- 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
- 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)
- …and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....the Oncology drug development preferred.Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Merck & Co. (North Wales, PA)
- …of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices ... Job DescriptionReports to the Director /Senior Director in the Office of...regulatory consultation in the development and implementation of US marketing strategy and promotional programsSupport the US… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist… more
- Eisai, Inc (NJ)
- …a difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... Salary Transparency Language:The base salary range for the Medical Director , US Medical Affairs , Neurology...the employment eligibility of all new hires in the United States . Please click on the following… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... direction and management of digital strategy, effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... for collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. Regulatory PolicyScans the horizon… more
- Merck & Co. (Rahway, NJ)
- …The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... Their role is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial division, ensuring compliance… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… more
- Merck & Co. (Rahway, NJ)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, business development ... Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to join a dynamic area of the business supporting the Disease Area Strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director … more
- Novo Nordisk Inc. (Chicago, IL)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Tris Pharma (Monmouth Junction, NJ)
- …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, etc. to identify, evaluate ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… more
