Director of Advertising and Promotion Strategy

As the Director of Advertising and Promotion Strategy, you will lead our efforts in reviewing, approving, and strategizing promotional materials and communications for prescription drugs and medical devices. Your expertise in regulatory requirements will be essential in ensuring that our promotional and training materials comply with all applicable laws and company standards. This position serves as a strategic regulatory partner, especially focused on rare disease product launches and commercialization activities.

Key Responsibilities:

Ensure promotional materials and communications adhere to legal, regulatory, and company requirements while analyzing new regulations and Guidance to Industry documents.Review and approve promotional materials and provide strategic advice on effective messaging.Offer regulatory guidance during pre-launch and launch phases, including the evaluation of promotional claims and medical communications.Confirm promotional consistency with approved product labeling and appropriateness for the target audience.Collaborate with Commercial, Medical, Legal, and Regulatory teams to enhance promotional strategies and support launch activities.Conduct final reviews and approvals for promotional materials, sales training content, and corporate communications.Support the review of materials related to specialized disease states and patient education.Ensure all promotional materials are submitted to OPDP timely using FDA Form 2253 and archived according to company policy.Track changes in promotional regulations and corporate policies, integrating updates as necessary.Engage in cross-functional meetings, contributing to Global Regulatory Team (GRT) and Global Labeling Team (GLT) discussions.Participate in the planning and collaborative discussions for pipeline commercialization activities.Provide training to internal staff and affiliates on compliance with promotional regulations.Act as a liaison with OPDP, facilitating discussions on promotional strategies.Qualifications:

Required:

6+ years of experience in pharmaceutical advertising and promotion compliance.Proven track record in leading or supporting pharmaceutical product launches, particularly in rare diseases.Ability to provide practical, risk-based regulatory guidance in cross-functional environments.Proficient understanding of U.S. regulatory requirements, medical terminology, and FDA advertising standards.Solid grasp of pharmaceutical industry drug development processes.Preferred:

8+ years in pharmaceutical advertising and promotion compliance activities.Experience in neurology or other specialty areas preferred.History of interacting with OPDP for launch programs.Experience supporting investigational or accelerated approval products is a plus.Leadership qualities in mentoring and developing promotion compliance teams.Strong communication skills and ability to work across multifunctional groups.Excellent computer skills including proficiency with MS Office applications and promotional compliance software.The comprehensive benefits package includes medical, dental, vision, prescription drug coverage, and more. Join us in our mission at Otsuka to make a meaningful impact. We prioritize diverse candidates and support equal opportunity for employment for all individuals, regardless of race, gender, age, or background. If you require accommodations during the application process, please reach out to our dedicated support email.