MLR Submission Specialist

We are seeking a detail-oriented MLR Submission Specialist with 5–8 years of experience in pharmaceutical, medical, or healthcare advertising environments. The role focuses on managing end-to-end MLR submissions, ensuring regulatory compliance, maintaining accurate documentation, and partnering with creative, medical, and account teams to deliver high-quality, compliant marketing materials. Hands-on experience with Veeva Vault PromoMats is mandatory , along with a strong understanding of MLR review processes and submission workflows.

Job Responsibilities: Independently manage end-to-end MLR submission processes, including preparation, annotation, and routing of print and digital marketing assets for review. Own and track submission lifecycles, proactively managing timelines, review stages, and revisions to ensure on-time delivery. Maintain detailed and audit-ready documentation of all submissions, including job codes, references, status, and deadlines.

Interpret and implement client-specific MLR requirements, ensuring strict adherence to regulatory guidelines (including FDA compliance). Perform high-quality QC and proofreading against multiple source documents to ensure accuracy and consistency. Act as a key point of contact for cross-functional teams, including account, creative, and medical teams, ensuring seamless coordination.

Identify process gaps and drive continuous improvements in submission workflows and tracking mechanisms. Proactively flag risks, delays, or compliance concerns, and collaborate with stakeholders to resolve them efficiently. Ensure adherence to established SOPs and regulatory standards, maintaining high-quality delivery across all submissions.

Job Qualifications: 5-8 years of relevant work experience, preferably in science, medicine, or at a pharmaceutical advertising agency. Lead submission activities within Veeva Vault and other platforms (e.g., Fuse), ensuring accuracy, compliance, and adherence to client-specific requirements. Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biochemistry or related disciplines.

Extremely detail-oriented and organized approach. Proficiency in Microsoft Office (Word, Outlook, Excel, PowerPoint) and Adobe Acrobat. Familiarity with PubMed and other databases.