Stephanie M Byrd, PhD, RAC is a Principal Clinical Research Scientist at Syner-G Biopharma Group. Prior to joining Syner-G Biopharma Group, Steph gained experience in medical writing with a focus on pharmacokinetic (PK) reports and associated IND and NDA modules, project management, and regulatory affairs at her previous role at Nuventra Pharma Sciences. Prior to this she was an analytical development specialist at Medicago where she gained experience in Phase 1 and Phase 2 drug development for plant-based vaccines in a GMP setting.

Steph’s primary responsibilities at Syner-G BioPharma Group currently include writing Clinical Study Reports (CSRs), study protocols, IBs/IB updates, submission documents, briefing documents, and safety narratives and project management (PM) tasks that accompany these projects. Overall, Steph has more than 12 years of experience in medical and academic writing as well as in drug development and clinical research. Her clinical writing and regulatory experience ranges across all stages of drug development (preclinical through post marketing) and spans a variety of therapeutic areas including autoimmune diseases, central nervous system, infectious diseases, metabolic and endocrine disorders, oncology, ophthalmology, orphan disease, rheumatology, and respiratory diseases.

Steph received a BS in biology from Wake Forest University and a PhD in plant biology with a minor in biotechnology from North Carolina State University in 2013. She earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS) in 2019.