VP/Sr. VP of Advertising & Promotional Review

Job Summary

The Vice President, Promotional Review & Labeling Services (“RPR & LS”) is responsible for leading the management of RPR & LS associated with drugs, biologics, combination products, OTC, medical devices, and more. The role provides compliance and regulatory advisory services, partners with C‑suite executives, compliance officers, general counsel, internal auditors, board committees, and regulatory, clinical, medical and regulatory affairs functions within client companies. The executive point person on assigned projects delivers strategic input necessary for RPR & LS deliverables, formal health authority interactions and communications.
Responsibilities

Lead regulatory/medical/legal promotional review and labeling services leadership and roadmap development for process improvement and guidance.
Provide guidance to develop infrastructure supporting product communications and development during all phases of a product’s life cycle.
Identify expert review support for companies at various development stages, directing promotional tactics aligned with FDA requirements.
Contribute regulatory affairs/medical/legal thought leadership and innovation.
Ensure high‑quality work product, on‑time and within budget delivery.
Work on special projects as assigned by RPR & LS Leadership.
Skills & Abilities

Expert knowledge of the FDA Office of Prescription Drug Promotion regulations and pharmaceutical regulatory affairs and compliance guidelines on advertising and promotion, including product launches and labeling development.
Deep understanding of the advertising and promotion review and approval process.
Strong experience in leading activities necessary for promotional OPDP submissions and new product labeling development.
Demonstrated ability to manage multiple and diverse projects concurrently and meet deadlines under pressure.
Experience leading cross‑functional teams and directing subject‑matter experts.
Strong oral and written communication skills with cross‑functional collaboration.
Keen analytical skills, strategic thinker, planner and implementer.
Education

Master’s degree in Life Science or related field required; a higher degree preferred.
Experience

15+ years in progressive leadership roles in RPR & LS within regulated pharmaceutical/biotech drug development companies, consulting firms, CROs or the FDA.
Experience leading teams of technical professionals.
Equal Opportunity Employer

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion and provide a safe space for all employees to succeed.

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