Director, Medical and Promotional Review
Listed on 2026-10-31
-
Management
Regulatory Compliance Specialist
Remote
Full time
R13121
The Director, Medical and Promotional Review is a key leader within Otsuka's Global Medical Affairs (GMA) organization, serving as the Medical Affairs leader for Medical & Promotional Review for the relevant therapeutic portfolio, accountable for scientific content governance, promotional review strategy, organizational capability development, operational excellence, and enterprise risk management. Reporting to the Senior Director, Medical Communications, this role provides strategic scientific leadership for the review of Medical Information documents, and for the review of promotional and non-promotional materials through Promotional Review Committee (PRC) and Medical Review Committee (MRC) processes, respectively.
The Director will ensure that materials are scientifically accurate, balanced, compliant, and aligned with approved labeling and current clinical evidence.
The Director will serve as both an active reviewer and people leader, driving consistent review practices, reviewer calibration, governance, and process excellence across therapeutic areas. The role partners closely with GMA functional leaders, Commercial, Regulatory, Legal, and other internal stakeholders to enable efficient, compliant content development while maintaining the highest standards of scientific integrity.
Key Responsibilities
Medical and Promotional Review Leadership
Serve as the primary GMA leader within PRC and MRC processes across the relevant therapeutic portfolio, providing strategic scientific guidance ensuring consistent application of risk-based decision making, evidence standards, and content governance principles .
Establishes review standards, drives organizational transformation, and ensures compliant, scientifically rigorous communications across all Medical Affairs and promotional content.
Conduct and oversee medical review of Medical Information documents, promotional materials, and non-promotional materials, ensuring scientific accuracy, balance, compliance, and alignment with approved labeling and clinical evidence.
Lead and develop a team of medical reviewers, driving consistent application of scientific standards, risk tolerance, company lexicon, and review best practices.
Provide scientific and business-focused recommendations during cross-functional review discussions and support resolution of complex review issues.
Drive reviewer calibration and alignment across products and therapeutic areas to ensure consistent decision-making and scientific assessment.
Content Governance and Process Excellence
Lead initiatives to optimize review processes, enhancing quality, efficiency, consistency, and scalability.
Apply digital and AI-enabled solutions to streamline review workflows and improve operational effectiveness.
Support content governance, reviewer training, onboarding, and development programs to ensure consistent application of review standards.
Oversee document lifecycle management and periodic review of approved materials to ensure continued alignment with current evidence, approved labeling, and company standards.
Establish and monitor metrics that drive continuous improvement in review quality, efficiency, and stakeholder experience.
Cross-Functional Partnership
Partner closely with Medical Excellence & Operations (ME&O) to optimize review processes and support adherence to established review procedures.
Partner across GMA and key cross-functional stakeholders to provide strategic scientific input and ensure compliant development and review of medical and promotional content.
Represent GMA on core teams and PRC, serving as a strategic medical partner throughout content review and approval processes.
Build strong partnerships with content originators, proactively identifying scientific, clinical, and compliance considerations during content development.
Collaborate with vendors, agencies, and external partners to support review activities and operational excellence.
Facilitate alignment on scientific messaging, claim substantiation, evidence standards, and appropriate use of clinical data across the relevant therapeutic portfolio.
External Insights and Best Practices
Maintain expertise in FDA advertising and promotion regulations, OPDP enforcement trends, FDA guidance on responding to unsolicited requests, and evolving review practices.
Promote best-practice sharing, reviewer development, and continuous learning across review teams and key stakeholders.
Benchmark review processes against industry standards and…
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