Regulatory Operations Manager jobs in United States
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Ogilvy Health · 1 day ago

Regulatory Operations Manager

Ogilvy is a leading global agency network known for its creative excellence and effectiveness. The Regulatory Operations Manager will lead the submissions team, ensuring submission excellence and compliance while managing the Medical Legal Review process across multiple clients and brands within Ogilvy Health.

AdvertisingHealth CareMarketingPharmaceutical

Responsibilities

Ensure successful execution of all MLR submissions across assigned brands, from intake to approval
Maintain expert level knowledge of each brand’s submission requirements and ensure documentation is up to date
Collaborate with account, project management and editorial teams to ensure submission materials are complete, accurate, and appropriately annotated
Oversee and participate in tagging and linking of claims and references in Veeva Vault, ensuring accuracy and alignment with regulatory requirements
Facilitate pre-review quality control checks and ensure all feedback from MLR is captured and addressed appropriately
Track and manage submission timelines and deliverables using internal and client systems (e.g. Veeva, Smartsheet)
Maintain detailed records of submission activity and support preparation of metrics, reports, and audits
Support ongoing training and upskilling of internal teams on submission best practices and system navigation

Qualification

MLR submissionsRegulatory complianceProject managementVeeva VaultMicrosoft Office SuiteAdobe AcrobatCommunication skillsInterpersonal skillsAttention to detailProblem-solvingOrganizational skills

Required

4-5 years of advertising agency experience handling MLR submissions
Project and process management skills, with demonstrated ability to meet deadlines and prioritize tasks
Strong communication and interpersonal skills; able to serve as a liaison between internal teams and external client partners
Excellent attention to detail and organizational and problem-solving abilities
Ability to work independently while managing multiple brands or therapeutic areas simultaneously
Proficiency in Microsoft Office Suite, Adobe Acrobat and submission tracking platforms

Benefits

Competitive benefits package

Company

Ogilvy Health

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Ogilvy Health is a marketing and advertising agency that specializes in the health care industry.