- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Legal Director ( FDA promotion /Labeling Drugs & Vaccines) The position provides legal support to the Human Health ... a focus on counseling clients in the areas of FDA promotion and labeling of drugs and...labeling of drugs and vaccines.- The position also provides legal support to the Research Division and Compliance department… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …knowledge and understanding of the Anti-kickback Statute, the False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, government ... the highest ethical & privacy standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** ** Legal Director ( FDA promotion /Labeling Drugs & Vaccines)** The position provides legal support to the ... a focus on counseling clients in the areas of FDA promotion and labeling of drugs and...labeling of drugs and vaccines. The position also provides legal support to the Research Division and Compliance department… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and … more
- Astellas Pharma (Northbrook, IL)
- …and external business partners. + Effectively applies strong working knowledge of FDA guidance and promotion standards to business situations and medical ... the requirements for promotional materials as set forth by FDA . Advises teams on best practices regarding planning and...development. **Organizational Context:** Position will report to a Sr Director or Director of Promotion … more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning ... assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the… more
- Novo Nordisk (Princeton, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion ....concepts that meet business objectives + Provide training in FDA regulations for advertising and promotion to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development and execution ... submissions, regulatory compliance, regulatory advice and counseling, advertising and promotion reviews, and marketing application registration updates in close… more
- Bristol Myers Squibb (Princeton, NJ)
- … FDA regulations and guidelines related to schizophrenia treatment promotion . **Qualifications & Experience** + Bachelor's degree in marketing, Business ... in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Associate Director of Consumer Marketing We are seeking an experienced, passionate… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Review promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with product ... ensure they are free from graphics and text representations that imply product promotion . As an employee of Boehringer Ingelheim, you will actively contribute to the… more
- Lilly (IN)
- …who are determined to make life better for people around the world. As Sr. Director , Counsel for Lilly Value and Access (LVA), you will join the team of attorneys ... in the US This role will work closely with others on the LVA legal team, as well cross-functionally with other attorneys, including those in brand, medical, and… more
- Houston Methodist (Houston, TX)
- …the Houston Methodist Academic Institute and Houston Methodist Department of Legal Services. The Director position responsibilities include overseeing the ... At Houston Methodist, the Director , Research Contracts position is responsible for providing...strategic support for research activities and acts as a legal expert and liaison between all department personnel and… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Associate Director ** **; CMC, Device Development Program Manager** **Functional Area: Technical Operations** ... million people worldwide have disabling hearing loss, and there are no FDA -approved pharmacologic therapies to address its underlying causes. Akouos was founded in… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** As Associate Director , Corporate Counsel or Sr. Associate Director , Senior Counsel, you will play a pivotal role in supporting Boehringer ... Medicine, R&D and selected therapeutic areas. You will provide strategic advice and legal counsel on various regulatory legal issues including marketing and… more
- AdventHealth (Denver, CO)
- …in accordance with trial protocols, Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) ... Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Lead and Director of deviations in conduct, patient status, issues relevant to the… more
- AdventHealth (Orlando, FL)
- …in accordance with trial protocols, Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) ... Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Lead and Director of deviations in conduct, patient status, issues relevant to the… more
- AdventHealth (Orlando, FL)
- …in accordance with trial protocols, Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) ... Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Lead and Director of deviations in conduct, patient status, issues relevant to the… more
- Pfizer (Collegeville, PA)
- **Why Patients Need You** Pfizer and BioNTech's COVID vaccine, COMIRNATY is FDA approved in the US for ages 12+. The US market and the anticipated approval of the ... a threat to public health. Reporting to the Senior Director , HCP Team Lead, the COMIRNATY Sr Manager, HCP...critical role in supporting Field Force Strategy and Non-personal promotion to maximize COMIRNATY share and defend against enhanced… more
- J&J Family of Companies (Horsham, PA)
- …industry standards, and company policies related but not limited to: + Selling, promotion , and marketing of health care products and services + Interactions with ... activities and ensuring involvement of appropriate individuals within HCC, Privacy, and Legal to provide appropriate guidance. In consultation with the Health Care… more
- Pfizer (New York, NY)
- …Pfizer's pediatric pneumococcal next generation vaccine, Prevnar 20 was approved by the FDA in April 2023 and received its ACIP recommendation in June 2023. This ... basis with the Prevnar 20 two Pediatric HCP Directors and the Senior Director , Prevnar 20 Pediatric Lead. This individual will lead the development and execution… more
