Director, Advertising Promotion - Regulatory

9000 Organon LLC; Harmonville (PA); Presencial; USD 152.000 - 259.000; Tempo integral

Resumo da vaga

Organon LLC in the United States is seeking a senior Regulatory Affairs professional to lead day-to-day review and approval of dermatology promotional materials, ensuring truthfulness, balance, and compliance with labeling and evidence. The role partners with Senior Marketing, PRC, Global Regulatory Affairs, Medical Affairs and Product Labeling to shape strategy, raise issues to senior management, and mentor the team.

Requires 7+ years in pharma advertising and strong FDA interaction experience.

Qualificações

• Bachelor’s degree in life science or equivalent.
• Advanced degree preferred; dermatology experience preferred.
• 7+ years pharmaceutical advertising and promotion experience.
• Solid understanding of regulatory advertising and promotion regulations.
• Strong negotiation and written/oral communication skills.

Responsabilidades

• Review and approve US Dermatology promotional materials for accuracy and fairness.
• Coordinate with FDA on advertising and promotional issues.
• Communicate regulatory risks to Senior Management and cross-functional teams.
• Drive promotional regulatory strategy with key stakeholders.
• Participate in labeling and product development meetings.
• Mentee team members and provide regulatory training.
• Elevate issues to leadership when needed.
• Develop and implement departmental strategic initiatives.
• Support agency interactions and promote compliance.

Conhecimentos

FDA liaison

Regulatory advertising

Cross-functional collaboration

Leadership communication

Negotiation

Dermatology experience

Strategic planning

Formação

Bachelor's degree in life science

Advanced degree preferred

Descrição da vaga

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)

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

For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule 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.

Search Firm Representatives

Please Read Carefully Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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. 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. Annualized Salary Range (US) $152,300.00 - $259,200.00 Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status

Regular Relocation: No relocation VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements

Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.