Director, Advertising Promotion - Regulatory

Organon Comercializadora S de RL de C.V; Harmonville (PA); On-site; USD 152,000 - 259,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Negotiation

Communication

Leadership collaboration

Dermatology experience

Education

Bachelor's degree in life science or equivalent

Advanced degree preferred

Job description

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

Who We Are:

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.

US and PR Residents Only

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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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Applicable to United States Positions Only:

Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below.

Annualized Salary Range (US) $152,300.00 - $259,200.00

Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Please Note: Pay ranges are specific to local market