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Content Manager

4 months ago

California, United States ARCH SOLAR C&I INC Full time

Job Description for Promotional Review Editor (PRE)

100% 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 #J-18808-Ljbffr