Director, Advertising Promotion - Regulatory

Organon • Florham Park, NJ

1d • $152,300 - $259,200

About The Position

The Director, Advertising Promotion - Regulatory is responsible for the day-to-day review and approval of U.S. Dermatology promotional materials. The role ensures materials are accurate, truthful, not misleading, fair and balanced, consistent with product labeling, supported by current and scientifically valid evidence, and compliant with applicable standards and internal and external policies and procedures.

The Director serves as a liaison with the Food and Drug Administration on advertising and promotional matters and works with senior marketing, the Promotional Review Committee, Global Regulatory Affairs, Medical Affairs, and Product Labeling to address regulatory issues and develop promotional strategy. The position also contributes to labeling and product development meetings, sets standards for promotion across traditional and emerging platforms, and advises internal leadership on risk related to new commercial initiatives.

The role develops and implements departmental strategic initiatives, engages with relevant agencies and associations to improve the regulatory environment, promotes cross-organizational collaboration, and provides mentoring and promotional regulatory training to team members. It requires independent judgment, including knowing when to consult departmental leadership or elevate issues to senior management.

Requirements

• Bachelor’s degree in life science or equivalent.
• Minimum of 7 years of pharmaceutical experience, including significant advertising and promotion expertise.
• Solid understanding of regulatory advertising and promotion regulations.
• Strong oral and written negotiation and communication skills.
• Ability to work with senior leadership across the organization.
• Experience interacting with the Food and Drug Administration.

Nice To Haves

• Advanced degree.
• Experience in dermatology.

Responsibilities

• Review and approve U.S. Dermatology promotional materials on a day-to-day basis.
• Ensure promotional materials are accurate, truthful, not misleading, fair and balanced, consistent with product labeling, well-substantiated by current and scientifically valid evidence, and compliant with applicable standards and policies.
• Serve as a liaison with the Food and Drug Administration on issues related to advertising and promotional materials.
• Communicate and manage potential regulatory issues and concerns with Senior Marketing, the Promotional Review Committee, Global Regulatory Affairs, Medical Affairs, and Product Labeling.
• Drive promotional regulatory strategy in collaboration with Commercial, the Promotional Review Committee, Global Regulatory Liaisons, Medical Affairs, and Product Labeling.
• Participate in labeling and product development meetings.
• Work independently and recognize when issues should be elevated to Senior Management or discussed with departmental leadership.
• Review and define standards for promotion, including traditional and emerging promotional platforms.
• Develop and implement departmental strategic initiatives.
• Serve as a resource to internal leadership on risk assessment for new commercial initiatives.
• Engage with agencies, including OPDP and APLB, and associations as appropriate to improve the regulatory environment.
• Enhance collaboration across the organization and maintain varied disciplines across multiple review committees.
• Mentor team members and provide promotional regulatory training.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage in accordance with applicable plan terms and conditions.

What This Job Offers

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