Manager, Promotional Review Operations

Moderna Services, Inc.

Princeton, NJ

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JOB DETAILS

SKILLS

Acceptance Testing, Corrective Action, Cross-Functional, Decision Support, Document Management, Documentation, Establish Priorities, Forecasting, Identify Issues, Leadership, Legal, Maintain Compliance, Marketing, Material Moving, Materials Management, Metrics, Onboarding, Operational Audit, Operational Improvement, People Management, Problem Solving Skills, Process Improvement, Quality Management, Regulations, Restricted Materials, Source Code/Configuration Management (SCM), Staff Training, Systems Administration/Management, Systems Maintenance, Team Player, Time Management

LOCATION

Princeton, NJ

POSTED

30+ days ago

The Role:This role is responsible for managing day-to-day US MLR (Medical/Legal/Regulatory) promotional review operations for an assigned brand(s). The role ensures US promotional materials move efficiently through submission, review, revision, approval, and publishing in Veeva Vault PromoMats, while maintaining compliance, quality, and predictable timelines.In addition to US MLR operations, this role coordinates the Global review of references and labeling documents, ensuring accuracy, version control, alignment to global standards, and readiness for downstream promotional development and review. The Manager facilitates stakeholder accountability, manages meeting readiness and workflow prioritization, and implements targeted operational improvements within established governance.This role operates within established US and Global promotional review governance and does not have direct people management responsibility.Here's What You'll Do: * Lead US MLR operations across Respiratory: Manage day-to-day US MLR submission and review workflows for assigned brand(s) in accordance with established governance and review standards. * Schedule and facilitate US MLR meetings; own meeting readiness, prioritization, and agenda quality to support predictable execution and on-time delivery. * Support US MLR material submissions to Vault and circulation of materials to appropriate reviewers. * Monitor and manage materials in the approval queue; troubleshoot delays, drive next steps, and proactively resolve operational issues to keep work moving efficiently. * Drive US stakeholder accountability and quality: Provide operational guidance to internal teams and external agencies through the US MLR lifecycle; ensure submission quality via clear requirements, templates, pre-checks, and readiness standards. * Track reviewer comments, decisions, and action items; coordinate timely revisions and resubmissions by coordinating across Marketing, agencies, and review partners. * Coordinate final approvals with US Regulatory partners and support US 2253 submission processes as applicable. * Global references & labeling review: Coordinate the global review and approval workflow for reference documents in partnership with Global Regulatory, Medical, and Labeling stakeholders, ensuring adherence to established global standards. * Partner with Global Regulatory/Medical/Labeling stakeholders to ensure documents are reviewed against established global standards and maintained as approved source-of-truth content. * Maintain approved libraries and/or controlled repositories (as applicable), ensuring stakeholders and agencies have access to current, approved versions. * Identify recurring issues (e.g., outdated references, version misalignment, inconsistencies) and lead corrective actions such as submission quality requirements, documentation updates, and training refreshes. * Own process improvements within established governance: Maintain and improve process documentation (MLR Playbooks, job aids, checklists, training documentation) for US MLR and Global reference/labeling workflows; ensure consistent adoption across teams and vendor partners. * Use reporting metrics and qualitative feedback to identify recurring bottlenecks (rework drivers, late submissions, capacity constraints) and recommend or implement corrective actions within defined processes. * Partner cross-functionally to implement improvements such as submission standards, review meeting structure updates, training enhancements, and queue health improvements. * Vault PromoMats operations and reporting (US scope): Maintain Vault PromoMats content and workflow operations including task reassignments, queue management, running reports, and batch updates to records. * Provide input into Vault workflow/process enhancements; participate in UAT/testing and rollout activities with system owners/admins. * Provide routine operational reporting (cycle time, queue status, adherence to timelines) to stakeholders and leadership to support informed decision-making. * Monitor and report on forecast volume and work with brand teams to prioritize workloads of reviewers. * Enablement and onboarding: Train and onboard new employees and agency/vendor partners on US MLR processes, Global reference/labeling workflows, and Vault usage. * Maintain and update training documentation to reflect process changes and system updates. * Additional support: Provide project support as needed to ensure timely, compliant delivery of promotional materials and controlled documents.Here's What You'll Need (Basic Qualifications) * Bachelor's degree required. * 6+ years relevant experience in markTo view the full job description, click hereApply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjg4NDc4LjEwNDEyQG1vZGVybmF0eGNvbXAuYXBsaXRyYWsuY29t

About the Company

Moderna Services, Inc.

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