- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... About the Department The Clinical , Medical and Regulatory (CMR) department...positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …devices. The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls ... Their role is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial division, ensuring compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to identify ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director May Be Responsible For:Evaluating pre- clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has...cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical … more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive ... provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. External ... About the Department The Clinical , Medical and Regulatory (CMR) department...the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date of new ... About the Department The Clinical Development, Medical and Regulatory (CMR)...processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management.… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's...scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy… more
- Tris Pharma (Monmouth Junction, NJ)
- …risk management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. ... data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
