- Merck & Co. (North Wales, PA)
- Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...in certain states and cities within the United States . Final determinations with respect to… 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
- Genmab (Plainsboro, NJ)
- …patient information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , ... documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… 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.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct regulatory affairs experience, including experience in regulatory submissions in OncologyManagerial experienceExperience with ex- US regulatory ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US ,...the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project… 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
- 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
- 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 in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... 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. (WA)
- …your potential? This role can sit in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex issues that will require an ... locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director of Professional Associations Strategy in Medical Affairs will be responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...including but not limited to, aligned therapy areas, public affairs , and legal/compliance. Relationship Reports to Executive Director… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The Role As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , ... USMA Solid Tumor Portfolio. This role will report to the VP/Head of US Medical Affairs and will be responsible for building and leading the USMA team for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… 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 /...in certain states and cities within the United States . Final determinations with respect to… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leading the strategic planning and execution of data analytics initiatives within the US Medical Affairs organization. This individual is responsible for leading ... development, CMR is involved. The one thing that keeps us all marching to the same beat is our...Partner Engagements Team. Key internal NNI relationships include Medical Affairs therapy areas, other Clinical, Medical, Regulatory … more
- Novo Nordisk Inc. (Omaha, NE)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (North Wales, PA)
- …collaborations with stakeholders in Biostatistics, Clinical Research, Data Management, Regulatory Affairs , and IT.Primary Responsibilities : Determines the ... scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and...in certain states and cities within the United States . Final determinations with respect to… 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 ... regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational...in certain states and cities within the United States . Final determinations with respect to… more
