- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide… 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)
- …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)
- …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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC, with a focus… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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
- Aequor (Newbury Park, CA)
- …Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions. ... Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and...summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance Utilize the… more
- Merck & Co. (Rockville, MD)
- …extramurally to support the company's enterprise policy agenda.Responsibilities of the Director , US Regulatory Policy, will include:Proactively monitoring ... regulatory policy is shaped and developed in the United States .Representing the company in assigned areas...under the supervision of the Executive Director , US Lead, US Regulatory Policy.Participating… 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
- 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and ... categories in the Companion Animal Health market.In this new position, the Director , Parasiticide portfolio Marketing will lead the brand and product portfolio… more
- Merck & Co. (Rahway, NJ)
- …effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Health Economics ... Job DescriptionWe have an exciting Director opportunity to join our global oncology marketing...global brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance forecasting and scenario planning by… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …learning and personal development. Are you ready to maximize your potential with us ? The Position Responsible for the development and execution of data strategies ... focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include… more
