Job Summary
A global healthcare and pharmaceutical company has an open position for a Remote Regulatory Advertising and Promotion Policy Director.
Core Responsibilities Include:
- Advising on the development of US labeling to ensure support for anticipated promotional messages and claims
- Establishing and nurturing a productive, transparent relationship with OPDP and/or APLB to achieve successful and timely review
- Identifying continuous improvement opportunities
Applicants must meet the following qualifications:
- Experience as a primary reviewer on promotional review teams
- Bachelor's Degree & experience in pharmaceutical/biologics regulatory, or scientific disciplines
- Experience working in cross-functional settings
- Experience managing and executing on projects
- Experience anticipating issues and providing mitigating solutions to help optimize development of quality promotional materials/programs
- Experience in the review of prescription drug advertising and promotion for compliance with applicable US FDA laws, regulations and guidance documents