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.
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
- 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.
Educational Requirements:
- Master’s degree in Life Science or related 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.
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. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. 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.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
