- Eisai, Inc (Nutley, NJ)
- …within ESI. Continuously update plans and inform stakeholders of progress.Phase IV Clinical Studies : Direct and design strategies, planning and implementation of ... Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs , Medical Affairs and Commercial outputs for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …toGMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical … more
- Merck & Co. (North Wales, PA)
- …headquarters-based position in Our Company Research Laboratories Global Medical and Scientific Affairs (Research & Development (R&D) GMSA). Responsibilities and ... & Biomarkers will be responsible for driving execution of scientific & medical affairs plans for their...to medical affairs strategiesExperience in country/region medical affairs or clinical development (in IBD or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position The Therapy Area (TA) head is accountable for setting an integrated medical affairs strategy, scientific engagement plan and execution of that plan for ... customer needs. Relationships The position reports into VP, Medical Affairs and will have all relevant in-house and field...most up-to-date information on the therapeutic area and NNI clinical plans and study results, product support… more
- Merck & Co. (North Wales, PA)
- …Areas of Interest (AOI)Research: Upon request from Global Center for Scientific Affairs (GCSA),Initiates discussions with SLs and/or potential investigators ... diversityConsistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical … more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …Experience:MSL/Sr. MSLExperience Qualifications:1 or More Years' experience including medical & scientific affairs , clinical practice, research, academic or ... Director MSLExperience Qualifications:5 or More Years' experience including medical & scientific affairs , clinical practice, research, academic or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …internal stakeholders using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed ... Country Medical Affairs required- Experience planning and conducting Medical Affairs interventional and non-interventional studies , including Ph 3b/4, EAP,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …internal stakeholders using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed ... Country Medical Affairs required- Experience planning and conducting Medical Affairs interventional and non-interventional studies , including Ph 3b/4, EAP,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …testingAt the time of implementation of a CDx study /IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once ... by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and… more
- Merck & Co. (Rahway, NJ)
- …functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs , Global Medical and Scientific Affairs to align ... supervision of the TA-Head or CRD.Requires understanding of local regulatory environment. Scientific and clinical research knowledge is required.Understanding of … more
- Merck & Co. (North Wales, PA)
- …support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of ... study results in US promotion.Maintain current awareness of evolving...or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years of… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... may:Supervise the activities of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group of experts in… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional...with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical … more
- Eisai, Inc (Nutley, NJ)
- …ESI. Continuously update plans and inform stakeholders of progress. 30%Phase IV clinical studies : Direct and design strategies, planning and implementation of ... Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs , Medical Affairs and Commercial outputs for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials within an indication or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for ... in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including NNI Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical & scientific input on trial ... clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4)...Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indications.Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Novo Nordisk Inc. (Pittsburgh, PA)
- …in all stages of development. Incumbents have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions ... review, initiation, and completion, as well as publication of study results. Provides clinical support in cooperation...team members to ensure integrated comprehensive coverage of regional clinical and scientific needs Coordinates with key… more
- Eisai, Inc (Nutley, NJ)
- …of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes expert medical/ scientific knowledge in assigned therapeutic ... of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory… more
