Promotional Review Editor (PRE)

Promotional Review Editor (PRE)The PRE has three primary responsibilities:Complete an editorial review of promotional and internal materials for accuracy, quality, and compliancePerform a comment verification on documents to ensure Medical, Legal and Regulatory (MLR) advice was incorporated correctlyFacilitate live meetings where MLR Advisors review materials and provided risk assessments to commercial and medical colleaguesResponsibilities:Editorial Review: Review both promotional and internal materials for clarity and accuracy using Veeva PromoMats, our document management systemEnsure materials align to style guidelines, company policies and regulatory requirementsEnsure document submitted for MLR Review align with FDA submission standardsAssist Medical, Legal and Regulatory colleagues with reviews when neededAssist with FDA 2253 and accelerated approval submissions when neededComment Verification: Ensure MLR advice is incorporated and agreed upon with marketing colleaguesTriage advisor comments with commercial and medical colleaguesEnsure materials are ready to be approved for distribution (AFD) and submitted to FDA for form 2253 or accelerated approval submissionLive Meeting: Facilitate discussion of promotional and internal materialsCapture live comments from MLR Advisors in Veeva PromoMatsHelp commercial and medical colleagues navigate MLR review processQualifications:Candidates will need good interpersonal skills, be team oriented and work collaboratively across a variety of functionsCan multitask and meet tight deadlinesGood understanding of English writing, preferably a background in AMA or APA stylesUnderstanding of Microsoft Office, SharePoint, Adobe/PDF software and the ability to learn document management systemsApproximately 1 year of professional experience or relevant background in English, writing or communications