalized cell therapy to support both… more
