Director, US Advertising and Promotion

Merck•Boston, MA

2d•Remote

About The Position

The Director, US Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products and is accountable for the review, approval, and strategic oversight of promotional materials. The Director ensures compliance with applicable laws, regulations, and FDA guidance while providing independent, expert regulatory counsel to cross-functional stakeholders. Operating with a high degree of autonomy, the role enables compliant and effective promotional strategies that support business objectives. The Director leads and represents Regulatory Affairs on Promotional Review Committees and serves as the primary regulatory liaison to FDA promotional review divisions, including OPDP and APLB. The role manages correspondence, responds to complex regulatory inquiries, and oversees submissions for advisory comment. It develops regulatory strategies for complex promotional concepts and leads strategic evaluation and positioning of proposed product claims for assets in development, including oversight of Important Safety Information and Brief Summary documents as appropriate. The role drives the development, implementation, and continuous improvement of advertising and promotion processes, standards, and standard operating procedures. It assesses evolving regulatory trends, guidance, and enforcement activities; participates in labeling and global regulatory discussions; leads regulatory strategy communications, including responses to FDA action letters; and oversees enterprise-wide training on promotional regulatory requirements. As a strategic leader and subject matter expert in U.S. promotional regulations, the Director collaborates with Marketing, Legal, Medical Affairs, Quality, and other stakeholders. The role partners with Quality on internal audits and CAPAs and provides coaching and informal mentorship to team members, including onboarding support for new hires.

Requirements

Bachelor’s degree in a science or health-related discipline.
At least 8 years of pharmaceutical industry or related experience.
At least 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, including OPDP and APLB processes.
Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges while balancing business objectives with regulatory risk.
Strong diplomacy, interpersonal, and negotiation skills, with a track record as a consensus builder across cross-functional teams.
Must be eligible to work in the United States; this role does not offer work authorization sponsorship.

Nice To Haves

Advanced degree such as a PhD, MD, MS, or PharmD.
Experience leading or supporting drug promotion activities and product launches in a pharmaceutical or biopharmaceutical environment.
Comprehensive understanding of the Regulatory Affairs landscape for prescription drugs, including labeling strategy and clinical development alignment.
Demonstrated ability to lead enterprise-wide training initiatives and foster continuous improvement and regulatory compliance.
Excellent verbal and written communication skills, including the ability to translate complex regulatory concepts for diverse audiences.

Responsibilities

Serve as the U.S. promotional regulatory lead for assigned products and oversee review, approval, and strategic direction of promotional materials.
Ensure promotional materials comply with applicable laws, regulations, and FDA guidance.
Provide independent regulatory counsel and develop compliant promotional strategies that support business objectives.
Lead and represent Regulatory Affairs on Promotional Review Committees.
Act as the primary regulatory liaison to FDA promotional review divisions, including OPDP and APLB; manage correspondence and complex inquiries and oversee submissions for advisory comment.
Develop regulatory strategies and solutions for complex promotional concepts while balancing business objectives and regulatory risk.
Lead evaluation and regulatory positioning of proposed product claims for assets in development, including oversight of Important Safety Information and Brief Summary documents as appropriate.
Develop, implement, and continuously improve advertising and promotion processes, standards, and standard operating procedures.
Assess evolving regulatory trends, guidance, and enforcement activities and advise Regulatory Affairs teams, review committees, and cross-functional stakeholders.
Participate in labeling and global regulatory discussions to align clinical development and labeling strategies with anticipated promotional claims and messaging.
Lead regulatory strategy communications, including responses to FDA action letters, and oversee interactions with OPDP and APLB.
Oversee the design and execution of enterprise-wide training on promotional regulatory requirements.
Collaborate with Marketing, Legal, Medical Affairs, Quality, and other stakeholders to support compliant promotional execution.
Partner with Quality on internal audits and CAPAs, providing regulatory leadership and driving continuous improvement.
Provide coaching and informal mentorship to team members, including onboarding support for new hires.