- Genmab (Plainsboro, NJ)
- …documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics ... authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including experience in regulatory submissions in OncologyManagerial experienceExperience with ex- US regulatory authoritiesTravel - Ability to travel up to ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US ,...groups within the company as needed. In collaboration with Regulatory Intelligence and Policy team members, review… 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 ... Reports to the Market Access and Public Affairs Senior Director , Policy . Other internal relationships include a...from other departments (Corporate Tax, MA, Comm'l BUs, Medical, Regulatory , Legal, etc) Assigned policy areas may… 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 ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… 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 ... Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway,...as GxP Strategic Lead based in Rahway, NJ. Join us and experience our culture firsthand - one of… 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: ... a difference. If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the… 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 ... Job DescriptionThis Procurement Associate Director role will be a member of the...and spoken).Preferred Experience and Skills:MBA or advanced degree.Understanding of regulatory requirements and industry standards related to site services… 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 solid tumor… more
- Eisai, Inc (Jersey City, 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 Associate Director , Medical Writing will be the designated Lead Medical...as the briefing books, Global Investigator Brochures, and annual regulatory reports Leads the medical writing activities for marketing… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… 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
- Eisai, Inc (Raleigh, NC)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... only if they meet all company policies, procedures, and regulatory requirements. This includes reviewing batch documentation and investigating deviations.Process… 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 ... on a variety of Quality or compliance-related issuesInterprets complex regulatory requirements for various audiences, including source area management, and… more
- Merck & Co. (San Diego, CA)
- …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 ... that can be deployed in clinical trials. You will also support preparation of regulatory documents in support of clinical trials.- In addition, you will be the site… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct… more
- Insmed Incorporated (San Diego, CA)
- …and our employees agree. In July 2024, we became Great Place to Work-certified in the US for the fourth year in a row. We are also honored to have been listed ... for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead… more
- Genmab (Plainsboro, NJ)
- …stakeholder network with business and IT&D leaders, with a main focus in the United States .IT&D Partner: Acts as security partner for the IT&D digital leaders ... this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and… 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
- Christus Health (Jasper, TX)
- …translating policy changes into operational programs and services Healthcare Regulatory Environment * Implements programs as needed to comply with diverse ... Develops control and monitoring mechanisms for clinical policies adherence Healthcare Policy and Ethics Compliance * Shares experiences with addressing diverse… more
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