Full Stack Devops Engineer

Job Description for Promotional Review Editor (PRE)

50% on-site

The PRE has three primary 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 documents 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 the MLR review process.

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.