- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... advance our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs...in certain states and cities within the United States . Final determinations with respect to… more
- Genmab (Plainsboro, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be ... per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs ,...health authorities as appropriate Monitor and assess global and US regulatory guidelines and regulations and current… more
- Merck & Co. (Rahway, NJ)
- …staff, Pharmaceutical Development colleagues, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, ... Job DescriptionThe Executive Director for Cell Based Sciences within Analytical R&D...in certain states and cities within the United States . Final determinations with respect to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The Role The Associate Director of US Medical Affairs Hematology Strategy will report to ... the Director , US Medical Affairs Hematology Strategy Lead. S/he...through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... the guidance of a senior leader, a Senior Principal Scientist/Senior Director , has primary responsibility for developing value evidence strategies, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Merck & Co. (Rahway, NJ)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications...in certain states and cities within the United States . Final determinations with respect to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical ... development, CMR is involved. The one thing that keeps us all marching to the same beat is our...agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs , Medical Affairs , Convention… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and ... closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage...in certain states and cities within the United States . Final determinations with respect to… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government Affairs & US Corp Giving & Social ... and personal development. Are you ready to maximize your potential with us ? The Position Responsible for developing patient solution strategies that maximize access… more
- Genmab (Plainsboro, NJ)
- …market access and pricing launch strategies.This position is hybrid based in Princeton NJ ( US ) and will report to the Senior Director Global Access and Pricing. ... for value proposition enablement with a focus on clinical, commercial, regulatory , medical affairs , and HEOR stakeholders,Proactively identify and communicate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government Affairs & US Corp Giving & Social ... and personal development. Are you ready to maximize your potential with us ? The Position Execute patient solution strategies that maximize access to therapies.… more
