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Bridging Science and Compliance: The Synergy between Medical Writing and Regulatory Affairs

Medical Writing (MW) and Regulatory Affairs (RA) are closely related fields but serve distinct roles in the lifecycle of clinical research and drug development. The synergy between medical writing and regulatory affairs is crucial. Medical writers produce the comprehensive documents needed for regulatory submissions, while RA professionals oversee the submission process and ensure compliance with regulatory standards. Effective collaboration ensures that documentation is not only scientifically accurate but also meets regulatory expectations and facilitates the approval process. This session is best suited for those individuals interested in learning more about the roles that MW and RA play in the landscape of clinical development. The objectives of the session include discussing the various document types that MW and RA support and how these two functional groups work together to ensure that clinical research data is communicated effectively and that new therapies can advance through the regulatory process both efficiently and ethically. 

Speaker: Stephanie Byrd, PhD, RAC 

Stephanie Byrd, PhD, RAC is a Principal Clinical Research Scientist at Syner-G Biopharma Group, a leading provider of CMC, Regulatory Affairs, and Medical Writing solutions for biopharma. Her primary responsibilities as a MW include authoring CSRs, study protocols and protocol amendments, IBs/IB updates, Briefing Documents, submission documents, and regulatory responses and PM tasks that accompany these projects. In addition, Steph works closely with RA (client or internal) to ensure clinical documents within a submission meet the regulations and conform to submission standards. Steph received her PhD in Plant Biology with a minor in Biotechnology from North Carolina State University and studied and received her RAC in 2019.