Associate Director, Medical Compliance Operations - Material Review

Role Summary

Associate Director of Global Material Review Compliance is accountable for the implementation of processes, standards and compliance monitoring and supplemental medical compliance training supporting the scientific development and review of medical content of pharmaceutical promotional and non-promotional materials for marketed and investigational products/devices. This role ensures presentations of medical, scientific information, and documentation meet standards for pharmaceutical promotion and scientific exchange. It fosters positive, collaborative relationships across matrixed and cross-functional teams including Global Headquarters, Affiliates, US commercial organizations, HEOR, regulatory affairs, legal, public affairs, and OEC.

Responsibilities

• Implement processes and tools to support material development and review compliance to execute strategic plans; establish clear processes, policies and procedures for delivering accurate, high quality and compliant medical and commercial communications globally and in the US.
• Maintain processes and standards outlining requirements for development, review and approval of scientific materials and compliant data source requirements for non-promotional materials for use with externally facing customers.
• Participate in compliance risk assessments, trend analysis and recommendations for compliance business activities.
• Provide expert guidance on regulations and internal policies and their impact on promotional and non-promotional material review processes; apply knowledge of regulatory impact, global business requirements, enforcements, industry trends for global and US audiences.
• Be responsible for reporting metrics and related compliance monitoring for data sources.
• Monitor, report, and remediate related to data sources for materials to determine compliance performance KPIs to mitigate business risks.
• Develop, maintain, and deliver proactive supplemental training materials and communications to Medical Affairs and Health Impact teams to enhance understanding of promotional and non-promotional requirements for approved data sources; assess Global TA team needs related to compliant scientific materials.
• Stay current in AbbVie policies and related regulations affecting Medical Affairs to reflect current Global standards.

Qualifications

• Bachelor’s degree (or ex-US equivalent) with related health science background (BSN, BS, PharmD); advanced degree or extensive experience in operations/excellence preferred (PhD, RN, PharmD).
• 5–10 years of experience in medical review.
• Ability to influence others without direct authority.
• Excellent verbal and written communication skills.
• Strong leadership, analytical, project management, self-management, and organizational skills; able to manage workload and priorities.
• Experience in conflict resolution, problem solving, or crisis management; strong interpersonal and relationship-building skills.
• Ability to operate effectively within a matrixed environment and lead implementation of new initiatives; comfortable with risk and uncertainty.