Director, Advertising and Promotion

Otsuka Pharmaceutical Co., Ltd. • Princeton, NJ

2d • $186,489 - $278,875 • Onsite

About The Position

Directs or assists staff member(s) and independently reviews and approves promotional labeling materials and communications for prescription drug and medical device products. Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. May be assigned additional responsibilities as deemed necessary.

Requirements

• 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
• Solid 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
• 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
• Strong judgment, accountability, and the ability to work effectively across multifunctional teams.
• Comfortable operating in a fast-paced environment, managing competing priorities, and providing practical, risk-based regulatory guidance to cross-functional stakeholders.
• Bachelor’s Degree required

Nice To Haves

• 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
• Advanced scientific or clinical degree (e.g., PharmD, PhD, MS) preferred

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 Office of Prescription Drug Promotion (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.
• Monitors 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).
• Participates in 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.

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
• Paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director