- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the ... optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... 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)
- …Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality ... oversight across all Medical Affairs programs. This role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as other BDM functions, sets the vision, direction, ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for implementation of clinical studies ... 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)
- …HCP Engagement folders - Establish and manage the monthly HCP Engagement Folder audit process, to ensure information is documented and reported timely.Folder Audit ... includes:Review HCP Engagements that are considered closed according to the policy ensuring all documents are uploaded into the appropriate section of the folder, audit check list is completed and signed by appropriate parties.Conduct the audit and present any… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan for select indications/projects related to evidence ... 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)
- …The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory activities related to the review, approval, and compliance of advertising ... and promotional materials for the company's pharmaceutical products. This leadership role is critical in ensuring that all promotional strategies align with FDA regulations, industry standards, and corporate objectives while effectively supporting commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support process operations by performing support specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Participate in Vein-to-Vein, S&OP (CRR), Site Supply Chain, and Operations meetings (eg, Production Ramp Up plan) to assess manufacturing constraints and prioritize ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead global sourcing for assigned direct materials category for a fast-growing commercialized CAR-T product.Develop a long-term category strategy aligned with product ... growth and supplier diversification.Support building a high-performing global sourcing organizationAssess and periodically update risk scores for BOM and other high-risk materials.Co-develop sourcing scoreboards, KPIs, and metrics to enhance visibility across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Ensure the timely completion of high-quality robust investigations with appropriate root cause(s).Ensure appropriate Corrective and Preventative Actions (CAPA's) are ... developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection… 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 ... university)Bachelor's Degree in Accounting, Finance, or related field requiredMBA in Finance preferred Experience Qualifications 7 or More Years experience in accounting and/or Financial Planning and Analysis-related work, and/or pharmaceutical/R&D experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi ... Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaborate with alliance partners, Global and Regional Medical Affairs and various cross functional teams to develop and execute publication plans of assigned GMA ... Oncology product- Facilitate Publication discussions- Liaise with internal external authors, academic research organizations, and study investigators- Manage vendor budget and activities- Oversee the quality and timeline of vendor work- Collaborate with study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This individual's primary responsibility will be support of manufacturing process optimization through process modelling, new technology integration, and various site ... expansion initiatives.Establish relationships and work cross functionally with local and global stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality.Work closely with Sr. Manager, Strategic Initiatives to… more
