The candidate must drive the practice to maintain Pharmaceutical company compliance standards. The position's primary responsibility is compliance review of all promotional and non-promotional materials for prescription drugs. The candidate will Independently review, revise and approve content and context required for all promotional and non-promotional materials Effectively understanding healthcare regulations and maintain compliance is critical to ensure that promotional and non-promotional materials created by the agency are quickly approved.
- Ensures that promotional and non-promotional materials meet regulatory and client requirements.
- Ensures that promotional and non-promotional materials meet relevant laws and regulations.
- Provides independent review of promotional and non-promotional materials to ensure that the information conveyed is consistent with the client's product labeling and is suitable for their intended audience.
- Manages and leads medical reviews providing guidance on internal planned HCC documentation preparation process and revision.
- Provides alternative suggestions to internal and client teams to allow for consistent marketing messaging.
- Understands client HCC promotional material process and adheres to submission deadlines.
- Monitors changes in FDA promotional material regulations and informs and updates internal team members, as appropriate.
- Provide guidance to clients on FDA promotional material regulation updates.
- Deep understanding of medical and promotion compliance.
- combined experience in pharmaceutical compliance or legal counsel at Pharmaceutical company. preferably working in a leading pharmaceutical company or marketing agency,
- Effective in managing work and conflict resolution.
- Experience in managing compliance reviews for prescription drugs is required.
- Understanding of client decision making criteria as it pertains to HCC reviews.
- Capable of dealing with ambiguity, and be creative and comfortable working across multifunctional teams.