Remote friendly (Parsippany, NJ)
$90,000 - $95,500 USD yearly
Position: Promotional Review Committee (PRC) / Material Review Committee (MRC) Coordinator
Responsibilities:
- Coordinate end-to-end workflow for promotional and medical communications materials through PRC/MRC review.
- Review submissions for completeness/quality (documentation, references, metadata, supporting materials).
- Verify correct classification, routing, assignment to reviewers/stakeholders.
- Manage review timelines; monitor progress; identify/escalate bottlenecks and workflow risks.
- Coordinate expedited reviews and resolve review issues while maintaining compliance.
- Track approvals, revisions, re-approvals, renewals, expirations, and lifecycle milestones.
- Schedule and facilitate PRC/MRC meetings; prepare agendas/reference packages; capture feedback, decisions, action items, and outcomes; maintain records.
- Administer Veeva Vault PromoMats (workflow management, metadata governance, lifecycle tracking, reporting, user support).
- Perform quality checks aligned to labeling, fair balance, required disclosures, and internal standards; support regulatory submissions as applicable.
- Monitor metrics (cycle times, throughput), analyze trends, improve SOPs/work instructions, and advise stakeholders.
Qualifications/Skills:
- Bachelorβs degree in Life Sciences, Marketing, Communications, Business, or related field.
- 3+ years supporting promotional review/MLR-PRC, regulatory or marketing operations in pharma/biotech/medical device/healthcare.
- Hands-on Veeva Vault PromoMats experience (workflow, routing, metadata governance, lifecycle, annotations, version control, reporting).
- Experience coordinating cross-functional reviews (Commercial, Medical, Regulatory, Legal, Compliance).
- Familiarity with FDA advertising/promotion regulations and OPDP considerations.
- Proficiency with Microsoft Office (Outlook, Teams, Excel, PowerPoint, SharePoint).
- Strong organization, communication, facilitation, stakeholder management, accuracy, and ability to manage multiple priorities in a fast-paced environment.
- Preferred: experience with commercial launches, promotional review metrics/reporting, or global review teams.
Work Location/Travel:
- Parsippany, NJ; regular onsite days. Travel up to 10%.