- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA and liaise, negotiate and ... Join a Legacy of Innovation 110 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)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical ... Join a Legacy of Innovation 110 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)
- …Serve as the face of Daiichi Sankyo US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical ... 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)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... ResponsibilitiesProject Responsibilities: Independently manage or lead strategy development on Global Project Teams (GPT) for drug development projects in any phase of development. Develops and maintains a high performing team. Manages the GPT in partnership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …External GBD Stakeholder Communication and Strategic Engagement: Develop an external communication strategy in support of GBD priorities. This includes developing key ... messages to the external GBD community in partnership with leadership. In addition, identifying and prioritizing conference and event sponsorship, membership of appropriate trade organizations, prioritizing and hosting external networking and partnering events… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction, planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Serves as a primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and ... external network. Manages Phase 1-3 studies (depending on assignment) with demonstrated decision-making capabilitiesProvides medical and scientific expertise to cross-functional DSI colleagues.Responsibilities: Medical Monitoring:For studies in which Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Agreements and Contracts:Leads PVA/SDEA Management and maintains oversight of PV relevant contracts. Oversee and set standards for PV contract management. Review ... 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)
- …Leadership: Provide leadership/direction, management and guidance for the responsible team of Business Relationship Manager (BRM) for corporate functions to foster ... 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)
- …HR Systems ManagementAct as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system ... (ie, SAP SuccessFactors).Lead respective workstream(s) to gather, document, implement and validate all system requirements for associated module(s).Serve as the Subject Matter Expert (SME) for respective modules to fully demonstrate knowledge and understanding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will include management of all day-to-day payroll operations and activities for all US (multi-state) and Canada regions, ensuring compliance with company policies 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)
- …areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible for leading ... and shaping the company's global process transformation efforts. This role involves aligning process improvement initiatives with strategic business goals, managing the global process landscape, and fostering collaboration across business and IT units. Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(from an accredited college or university)Bachelor's Degree Degree required in chemistry, biochemistry, pharmaceutics or related discipline within the ... Join a Legacy of Innovation 110 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 ... Join a Legacy of Innovation 110 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)
- …below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Master's Degree or equivalent preferred orPharmD ... Join a Legacy of Innovation 110 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)
- …Program and Project Delivery PgM/PM Assignment: Assign Program Managers (PgM) and Project Managers (PM) to global and regional programs and projects. Vendor ... 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)
- …- Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for ... Join a Legacy of Innovation 110 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)
- …directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products.Seeks and incorporate ... 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
