Associate Director, Labeling and Promotional Materials - Remote

Overview

The Associate Director, Labeling and Promotional Materials at Pierre Fabre Pharmaceuticals will lead the labeling creation and approval process while managing promotional materials for a new oncology division.

In Short

• Lead labeling, advertising, and promotional activities for pharmaceutical products.
• Collaborate with Commercial, Medical Affairs, and Legal teams.
• Act as liaison to FDA's Office of Prescription Drug Promotion.
• Monitor regulations and analyze their relevance to promotional communications.
• Oversee U.S. labeling preparation and maintenance.
• Manage complex labeling negotiations with the FDA.
• Train cross-functional team members on U.S. labeling.
• Possess extensive experience in biotech/pharma and regulatory labeling.
• Experience with rare diseases and oncology is highly desirable.
• Embrace a fast-paced startup environment.

Requirements

• 10+ years in biotech/pharma with 6+ years in prescription drug labeling.
• Bachelor’s degree required; postgraduate degree or RAPS certification desirable.
• Experience in NDA/BLA labeling and negotiations.
• Experience in cross-functional projects.
• Scientific curiosity and creativity.
• Ability to handle business information compliantly.
• Passion for improving patient lives.

Benefits

• Competitive medical, dental, and vision plans.
• 401(k) plan and generous PTO policy.
• Paid parental leave and product discounts.
• Learning and development opportunities.
• Mental health and wellness programs.