Omni Inclusive
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 PromoMats, 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 PromoMats 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
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 PromoMats, 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 PromoMats 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