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Job Description for Promotional Review Editor (PRE)

100% on-site

The PRE has three primary responsibilities:

1. Complete an editorial review of promotional and internal materials for accuracy, quality, and compliance
2. Perform a comment verification on documents to ensure Medical, Legal and Regulatory (MLR) advice was incorporated correctly
3. Facilitate live meetings where MLR Advisors review materials and provide risk assessments to commercial and medical colleagues

Responsibilities

Editorial Review:

1. Review both promotional and internal materials for clarity and accuracy using Veeva PromoMats, our document management system
2. Ensure materials align to style guidelines, company policies and regulatory requirements
3. Ensure documents submitted for MLR Review align with FDA submission standards
4. Assist Medical, Legal and Regulatory colleagues with reviews when needed
5. Assist with FDA 2253 and accelerated approval submissions when needed

Comment Verification:

1. Ensure MLR advice is incorporated and agreed upon with marketing colleagues
2. Triage advisor comments with commercial and medical colleagues
3. Ensure materials are ready to be approved for distribution (AFD) and submitted to FDA for form 2253 or accelerated approval submission

Live Meeting:

1. Facilitate discussion of promotional and internal materials
2. Capture live comments from MLR Advisors in Veeva PromoMats
3. 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. They should be able to multitask and meet tight deadlines. A good understanding of English writing is preferred, with a background in AMA or APA styles. Understanding of Microsoft Office, SharePoint, and Adobe/PDF software is necessary, along with the ability to learn document management systems. Approximately 1 year of professional experience or relevant background in English, writing, or communications is required.