Bachelor's degree in life science or equivalent; advanced degree preferred.
Minimum of 7 years' experience in the pharmaceutical industry, focusing on advertising and promotion.
Experience in dermatology is preferred.
Strong understanding of regulatory advertising and promotion regulations.
Excellent negotiation and communication skills, both oral and written.
Ability to collaborate with senior leadership across the organization.
Experience interacting with the Food and Drug Administration.
Responsibilities
Review and approve US Dermatology promotional materials daily.
Ensure promotional materials are accurate, truthful, and compliant with regulations.
Liaise with the FDA regarding advertising and promotional materials.
Communicate regulatory issues with Senior Marketing and other departments.
Drive promotional regulatory strategy in collaboration with various teams.
Develop and implement departmental strategic initiatives.
Mentor team members and provide promotional regulatory training.
Benefits
Retirement savings plan.
Paid vacation and holiday time.
Paid caregiver/parental and medical leave.
Health benefits including medical, prescription drug, dental, and vision coverage.
Full Job Description
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
Secondary Language(s) Job Description
US and PR Residents Only
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
About Organon
Organon is a global pharmaceutical company that develops and manufactures prescription medicines, vaccines, and animal health products. The company is focused on improving the health and well-being of people and animals around the world. Organon has a diverse portfolio of products that includes treatments for women's health, oncology, and fertility. The company is committed to sustainability and has set ambitious goals to reduce its environmental impact and improve access to healthcare in underserved communities.
