- Legend Biotech USA, Inc. (Piscataway, NJ)
- …Be able to work independently under minimal supervision.Lead, design and optimize research with aims of exploring next generation cell therapies using in-vivo CAR ... virusPerform functional characterization of T cells transduced with in-vivo CAR virus using multiple functional assays but not limited to cytotoxicity assay, serial cytotoxicity assay, and cytokine release assay etc.Help execute the evaluation of in-vivo CAR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support GMA the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan for select indications/projects related to ... evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing budgets and resources for the assigned GMA plan activities, in… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads the development of the US Medical Affairs strategy and execution of the US Medical Affairs plan for select indications/projects related to evidence generation, ... 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)
- …GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development and execution of a unified LinkedIn strategy that spans multiple regions, ensuring it ... 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)
- …Lead/contribute to DS R programming system technology development: Lead/contribute to the R programming system development. Act as R programming SME and functional ... 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)
- …This position oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV and with CROs, vendors, and partners; and ... participates on interdepartmental study teams. This level handles escalated global CSPV case processing issue and handles project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ICSR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, ... both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and… 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)
- …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 a scientific, healthcare or related discipline required Experience QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …below with or without a reasonable accommodation.Education (from an accredited college or university)Bachelor's Degree in Computer Science, Life Science, Engineering, ... 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)
- …CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Group strategy: Sets the vision and strategy for the group including overall vision for a robust risk assessment, mitigation, central (statistical) monitoring 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …positions from Director through Vice President, as needed, and in so doing will provide direct assistance to the project teams, committees and the ... department/function.Attend GPT meetings and assist in creation of drafts of presentations, meeting agendas and action items.Utilizes independent judgment and makes decisions in responding to questions related to assigned matters, processes, and procedures as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts ... with a comprehensive and all-encompassing approach to coordinate activities, under the leadership of the Head of Functional Excellence, across key functions to improve the benefit-risk in patients treated within the oncology compounds throughout the course of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA ... 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)
- …Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; ... Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory procedural documentation, in line with company-wide policy and relevant regulatory requirementsCoordinate with broader DS quality teams to support GRA ... 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
