Director, Advertising and Promotion

About the role

The successful candidate will lead or support the review and approval of promotional materials and communications for prescription drug and medical device products. They will ensure compliance with applicable laws, regulations, and company requirements, and provide strategic regulatory guidance during launch activities.

Responsibilities

• Ensures promotional materials and communications are compliant with applicable laws, regulations, and company requirements.
• Analyzes and interprets new regulations and Guidance to Industry documents, and monitors the impact of OPDP correspondence and enforcement actions.
• Reviews and approves promotional materials and provides strategic guidance on promotional messaging.
• Provides strategic regulatory guidance during pre-launch and launch activities, including review of promotional claims, scientific communications, disease state education materials, and disease awareness initiatives.
• Reviews promotional materials and communications to ensure consistency with approved product labeling, regulatory requirements, and appropriateness for the intended audience and use.
• Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy.
• Responsible for final review and approval of promotional materials, sales training materials, and corporate communications.
• Supports review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education.
• Ensures product promotional materials are submitted to OPDP on FDA Form 2253 in a timely manner and archived as per company policy.
• Maintains awareness of changes in U.S. promotional regulations and corporate policies and procedures, and incorporates those changes into departmental processes, as appropriate.
• Participates in cross-functional meetings and teams, including the Global Regulatory Team (GRT) and Global Labeling Team (GLT).
• Supports launch planning and cross-functional discussions for pipeline and commercialization activities.
• Provides training to internal employees and affiliates on promotional compliance regulations, as appropriate.
• Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate.

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry.
• Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities.
• Experience supporting rare disease products.
• Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments.
• Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment.
• Strong understanding of U.S. regulatory requirements.
• Excellent understanding of medical concepts and terminology.
• Strong understanding of FDA advertising and promotion requirements and applicable product labeling.
• Fundamental understanding of the pharmaceutical industry drug development process.
• Preferred: 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities.
• Experience supporting neurology or other specialty therapeutic areas preferred.
• Experience interacting with OPDP in support of launch programs preferred.
• Experience supporting investigational or accelerated approval products preferred.
• Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders.
• Able to work across multifunctional groups.
• Strong written and oral communication skills.
• Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat.

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.
• Inspired 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.