Director, Medical and Promotional Review

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 identify opportunities for innovation and operational excellence. Qualifications Minimum Requirements Advanced scientific degree (PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field). 10+ years of pharmaceutical, biotechnology, or healthcare industry experience, including significant experience in promotional and medical review and PRC/MRC participation. Strong knowledge of the relevant therapeutic diseases, clinical development, FDA advertising and promotion regulations, OPDP requirements, and applicable guidance. Demonstrated ability to critically evaluate clinical trial data, real-world evidence, and promotional claims, with strong knowledge of biostatistics, evidence evaluation, and claim substantiation. Proven ability to lead teams, influence cross-functional stakeholders, drive organizational change, and communicate complex scientific information effectively. Preferred Knowledge, Skills, and Abilities Knowledge of the relevant therapeutic diseases Experience supporting pre-market approval and commercial launch readiness Experience leading reviewer teams, reviewer calibration initiatives, and vendor partnerships. Familiarity with MI platforms (for example, Veeva Vault) or emerging AI-powered MI solutions Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline: This will be posted for a minimum of 5 business days. Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112. Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591 Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting EEAccommodations@otsuka-us.com. Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. 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Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.