- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and clinical sections of submission documents under guidance of CSL and/or Medical Monitor . Represents Clinical Development on Study Team and collaborates ... functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities Study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...Summary / Objective Serves as a primary source of medical accountability and oversight for one or more clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of the quality strategy in close alignment with the CSPV and Medical Affairs business strategy. Monitor and track implementation and break-down of ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and ...and tools to achieve excellence in trial operations and management. Monitor and ensure compliance and highest quality standards in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... amendmentsLead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... help support the partnership with Clinical Trial Business Operations (CTBO)to:- monitor GCO processes and workstream implementations for effectiveness.- monitor … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Corporate Business Management)Partner and collaborate with global marketing, global medical affairs, global payers and access and commercial business units ... achieving resultsLead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in department specific knowledge,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Functional Units based on moving targets of business needs, keep track of monitor progress of the key deliverables and milestones, evaluating risks to delivery and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... service-level agreements (SLAs), ensuring compliance and high-quality service delivery- Monitor vendor performance, conduct regular evaluations, and address any… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan… more
- Tris Pharma (Monmouth Junction, NJ)
- …to formulate medical understanding of safety and efficacy resultsActs as Medical Monitor for one or more studies, as neededCollaborates with assigned ... applicable statutes and guidances in the pharmaceutical industryExperience functioning as a Medical Monitor Ability to understand patients and health care… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... / lead multiple cross-functional working groups to develop, improve, and monitor global development processes.Process Development: Supports creation of new processes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... global functions including but not limited to Commercial, Marketing, Medical , & Clinical Development,ResponsibilitiesGlobal Market Access Strategy- Lead the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety, CROs ... Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Monitor vendor metrics and provide feedback on performance to Joint… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... patent term extensions, and SPCs.- Works closely with development teams to monitor results, new uses, etc. arising during research and development of products… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... states and DC, with a focus on key states and priority issues. Monitor and analyze state legislative and regulatory developments with potential impact Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... field.- Oversee on-going support for GenAI and other AI solution environments. Monitor and evaluate the performance of generative AI models and algorithms,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... to prescribe data handling, protection, and user provisioning controls- Identify, assess, monitor , document, and communicate potential quality issues in the way data… more
