VP/Sr. VP of Advertising & Promotional Review

ProPharma • Washington, DC

2d

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. 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. 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. Providing 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. Other duties as assigned.

Requirements

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

Responsibilities

• 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.
• 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.
• Regulatory/Medical/Legal promotional review and labeling services leadership and roadmap development for process improvement and guidance leveraging appropriate resources and knowledge.
• Providing 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.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive