- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement clinical ... CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data...collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support DS Program developments. This position provides expertise within the Biostatistics and Data Management teams by having the Medical / Scientific knowledge ... role. In addition, significant experiences in the use of data management systems (EDC, MDR, CDR), knowledge...of data driven methodologies for collection of quality data complying to industry standards CDISC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medical Director responsible for Communication Strategy and Medical Program Management on tracking and management of budget.Support Head of Publications- ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …systems, incorporating relevant advancements to optimize system performance and functionality.- Data Quality , Testing and Release ManagementEstablish and enforce ... principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system...privacy.Implement processes to regularly test, audit and validate HR data to maintain high data quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is responsible for the ... management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to create submission plans that result in high … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned ... well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and outside of ... risks.Manage and oversee the CTOR team who support GCO Quality by Design, risk and issue management ....plans and execute key initiatives and assesses their impact.Understand data /metrics/key performance and quality indicators to support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …portfolio or specific therapeutic areas from Phase 1 through life cycle management . Provides oversight of statistical activities performed by direct reports or staff ... the global function to support drug development and life cycle management . Represents the function in global regulatory/heath authorities' meetings. High-level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensuring accurate and reliable data is captured from various channels. Ensure data quality and accuracy.- Analyze and interpret data to derive ... or more years of IT experience, with a focus on digital analytics, data management , or related roles supporting the pharmaceutical industry.4 or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Infrastructure, 2) Identify innovative approaches, industry best practices, tools, and data strategies to support best in class diversity and patient voice ... to operationalize the feasibility approaches.Partner with internal and external data /systems centers of excellence to identify, monitor, analyze and appropriately… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coding library management .Manages, reviews and approves medical coding of clinical data ensuring high quality ; creates and manages the synonym-lists to ... drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and qualitative means. Candidate will define Key Performance Indicators, Key Quality Indicators, Key Risk Indicators, and other targeted operational metrics in ... Education and Dashboards adoption.External Benchmarking Competitive Intelligence. Leverage public source data (Citeline , CMR , KMR, MCC ) to evaluate competitive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... updated Core Data Sheets, EU and US Documentation: As the project...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical ... corporate communications and select medical material) is of the highest scientific quality and is compliant with all relevant policies, procedures, and regulations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Commercial & Strategy, Global Forecasting & Insights and Global Project Management . Successful execution will involve working cross-functionally to gather relevant ... Valuation NPV Modeling Financial Support: - Provide independent and high- quality financial support to all BDL transactions including In-Licensing, Out-licensing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientists and clinical operations. The candidate must have effective project management skills and communicate progress and risks toward the timely testing ... leads and clinical development staff in the timely deployment of high- quality biomarkers analysis on clinical samples. Responsibilities 1. Independent contributor in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines ... strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc. - Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
