Director, Advertising Promotion - Regulatory

Responsibilities

• Responsible for day-to-day review and approval of US Dermatology promotional materials. 
• Ensure materials are accurate, truthful, and not misleading, presented in a fair and balanced manner, consistent with product labeling, well-substantiated by current and scientifically valid evidence, adherent to applicable advertising and promotion standards, and comply with all internal and external policies and procedures. 
• Serve as a liaison with Food and Drug Administration on issues related to advertising and promotional materials.​
• Effectively communicate and manage potential regulatory issues and concerns with Senior Marketing, Promotional Review Committee (PRC), Global Regulatory Affairs, Medical Affairs and Product labeling.
• Drive promotional regulatory strategy in collaboration with Commercial, Promotional Review Committee (PRC), Global Regulatory Liaisons, Medical Affairs and Product Labeling. Actively participate in labeling and product development meetings.
• Work independently and recognize when issues should be elevated to Senior Management. Review and define standards for promotion, including traditional and emerging promotional platforms.
• Develop and implement departmental strategic initiatives. Serves as resource to internal leadership on risk assessment for new commercial initiatives.
• Engage in appropriate activities to improve the regulatory environment through Agency Contacts: OPDP, APLB and associations as appropriate.
• Enhance collaboration across the organization while developing and maintaining varied disciplines across multiple review committees.
• Provide mentoring and promotional regulatory training to team members.
• Operate independently, with recognition of when to consult departmental leadership concerning risks.

Required Education, Experience & Skills

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

Secondary Language(s) Job Description

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

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