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The primary responsibility of a Promotional Review Editor (PRE) in Commercial Regulatory Affairs is to proofread and copy edit documents classified as promotional material ensuring that company implements product promotion consistent with company policies, AMA style guidelines, and applicable FDA ...

Job Description

The primary responsibility of a Promotional Review Editor (PRE) in Commercial Regulatory Affairs is to proofread and copy edit documents classified as promotional material ensuring that company implements product promotion consistent with company policies, AMA style guidelines, and applicable FDA regulations and guidance.

Responsibilities:

  • Proofreads promotional material, disease awareness materials, and Important Safety Information associated with assigned brands/therapeutic areas
  • Performs initial review of promotional materials (2253 submission packages) for marketed products
  • Offer educated opinion based on their knowledge of AMA writing style
  • Captures consensus comments during live committee review meetings
  • Ensures requested changes are incorporated appropriately during Approval For Production (AFP) stage
  • Assists with review of draft advertising promotional materials for Advisory Comment submission packages
  • Assists with Form FDA-2253 submissions and OPDP advisory comment submissions
  • Assists with review of promotional layout of USPI materials

Qualifications:

  • BS required
  • Proofreading experience or copy editing preferred
  • Detail & deadline oriented; well organized
  • Excellent verbal and written communication skills
  • Good interpersonal skills; ability to interact with staff across matrix partners