- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes and identifying the latest digital tools and technologies to support MCT activities . The Director serves as primary functional partner and MCT subject ... other research areas centered around rare diseases and immune disorders.SummaryThe Director , Medical Content & Training (MCT) Excellence and Innovation is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oversight of shared e-workspace. (eg, Teams sites, SharePoint).Additional non-Project related activities : The Associate Director , GOCD ensures positive / ... around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence supports process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Responsible for managing budgets and resources for the assigned GMA plan activities , in collaboration with Sr Director .Support medical readiness activities ... IIS Review Committee meetings.Leads selecting medical education and other scientific exchange activities in alignment with the Senior Director , such as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …engagement. Responsible for managing budgets and resources for the assigned GMA plan activities , in collaboration with Sr Director .- Leads medical readiness ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's workload, ... tool. Collaborates with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and ... Controls) activities from early development to post-approval phase for biological,...of all types of submissions to Health Authorities. Coordinates activities required for timely and accurate reporting of information… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... for clinical data collection. Support filing and submission readiness activities ensuring alignment with regulatory requirements.Responsible for the creation and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related ... to Medical Review for their assigned Therapeutic Area (TA). The AD is accountable for ensuring that all scientific content (eg, promotional materials, training materials/programs, corporate communications and select medical material) is of the highest… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence supports ... (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal and written… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to relevant cross-functional stakeholders, to help inform future DS regulatory/development strategies, activities and ways of working. This role will also work with ... topics both globally and regionally, to maximize the impact of policy-shaping activities . This includes supporting the regional reps to build and leverage a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Supports Head Global Strategy and Operations for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review.- ... mid-term plan in Global QA to ensure Global QA activities globally.- Support Head, Global Strategy and Operations to...with Head, Global QA function to ensure Global QA activities globally.Support Operational activities :- Manage the QA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... in alignment with the business strategy.Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and guidance to the project team regarding the medical coding activities and deliverables. Ensures deliverables meet/exceed project/study team expectations regarding ... staff. Project Management:Plans and directs the conduct of medical coding activities for assigned projects/studies through outsourcing (eg, study startup, study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Excellence office who will help manage risk management initiatives and activities defined by leadership. Individual will provide strategic advice, teachings, and ... and execution- Lead/Manage RMP initiatives. Lead and/manage RMP initiatives and activities related to risk management planning, risk management sciences, and risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development, integration, and execution of all ... the development and execution of all pre-launch and launch activities , counter-competitive strategic development, budget management, forecasting as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …provide regulatory support and guidance and manage day-to-day regulatory activities . Collaborate with all disciplines within the Daiichi Sankyo organization ... to obtain and/or provide information/data for regulatory filings.May serve as the single regulatory representative on study teams.Review and interpret regulatory guidelines. Continuing Education:Keep current with regulations and guidance documents; attend… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Job Summary:The Associate Director of Digital and Omnichannel Analytics Technology is responsible for leading ... and budgets. Provide mentorship and guidance to individuals in their day-to-day activities on the effective use of technologies, tools, and techniques to drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant drug and diagnostic regulations on the development and registration activities for the respective medical productsContribute to shared learning forums, ... workshops and training on new guidances, regulations to enterpriseSharing case studies with enterprise Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... DSI colleaguesResponsibilitiesMedical Monitoring- For studies in which Medical Monitoring activities are conducted in-house:- Provides medical input regarding country… more
