Director, Advertising Promotion - Regulatory

Organon

Harmonville (PA)

Presencial

USD 152.000 - 259.000

Tempo integral

Há 2 dias

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Resumo da vaga

Organon is seeking a Senior Regulatory Affairs professional to oversee day-to-day review and approval of US Dermatology promotional materials. You will ensure materials are accurate, balanced, and supported by current evidence, while coordinating with FDA on advertising issues.

You will drive regulatory strategy with cross-functional teams, participate in labeling and product development meetings, and mentor staff.

Qualificações

Bachelor's degree in life science or equivalent; advanced degree preferred.
Experience in dermatology is preferred.
Minimum 7 years’ pharmaceutical experience with advertising/promo.
Strong understanding of regulatory advertising and promotion regulations.
Excellent negotiation and communication skills; able to work with senior leadership.
Experience interacting with the FDA.

Responsabilidades

Review and approve day-to-day US Dermatology promotional materials.
Ensure materials are accurate, truthful, and not misleading per labeling and evidence.
Serve as liaison with FDA on advertising/promotional issues.
Communicate regulatory risks to Senior Marketing, PRC, Global Regulatory, Medical Affairs.
Drive regulatory strategy in collaboration with Commercial, PRC, Global Regulatory Liaisons.
Participate in labeling and product development meetings.
Develop and implement departmental strategic initiatives; advise leadership on risk.
Improve regulatory environment through agency contacts and associations.
Foster cross-organizational collaboration across review committees.
Provide regulatory training to team members.

Conhecimentos

Regulatory advertising

Negotiation

Communication skills

Leadership collaboration

FDA interactions

Dermatology experience

Formação

Bachelor’s degree in life science

Advanced degree preferred

Descrição da vaga

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.

Responsibilities

Job Description

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

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:

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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.

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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.