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. 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 developmentDeep 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. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
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