Healthcare Compliance Director

  •  

Princeton, NJ

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 27 days ago

  by    Sunil Gandhi

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.

Responsibilities:

  • 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.

Qualifications:

  • 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.