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

• 5–8 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)