Director, Medical and Promotional Review

Otsuka Pharmaceutical Co., Ltd.

2d•$186,489 - $278,875

About The Position

The Director, Medical and Promotional Review is a senior leader in Otsuka's Global Medical Affairs (GMA) organization and serves as the Medical Affairs leader for Medical & Promotional Review across the relevant therapeutic portfolio. Reporting to the Senior Director, Medical Communications, the Director provides strategic scientific leadership for reviewing Medical Information documents and promotional and non-promotional materials through Promotional Review Committee (PRC) and Medical Review Committee (MRC) processes. The role is accountable for scientific content governance, promotional review strategy, organizational capability development, operational excellence, and enterprise risk management. The Director ensures materials are scientifically accurate, balanced, compliant, and aligned with approved labeling and current clinical evidence. The Director is both an active reviewer and a people leader, responsible for consistent review practices, reviewer calibration, governance, and process excellence across therapeutic areas. The role partners with GMA functional leaders, Commercial, Regulatory, Legal, Medical Excellence & Operations, and other internal and external stakeholders to support efficient, compliant content development while maintaining scientific integrity. The Director also advances review processes through training, metrics, benchmarking, and digital and AI-enabled solutions.

Requirements

Advanced scientific degree (PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field).
At least 10 years of pharmaceutical, biotechnology, or healthcare industry experience, including significant experience in promotional and medical review and PRC/MRC participation.
Strong knowledge of relevant therapeutic diseases, clinical development, FDA advertising and promotion regulations, OPDP requirements, and applicable guidance.
Ability to critically evaluate clinical trial data, real-world evidence, and promotional claims, with strong knowledge of biostatistics, evidence evaluation, and claim substantiation.
Demonstrated ability to lead teams, influence cross-functional stakeholders, drive organizational change, and communicate complex scientific information effectively.

Nice To Haves

Experience supporting pre-market approval and commercial launch readiness.
Experience leading reviewer teams, reviewer calibration initiatives, and vendor partnerships.
Familiarity with Medical Information platforms such as Veeva Vault or emerging AI-powered Medical Information solutions.

Responsibilities

Serve as the primary GMA leader within PRC and MRC processes across the relevant therapeutic portfolio, providing strategic scientific guidance and promoting consistent risk-based decisions, evidence standards, and content governance.
Establish review standards, drive organizational transformation, and ensure compliant, scientifically rigorous Medical Affairs and promotional communications.
Conduct and oversee medical review of Medical Information documents, promotional materials, and non-promotional materials for scientific accuracy, balance, compliance, and alignment with approved labeling and clinical evidence.
Lead and develop a team of medical reviewers, promoting consistent scientific standards, risk tolerance, company lexicon, and review best practices.
Provide scientific and business-focused recommendations during cross-functional review discussions and help resolve complex review issues.
Drive reviewer calibration and alignment across products and therapeutic areas.
Lead initiatives to improve review 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.
Oversee document lifecycle management and periodic review of approved materials to ensure alignment with current evidence, approved labeling, and company standards.
Establish and monitor metrics to improve review quality, efficiency, and stakeholder experience.
Partner with Medical Excellence & Operations (ME&O) to optimize review processes and support adherence to established procedures.
Partner across GMA and with 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 as a strategic medical partner throughout content review and approval.
Build partnerships with content originators and proactively identify 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 therapeutic portfolio.
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 stakeholders.
Benchmark review processes against industry standards and identify opportunities for innovation and operational excellence.