Interview with Dr. Keagen Hadley – Episode 444

In today’s interview, Dr. Keagen Hadley describes how he built a flexible and lucrative nonclinical career in regulatory medical writing.

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He outlines how clinicians can break into the field even without pharma experience by learning the drug development lifecycle, mastering essential documents, and presenting their background effectively.

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What Regulatory Writing Involves

Rather than focusing on marketing copy or patient education, regulatory medical writing centers on the core documents that move drugs and devices through development: study protocols, investigator brochures, clinical study reports, and related submissions.

Keagen explains how writers translate study designs, data, and safety information into clear, consistent documents that meet strict regulatory and ICH guidelines, and how they collaborate with clinicians, statisticians, and project managers across a trial.

He also highlights the appeal of the work: structured, detail-oriented tasks, predictable timelines, fully remote setups, and the chance to influence new therapies at a systems level rather than through individual patient visits.

Starting a Writing Business

After building experience inside a CRO (contract research organization), Dr. Hadley transitioned into consulting so he could choose his projects and control his schedule.

He emphasizes getting comfortable with the “meat and potatoes” of regulatory writing, protocols, investigator brochures, and clinical study reports, and pairing that with a solid grasp of the drug-development pathway and applicable regulations.

Honing Your Skills

To move in this direction, he points to sharpening writing and Microsoft Word skills, and learning GxP basics (“Good X Practices,” an acronym representing a set of quality guidelines and regulations in the pharmaceutical industry, where “x” is a placeholder for specific fields).

He recommends learning to network on LinkedIn, and joining organizations like AMWA (American Medical Writers Association) and RAPS (Regulatory Affairs Professionals Society), And he offers his free resource, the Clinician’s Guide to Regulatory Writing Substack, to build knowledge, credibility, and client relationships.

Summary

This episode lays out a realistic path from clinical or research work into regulatory medical writing. And he explains how strong communication skills and comfort with structure can translate into a part-time remote career and, eventually, lucrative independent consulting. 

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