Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas. On the Clinical electronic Structured Harmonised Protocol (CeSHarP) M11 EWG, Mary Lynn is the Deputy Topic Lead for PhRMA. She participates in the TransCelerate Clinical Content & Reuse (CC&R) workstream, where she is the lead for Strategic Engagement. Additionally, Mary Lynn has a PhD in Pharmacology and over 10 years of experience in Neuroscience research and drug discovery.