Propharmagroup
VP/Sr. VP of Advertising & Promotional Review
United States · Vp
Sponsorship not specifiedDetected 30 days ago
Product ManagementProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceMedical DevicesResearchLeadershipCommunicationCollaborationRegulatory Affairs
About the role
- 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.
Responsibilities
- 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.
- ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
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.
Nice to have
- Master's degree in Life Science or related is required, higher degree is preferred.
Skills
- 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.
- 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.
- Necessary Skills and Abilities:
Benefits
- Providing strategic input necessary for RPR & LS deliverables as well as formal health authority interactions and communications.
- Regulatory/Medical/Legal promotional review and labeling services leadership and roadmap development for process improvement and guidance leveraging appropriate resources and knowledge.
- Contributes regulatory affairs/medical/legal thought leadership and innovation.
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