- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings ... for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving. Serve as the primary contact with FDA.Lead and prepare FDA submissions, including but not limited to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...resolution meetings, as needed.Partner with CQM to develop a strategy to help address facilitation of risk-based periodic review/update… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director FP&A position is an integral part of the finance ... way to find more optimal and cost-effective approaches that are aligned to our strategy .Financial Plan & Latest Estimates (LEs): Leads the Annual Financial Plan & LE… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Field Medical Training will be responsible for the ... and Contingent Workers requiring therapeutic knowledge of the Daiichi Sankyo portfolio. The Associate Director , Field Medical Training will have a variety of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the ... management processes, tools, methodologies, and scientific know how for overall data collection strategy is a must for the sustainability of the Daiichi Sankyo R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Oncology Medical Affairs, Medical Intelligence is ... analogs and examples from competitors to help design their evidence generation strategy Qualifications: Successful candidates will be able to meet the qualifications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with ... with clinical plans and marketing objectives. Experience with communicating the regulatory strategy , issues, and risks in written and verbal format to regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...Support GMA the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Build and Maintain Metrics Catalog, Dashboards Catalog along with strategy for End User Education and Dashboards adoption.External Benchmarking Competitive ... and RD Line Functions for promotion of Metrics and Dashboards strategy .Team Management Manage the Metrics Business Analyst Team Qualifications: Successful candidates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... clinical trial design. In addition, he/she will develop a QSP strategy to address prioritization across the portfolio of compounds within Oncology/Immuno-Oncology.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Job SummaryThe primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support ... and other health authorities globallyFor late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development, integration, and ... tactics including competitive framework assessment, market research, preliminary brand strategy (buying process, segmentation, brand character/book, positioning, target audience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …subject matter expert for medical coding. Responsibilities Leadership, Direction, and Strategy :Provides medical coding expertise and guidance to the project team ... project/study team expectations regarding quality, time, and cost.Establishes medical coding strategy at the project and/or study level for a larger number… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Associate Director of Digital and Omnichannel Analytics Technology is ... Lead the development and execution of the digital and omnichannel analytics strategy , aligning it with the overall business objectives. Develop and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with PSL/Clinical Safety Physician(s) and cross-functional team to develop safety strategy , key safety messages, and review and author safety sections of ... with PSL/Clinical Safety Physician(s) and cross-functional team to develop safety strategy , key safety messages, and review and author safety sections of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... Publications, Medical Slides, and other related projects). Collaborate with Medical Director responsible for Communication Strategy and Medical Program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of high dollar ... and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and maintains a good vendor base.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development of study protocol (design, sample size, statistical analysis strategy ); Review CRF; Write SAP; Manage statistical analysis outputs with programming ... team; Ensure the interpretation of statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses required, including analyses of patient-reported outcomes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CMC Lead of an early-stage project. He/she has responsibility for the overall strategy and status of the project with respect to budget, timeline, achievement of ... holders, and SMEs to build and execute an effective CMC development strategy .- Leads special project(s)/committee(s) that are critical to Compound development and/or… more
