[Hiring] Director, US Advertising and Promotion @The businesses of Merck KGaA, Darmstadt, Germany

Role Description

At the intersection of science, strategy, and compliance, this role offers a rare opportunity to shape how life-changing therapies are brought to patients through compliant, compelling promotion.

• The Director, US Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products.
• Accountable for the review, approval, and strategic oversight of promotional materials.
• Ensures compliance with applicable laws, regulations, and FDA guidance.
• Provides independent, expert regulatory counsel to cross-functional stakeholders.
• Enables the development of compliant and effective promotional strategies that support business objectives.
• Leads and represents Regulatory Affairs on Promotional Review Committees.
• Ensures U.S. promotional materials for prescription products meet regulatory requirements.
• Acts as the primary regulatory liaison to FDA promotional review divisions, including OPDP and APLB.
• Manages correspondence and addresses complex regulatory inquiries.
• Oversees submissions for advisory comment.
• Proposes innovative and compliant regulatory strategies and solutions to complex promotional concepts.
• Leads the strategic evaluation and regulatory positioning of proposed product claims for assets in development.
• Drives the development, implementation, and continuous improvement of advertising and promotion processes.
• Leads the assessment of evolving regulatory trends, guidance, and enforcement activities.
• Participates in labeling and global regulatory team discussions.
• Leads the development of regulatory strategy communications.
• Oversees interactions with OPDP and APLB.
• Designs and executes enterprise-wide training on promotional regulatory requirements.
• Collaborates closely with Marketing, Legal, Medical Affairs, Quality, and other stakeholders.
• Partners with Quality on internal audits and CAPAs.
• Provides coaching and informal mentorship to team members.

Qualifications

• Bachelor’s degree in a science or health-related discipline; advanced degree (PhD, MD, MS, or PharmD) strongly preferred.
• Minimum 8+ years of pharmaceutical industry or related experience.
• Minimum of 5 years as a primary reviewer of advertising and promotional materials.
• In-depth knowledge of FDA regulations governing the development, review, and approval of prescription drug promotional materials.
• Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges.
• Strong diplomacy, interpersonal, and negotiation skills.

Requirements

• Experience leading or supporting drug promotion activities and product launches within a pharmaceutical or biopharmaceutical environment.
• Comprehensive understanding of the Regulatory Affairs landscape for prescription drugs.
• Demonstrated ability to lead enterprise-wide training initiatives.
• Excellent verbal and written communication skills.

Benefits

• Health insurance.
• Paid time off (PTO).
• Retirement contributions.
• Other perquisites.