Promotional Review Editor (PRE

Job Description for Promotional Review Editor (PRE)

50% on-site

The PRE has three primary responsibilities:

• Complete an editorial review of promotional and internal materials for accuracy, quality, and compliance

• Perform a comment verification on documents to ensure Medical, Legal and Regulatory (MLR) advice was incorporated correctly

• Facilitate live meetings where MLR Advisors review materials and provided risk assessments to commercial and medical colleagues
Responsibilities
Editorial Review:
Review both promotional and internal materials for clarity and accuracy using Veeva Promo Mats, our document management system
Ensure materials align to style guidelines, company policies and regulatory requirements
Ensure document submitted for MLR Review align with FDA submission standards
Assist Medical, Legal and Regulatory colleagues with reviews when needed
Assist with FDA 2253 and accelerated approval submissions when needed
Comment Verification:
Ensure MLR advice is incorporated and agreed upon with marketing colleagues
Triage advisor comments with commercial and medical colleagues
Ensure materials are ready to be approved for distribution (AFD) and submitted to FDA for form 2253 or accelerated approval submission
Live Meeting:
Facilitate discussion of promotional and internal materials
Capture live comments from MLR Advisors in Veeva Promo Mats
Help commercial and medical colleagues navigate MLR review process
Qualifications
Candidates will need good interpersonal skills, be team oriented and work collaboratively across a variety of functions
Can multitask and meet tight deadlines
Good understanding of English writing, preferably a background in AMA or APA styles
Understanding of Microsoft Office, SharePoint, Adobe/PDF software and the ability to learn document management systems
Approximately 1 year of professional experience or relevant background in English, writing or communications