Madrigal Pharmaceuticals is hiring: Vice President, Global Promotional Advertisi
Madrigal Pharmaceuticals, Conshohocken, Montgomery County, United States
Vice President, Global Promotional Advertising and Regulatory Affairs
Join Madrigal Pharmaceuticals as the Executive Leader who will develop, execute, and protect the company’s global regulatory strategy for advertising, promotion, and scientific‑exchange communications. The role ensures that all promotional materials comply with FDA regulations, enforcement precedent, industry codes of practice, and international laws while enabling commercial objectives.
Key Responsibilities
- Develop and lead the global regulatory advertising & promotion strategy aligned with brand plans and overall regulatory strategy.
- Serve as the subject‑matter expert for all promotional communications—advertising, sales aids, digital channels, medical education, disease awareness, conference exhibits, and scientific exchange materials—ensuring compliance with applicable laws and internal policies.
- Manage and mentor staff through the promotional review process, including concepts, claims, safety/risk language, and labeling consistency.
- Act as primary liaison with regulatory agencies, including submissions (Form 2253), advisory requests, and responses to enforcement letters or competitor complaints.
- Provide strategic regulatory advice and risk‑based assessments to cross‑functional stakeholders, facilitating timely and compliant promotional launch campaigns.
- Develop, implement, and maintain SOPs, guidelines, training programs, quality metrics, and dashboards for the review process, ensuring operational excellence and continuous improvement.
- Monitor and interpret regulatory developments and proactively update the business on implications for promotional communications and risk mitigation.
- Mentor, build, and lead the regulatory advertising & promotion team, fostering expertise, collaboration, and stakeholder engagement.
- Support global/regional harmonization of advertising & promotion regulatory framework and ensure consistency across cross‑border materials.
- Ensure appropriate database/record‑keeping for promotional materials, including submissions, approvals, regulatory correspondence, internal reviews, and audit readiness.
- Other duties as assigned.
Required & Desired Qualifications
- Bachelor’s degree in Life Sciences required; advanced degree (PharmD, PhD, MS) strongly preferred.
- 20+ years of relevant experience in regulatory affairs advertising & promotion review, general regulatory strategy, labeling knowledge, and commercial compliance; minimum 10–15 years in the pharmaceutical/biologics industry.
- Deep knowledge of U.S. FDA advertising & promotion regulations, including OPDP, Form 2253 submissions, enforcement letters, and familiarity with global regulatory codes of practice.
- Demonstrated cross‑functional matrixed collaboration with Commercial, Medical Affairs, Legal/Compliance, Regulatory, and other stakeholders, influencing without direct authority.
- Strong strategic, analytical, and risk‑management mindset: interpret complex regulatory standards, provide clear positions, and support launch assets and marketed brands.
- Excellent communication skills; articulate regulatory rationale, prepare senior‑management correspondence, and deliver training.
- Experience with promotional review systems (e.g., Veeva PromoMats) and metrics/tracking of review performance is preferred.
- Leadership and team‑building experience preferred, with ability to mentor and develop regulatory professionals.
Preferred/Desirable
- Experience in high‑regulatory scrutiny therapeutic areas (oncology, rare diseases, biologics) or major product launches.
- Global/regional experience in advertising & promotion regulatory matters or global brand support.
- Experience working with regulatory authorities on advisory comments, competitor complaints, or enforcement issues.
- Experience optimizing promotional review processes, SOPs, dashboards, and training programs to drive operational efficiency.
- Experience supporting digital/multi‑channel promotional communications in a regulatory context.
Benefits & Compensation
Base salary: $316,000–$386,000 per year (based on qualifications and market). Employees are eligible for a competitive total rewards package, including bonus, equity, comprehensive health benefits, 401(k) plan, paid time off, and mental health resources such as Employee Assistance Program.
Madrigal provides generous equity opportunities and a comprehensive benefits suite. All full‑time employees receive equity, health, dental, vision, life/disability insurance, and other benefits in accordance with applicable laws.
EEO Statement
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.