MLR Submission Specialist

Role: MLR Submission Specialist (Pharma Advertising / Healthcare Communications)\nRole Overview\nYou 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.\n\nKey Responsibilities\nIndependently manage end-to-end MLR submissions , including preparation, annotation, and routing of print and digital assets\nLead submission execution in Veeva Vault and other tools (e.g., Fuse), ensuring compliance with client-specific requirements\nOwn submission lifecycle tracking— timelines, review stages, revisions, and approvals\nMaintain audit-ready documentation (job codes, references, status, deadlines)\nInterpret and enforce client-specific MLR and regulatory requirements (including FDA guidelines)\nPerform rigorous QC and proofreading across multiple source documents\nAct as a central coordination point across account, creative, and medical teams\nIdentify workflow inefficiencies and drive process improvements\nProactively flag risks, delays, and compliance issues , ensuring timely resolution\nEnsure adherence to SOPs, compliance standards, and quality benchmarks\n\nStakeholder Collaboration\nWork closely with global creative agency teams\nPartner with design, medical, and account teams to ensure seamless submission execution\n\nCandidate Profile\n5 plus years of experience in MLR submissions / regulatory operations within pharma or healthcare communications\nHands-on experience with Veeva Vault (mandatory)\nEducational background in Life Sciences / Pharmacy / Biotechnology / Biochemistry\nStrong understanding of MLR workflows and regulatory compliance (FDA exposure preferred)\nProficiency in Microsoft Office and Adobe Acrobat\nFamiliarity with literature databases (e.g., PubMed)