Senior Regulatory Submissions Lead – In-Office NYC

Omnicom Precision Marketing; New York (NY); Sur place; USD 80 000 - 90 000; Plein temps

Résumé du poste

Omnicom Precision Marketing in New York City seeks a Senior Regulatory Operations Specialist to manage regulatory submissions across Client Medical, Legal and Regulatory groups. You will lead day-to-day submissions, build strong client and internal relationships, and ensure on-time, compliant packages across brands.

The role requires 4+ years of relevant experience, familiarity with MLR processes, and strong writing and organizational skills.

Qualifications

• 4+ years of experience in a relatable role preferred.
• Familiarity with agency submission process and MLR preferred.
• Strong writing and verbal skills; highly organized and detail oriented.
• Workload management and people supervisory experience a plus.

Responsabilités

• Serve as day-to-day submissions lead; manage and filter workload to team members
• Demonstrate general knowledge of Regulatory Affairs and guidelines that govern advertising and promotional material according to FDA
• Work cross functionally with Project Management to ensure submission timelines are met and all material is gathered for accurate and timely submissions
• Learn client-based submission systems and be able to navigate for efficient use, including the tagging and linking of references based on annotations provided by Copy team
• Maintain reference library and asset library for internal cross-functional use
• Execute submissions in the following manner: Initiate the submission process; Track the project from kickoff through to final submission Client MLR approval; Organize submission materials in accordance with Client dictated requirements; Ensure integrity of submission materials to ensure adherence with Client MLR requirements; Submit materials via Client MLR submission platform/tool; Provide status updates on submission progresses; Support team with prepping and sending final samples, and 2253 materials when needed; Record keeping and knowledge base: Document and maintain project tracker; Document and maintain current Client requirements for MLR submission; Maintain knowledge of the Client MLR schedule; Utilize and maintain regulatory document control and appropriate distribution of regulatory documents.

Connaissances

Interpersonal skills

Problem-solving

Written & verbal communication

Organizational skills

MS Office proficiency

Multi-tasking

Cross-functional collaboration

Outils

Veeva Vault

Zinc

Web-based applications

Regulatory systems

Description du poste

Omnicom Precision Marketing in New York City seeks a Senior Regulatory Operations Specialist to manage regulatory submissions across Client Medical, Legal and Regulatory groups. You will lead day-to-day submissions, build strong client and internal relationships, and ensure on-time, compliant packages across brands.

The role requires 4+ years of relevant experience, familiarity with MLR processes, and strong writing and organizational skills.