Director, Advertising and Promotion

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with generous match

Tuition reimbursement

Paid holidays and paid leave programs

Life insurance

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking a regulatory affairs leader to direct and review advertising and promotional materials for prescription drugs and devices in the United States.

The role supports rare disease launches, provides guidance on promotional messaging, and partners with Commercial, Medical, Legal, and Regulatory teams to ensure compliant communications. The candidate will monitor regulatory changes, participate in launch planning, and train staff on promotional compliance.

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance.
• 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.

Responsibilities

• Directs or reviews promotional labeling materials and communications for prescription drugs and medical devices.
• Provide strategic regulatory guidance during pre-launch and launch activities.
• Review materials to ensure consistency with labeling and regulatory requirements.
• Partner cross-functionally with Commercial, Medical, Legal, and Regulatory teams for launch activities.
• Provide training to internal employees and affiliates on promotional compliance regulations.

Skills

Promotion compliance

Cross-functional collaboration

Regulatory strategy

FDA advertising requirements

Launch planning support

Education

Bachelor's Degree

Advanced degree preferred

Tools

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Job description

Job Description

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. 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.

Qualifications Required:

• 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

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

Educational Qualifications

Bachelor’s Degree required; Advanced scientific or clinical degree (e.g., PharmD, PhD, MS) preferred

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.

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 [e-mail].

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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.