- 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
- Merck & Co. (Rahway, NJ)
- …their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs ... development activities (eg engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in the ... at major AD congresses and medical advisory boards, and scientific communication.The Associate Director is a key member of the NBG group responsible for… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is a member ... of Insmed's internal enrollment forecasting tool.Coordinates monthly Clinical Project Review meetings including scheduling, facilitation, finalization of materials, and… 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 ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible 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 ... 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 ... 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)
- …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)
- …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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with… 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 ... internal and external stakeholders. Proven experiences in Oncology Therapeutic area with Medical / Scientific acumen in Solid and Liquid tumors, understanding of the… 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)
- …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 ... QA relevant activities including QQR, monthly quality report, team building and management review .- Involve and attend the Global QA relevant meeting and create the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... process.Responsible for technical support as Insmed's internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets,… 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 ... guidelines- Engages, under supervision, in vendor selection and contracting, including review and negotiation of baseline budget and timelines- Oversees budget… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating ... minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates will be able to meet… 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
