Michael Narouz

About Michael Narouz

Review serious and non-serious adverse event reports for marketed and investigational…

Experience

1. Global Labeling Manager

   Novartis

   Sep 2021 — Present

   Responsible for the maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned Novartis Innovative Medicines products. Provide strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members in maintaining core labeling documents and handling HA or CO labeling queries for assigned products. • Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products. • Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations. • Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries • Interact with COs to ensure timely implementation of global labeling changes in local product information, and ensure international consistency and compliance with the CDS. • Contribute to RA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products. • Contribute to/lead presentations on labeling related topics for the assigned products at relevant board/forum/committee (e.g, MSRB, PSB). • Prepare and/or review PSUR RA input for assigned products. • Review and release International Package Leaflets for assigned products. • Contribute to global labeling management and continuous improvement initiatives. • Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics. • Represent GL during audits and inspections.