VP/Sr. VP of Advertising & Promotional Review

Job Summary

The Vice President, Promotional Review & Labeling Services (“RPR & LS”) is responsible for:

• Leading in the management of RPR & LS associated with drugs, biologics, combination products, OTC, Medical Devices, etc.
• Providing compliance and regulatory advisory services for pharmaceutical, medical device and other relevant companies.
• Pricing and regulatory advisory services for pharmaceutical, medical device and other relevant companies.
• Partnering with C-suite Executives, Compliance Officers, General Counsel Offices, Internal Auditors, Board Committees and Regulatory, Clinical, Medical and Regulatory Affairs Functions within client companies.
• Providing strategic input necessary for RPR & LS deliverables as well as formal health authority interactions and communications.
• Collaborating with clients on all matters of RPR & LS and serve as the executive point person on assigned projects.
• Working on special projects as assigned by RPR & LS Leadership.

Essential Functions

Regulatory/Medical/Legal promotional review and labeling services leadership and roadmap development for process improvement and guidance leveraging appropriate resources and knowledge.

• Provides necessary guidance to help develop appropriate infrastructure in support of product communications, product development during all phases of a product’s life cycle.
• Identify expert review support for companies at various stages of development, including direction for appropriate promotional tactics that are aligned with FDA requirements.
• Contributes regulatory affairs/medical/legal thought leadership and innovation.
• Contribute significantly to a high-quality work product, ensuring on time and within budget delivery.

Necessary Skills And 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.
• Strong experience in leading activities necessary for promotional OPDP submissions and new product labeling development.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Effectively manages deadlines, multi-tasks, and remains calm under pressure.
• Experience leading cross-functional teams, directing the efforts of subject matter experts as the project dictates.
• Demonstrated ability to develop positive relationships and collaborations.
• Excellent oral and written communication skills with cross-functional collaboration skills.
• Strong analytical skills; a strategic thinker, planner and implementer.
• Proven ability to provide strategic direction and innovative, forward thinking.

Educational Requirements

A Master’s degree in Life Science or related field is required, higher degree is preferred.

Experience Requirements

• 15+ years in positions of progressive leadership in RPR & LS within regulated pharmaceutical / biotech drug development company(ies), consulting firm, CRO or FDA.
• Experience leading teams of technical professionals.