PRC Submission Specialist

Role Summary
The PRC Submission Specialist is responsible for the end-to-end execution and coordination of pharmaceutical Promotional Review Committee (PRC) / Medical, Legal, and Regulatory (MLR) submissions. This role serves as a key operational partner to Brand, Medical, Legal, Regulatory, Agency, and Operations teams by ensuring materials are submission-ready, accurately routed through Veeva Vault PromoMats, effectively tracked through review cycles, and completed in accordance with established compliance requirements and timelines.
Key Responsibilities
1. Serve as PRC/MLR Point of Contact • Serve as a primary operational point of contact for questions related to the PRC/MLR submission process. • Support stakeholders in understanding requirements, review decisions, process expectations, and submission considerations.
2. PRC Submission Management • Execute assigned PRC/MLR submissions from readiness through review-cycle completion. • Prepare and route materials through Veeva Vault PromoMats. • Monitor status, track comments, manage resubmissions, and document outcomes.
3. Assess Submission Readiness • Verify metadata, references, attachments, supporting documentation, file versions, and required components. • Identify and resolve submission readiness gaps before review.
4. Participate in PRC/MLR Review Meetings • Capture reviewer feedback, decisions, action items, and timelines. • Communicate outcomes and track follow-up actions.
5. Drive Comment Resolution and Rework • Coordinate resolution of reviewer comments across review rounds. • Ensure comments are translated into actionable instructions and resolved before resubmission.
6. Maintain Process Documentation • Support SOPs, checklists, templates, playbooks, and guidance documents. • Document recurring issues and support continuous improvement initiatives.
7. Monitor Workload and Submission Priorities • Maintain visibility of submission volumes, priorities, and timelines. • Escalate capacity constraints and scheduling risks as needed.
8. Quality Checks and Risk Management • Perform quality reviews before submission and resubmission. • Escalate ambiguous requirements, compliance concerns, or process risks.
9. Performance Monitoring and Continuous Improvement • Track submission metrics, turnaround times, review cycles, rework trends, and stakeholder feedback. • Support operational performance reviews and process enhancement activities.
Required Qualifications
• Minimum 5-9 years of experience in pharmaceutical promotional review, PRC/MLR operations, submissions management, regulatory communications, or related functions.
• Demonstrated hands-on responsibility for PRC/MLR submissions.
• Strong Veeva Vault PromoMats expertise.
• Strong understanding of FDA/OPDP expectations, promotional claims, references, and labeling alignment.
• Excellent stakeholder management, communication, prioritization, and quality management skills. • Experience supporting pharmaceutical promotional and marketing materials.
Preferred Qualifications
• Experience serving as an MLR/PRC reviewer or working closely with reviewers.
• Experience reviewing promotional claims, messaging, references, labeling alignment, or creative execution.
• Experience maintaining SOPs, templates, checklists, and operational documentation.
• Experience tracking operational KPIs and identifying process improvements.
Skills & Personal Attributes
• Execution-focused and accountable.
• Highly organized and detail oriented.
• Proactive and anticipatory.
• Strong problem-solving skills.
• Collaborative, diplomatic, and appropriately assertive.
• Adaptable in fast-paced environments.
• Continuous improvement mindset.
• Commitment to ongoing professional learning

Work arrangement
Yes