- 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. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director , US Oncology - Hematology Scientific Strategy. This talented individual will ... skills.Experienced in bringing promotional materials through legal, regulatory, and medical review .Requires approximately 20% travel, including some weekends.… more
- Merck & Co. (North Wales, PA)
- … monitoring team in review and interpretation of clinical data/ medical protocol-deviations in collaboration with the Clinical Director .Builds talent and ... lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Marketing Digital Engagement will direct the identification, design, execution, oversight, and optimization of ... knowledgeKnowledge of our commercial, regulatory, and legal compliance policiesEnd-to-end medical /legal (PRT) review and delivery processVeeva/PromoMats KnowledgeSAP… more
- Merck & Co. (North Wales, PA)
- …health care providers Experience in a highly regulated environment (with medical /legal review processes) including experience including bringing materials ... that interface with internal and external stakeholders, including US Medical Affairs, Regional Vaccine Medical Directors, Global...through legal, regulatory, and clinical review Strong project management skills as demonstrated by prioritizing… 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
- 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
- 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)
- …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
- 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
