- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as 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,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Privacy & Compliance Investigations, is a member of ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...test plans to ensure all requirements have been met. Review integration test plans and perform integration testing as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position The Health Economics and Outcomes Research (HEOR) Strategy & Synthesis Associate Director , Cardiovascular (CV) will be part of the HEOR Evidence ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...by the RWE and modeling teams within CDSE. The Associate Director , HEOR Evidence Strategy & Synthesis… 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 ... Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is responsible ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other 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...and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of external business development opportunities. Relationships Reports to a Director in Strategic Finance. Internal interactions include stakeholders across the ... and consistency with the strategic scenario forecast process where relevant Review forecasting and scenario model outputs and findings for reasonableness and… 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 ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science 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 ... 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,… 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 ... that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for… 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 ... CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by… 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 ... and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee… 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 CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health… 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 ... of vendor workManage Publication tracking and announcement, in coordination with Medical Director and Medical Information /Education functionContribute… 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 ... development of study protocol (design, sample size, statistical analysis strategy); Review CRF; Write SAP; Manage statistical analysis outputs with programming team;… 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 ... the main interface to internal and external manufacturing sites. Review technical documentation (protocols, reports) associated with manufacturing, technology… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
