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Specialist of Submissions

Bristol Myers Squibb
Full-time
On-site
hybrid
Other
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Specialist of Submissions

Company Name

Bristol Myers Squibb

Job Overview

The Specialist of Submissions supports the Promotional Review Process (PReP) through submission of Promotional Material to the FDA.

Responsibilities:

  • Reviewing and approving submission packages
  • Ensuring data accuracy
  • Maintaining regulatory knowledge
  • Supporting brand matrix teams
  • Managing FDA Form 2253 submissions
  • Reviewing promotional material
  • Working with advertising agencies
  • Supporting the US PReP process
  • Onboarding new users
  • Troubleshooting technical challenges

Requirements:

  • BA/BS degree
  • Minimum of 1 year supporting promotional review processes