Madison Hedrick, MA

Madison Hedrick, MA is a distinguished regulatory affairs and medical writing executive whose career spans pharmaceuticals, biologics, medical devices, and diagnostics. With dual degrees in Professional & Technical Writing from the University of Arkansas at Little Rock, Madison has become a trusted authority in global healthcare innovation, delivering high‑impact regulatory submissions and clinical documentation that shape patient access and industry standards worldwide. As a Scientist III and Senior Medical Writer for companies including Cardinal Health, Artivion, J&J, Eli Lilly, Regeneron, and others, Madison has directed global submissions to the FDA, EMA, and international authorities, authoring NDAs, CMC documentation, Clinical Study Reports, and EU MDR‑compliant deliverables. Her leadership has secured specialized designations such as PRIME and Breakthrough Therapy, while guiding MDR transition projects and inspection readiness for Class I–III devices. Madison is a recognized leader in professional societies, having served as President of the American Medical Writers Association Southeast Chapter, contributed to the AMWA Conference Committee, and actively engaged with the Regulatory Affairs Professionals Society (RAPS) and the Society of Clinical Research Associates (SOCRA). These roles underscore her influence in shaping best practices across regulatory affairs and clinical research. Beyond corporate leadership, Madison is a prolific author of courses, blogs, CME materials, and peer‑reviewed publications, translating complex regulatory science into accessible, actionable tools. She has mentored junior professionals, trained cross‑functional teams, and built entry pathways for early‑career medical writers, reinforcing her commitment to education and empowerment. Her service on the UA Little Rock Alumni Board of Directors highlights her dedication to advancing her alma mater’s mission and showcasing the transformative power of technical writing in global healthcare. Madison Hedrick embodies the values of the Worldwide Women’s Association—excellence, perseverance, and leadership—demonstrating how regulatory expertise and scientific communication can elevate industries, communities, and future generations of women leaders.