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., Pub Med)