Director of Dermatology Ad Promotion & Compliance

Organon Comercializadora S de RL de C.V; Harmonville (PA); Vor Ort; USD 152.000 - 259.000; Vollzeit

Zusammenfassung

Organon seeks an experienced Regulatory Affairs professional to lead day-to-day review and approval of US dermatology promotional materials, ensuring accuracy, fairness, and compliance with labeling and internal policies. The role serves as a liaison with the FDA on promotional matters and drives regulatory strategy across Commercial, PRC, Global Regulatory Affairs and Medical Affairs.

The position involves collaboration with senior leadership, participation in labeling and product development

Qualifikationen

• 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.

Aufgaben

• Day-to-day review and approval of US Dermatology promotional materials.
• Materials must be accurate, truthful, not misleading, fair and balanced, consistent with labeling, well-substantiated by current evidence, and compliant with policies.
• Serve as liaison with FDA on advertising and promotional materials issues.
• Communicate and manage regulatory issues with Senior Marketing, PRC, Global Regulatory Affairs, Medical Affairs and Product labeling.
• Drive promotional regulatory strategy with Commercial, PRC, Global Regulatory Liaisons, Medical Affairs and Product Labeling; participate in labeling and product development meetings.
• Work independently and escalate to Senior Management when needed; review and define standards for promotion across platforms.
• Develop and implement departmental strategic initiatives; provide risk assessment for new commercial initiatives.
• Engage with Agency Contacts (OPDP, APLB) and associations to improve the regulatory environment.
• Enhance collaboration across the organization and maintain varied disciplines across review committees.
• Provide mentoring and promotional regulatory training to team members.
• Operate independently, knowing when to consult leadership concerning risks.

Kenntnisse

Negotiation

Communication

Leadership collaboration

Dermatology experience

Ausbildung

Bachelor's degree in life science or equivalent

Advanced degree preferred

Jobbeschreibung

Organon seeks an experienced Regulatory Affairs professional to lead day-to-day review and approval of US dermatology promotional materials, ensuring accuracy, fairness, and compliance with labeling and internal policies. The role serves as a liaison with the FDA on promotional matters and drives regulatory strategy across Commercial, PRC, Global Regulatory Affairs and Medical Affairs.

The position involves collaboration with senior leadership, participation in labeling and product development