roshni sethi

* Serve as the FDA contact for two oncology products and maintain their marketing applications. * Prepare post-marketing submissions and work with Regulatory Operations to publish submissions in eCTD format. * Initiate and review labeling and packaging updates in accordance with appropriate regulations and guidelines. * Perform final regulatory reviews for all promotional materials and manage 2253 submissions to OPDP. * Lead Medical Review Committee meetings and ensure claims across medical and promotional materials are accurate and consistent.

* Managed the creation of marketing collateral from concept to completion. * Analyzed industry articles to identify and extract relevant data to incorporate into effective marketing materials for the sales force. * Worked cross-functionally with Research and Development, Marketing Communications, and Medical Education to determine key messages to deliver through multiple media channels. * Collaborated with Sales and Surgeons to gather feedback on whether the information present in marketing material was fundamental and effective. * Utilized Veeva Vault exhaustively to expedite promotional review process. * Assisted product manager with designing and conducting surveys to determine product perceptions, content impact, and competitor data.

* Created and presented cost saving analysis for small to medium sized business clients, providing assurance of the best services available. * Initiated and maintained client relationships throughout the sales cycle, resulting in client loyalty. * Implemented plans based on client feedback to ensure client satisfaction. * Shared successful sales strategies to contribute to team growth.