Kelly Smith

Kelly is a Senior Director of Global Submissions at Certara and has over 20 years of industry experience as a Regulatory Medical Writer. After her PhD in Biomedical Sciences, Kelly transitioned into Regulatory Medical Writing and has worked her entire career at specialist medical writing service providers, working with many different clients from small to large pharmaceutical companies across multiple therapeutic areas. During her career, Kelly has led a wide range of medical writing projects, encompassing submission-level, study-level and drug safety documents, and works on both non-clinical and clinical documents. Kelly has been responsible for training numerous medical writers during her career and, in her current role as one of the Submission Leads at Certara, she continues to author documents, but also advises clients on best practices for writing high-quality submission-ready regulatory documents.