- 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
- 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.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)
- …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)
- …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)
- …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)
- …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 ... labeling for drug and diagnostic products. Provides guidance on planning, writing, review of key dossier documents for submissions globally. Ensure high quality… 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)
- …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 ... 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)
- …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)
- …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
- 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you.The Associate Director , Cloud Infrastructure Architect is responsible for the design solutions ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...management design and next generation DC services strategy . Review s and provides recommendations for (current) Data replication… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... Summary This role will lead Contract Operation activities such as membership review , chargebacks, and rebate processing. This position will analyze and interpret… 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
