MLR Submission Specialist

Role: MLR Submission Specialist (Pharma Advertising / Healthcare Communications)

Role Overview

You will own and manage end-to-end MLR (Medical, Legal, Regulatory) submission workflows, ensuring all promotional and educational materials meet compliance, accuracy, and timeline expectations. This role requires strong expertise in Veeva Vault, regulatory standards, and cross-functional coordination.

Key Responsibilities

• Independently manage end-to-end MLR submissions, including preparation, annotation, and routing of print and digital assets
• Lead submission execution in Veeva Vault and other tools (e.g., Fuse), ensuring compliance with client-specific requirements
• Own submission lifecycle tracking—timelines, review stages, revisions, and approvals
• Maintain audit-ready documentation (job codes, references, status, deadlines)
• Interpret and enforce client-specific MLR and regulatory requirements (including FDA guidelines)
• Perform rigorous QC and proofreading across multiple source documents
• Act as a central coordination point across account, creative, and medical teams
• Identify workflow inefficiencies and drive process improvements
• Proactively flag risks, delays, and compliance issues, ensuring timely resolution
• Ensure adherence to SOPs, compliance standards, and quality benchmarks

Stakeholder Collaboration

• Work closely with global creative agency teams
• Partner with design, medical, and account teams to ensure seamless submission execution

Candidate Profile

• 5 plus years of experience in MLR submissions / regulatory operations within pharma or healthcare communications
• Hands-on experience with Veeva Vault (mandatory)
• Educational background in Life Sciences / Pharmacy / Biotechnology / Biochemistry
• Strong understanding of MLR workflows and regulatory compliance (FDA exposure preferred)
• Proficiency in Microsoft Office and Adobe Acrobat
• Familiarity with literature databases (e.g., PubMed)