Job Description :
Pay Range $22hr - $25hr
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.
- 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.
- 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 the 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.
- Understanding of Microsoft Office, SharePoint, Adobe / PDF software and the ability to learn document management systems.
30+ days ago