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. 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:

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