Keagen Hadley

The Clinician's Guide to Regulatory Writing is a free weekly newsletter helping nurses, physicians, pharmacists, and allied health professionals transition into remote, flexible, and financially rewarding careers in regulatory medical writing. Started as a passion project to share everything I've learned over a decade in the field.

• Lead the development of regulatory and clinical documents • Help develop and implement global regulatory strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. • Continually expand therapeutic area knowledge and ensure strategic messaging and content of global regulatory dossiers. • Proactively anticipates and mitigates regulatory risks. • Ensures compliance with global regulatory requirements. • Demonstrate excellent understanding of drug development and leadership behaviors consistent with level. • Develops and implements acceleration strategies. • Manages projects and necessary documentation of regulatory strategies. • Regulatory intelligence projects as necessary to understand the competition and lead clients through the approval process.

Established the medical writing function for this fast-paced healthcare company. Wrote, edited, and led the development of multiple clinical regulatory documents within the neurologic and psychiatric indications. Collaborated with multidisciplinary teams and stakeholders to ensure alignment with quality and deadline requirements to produce optimal results.

Wrote and self-published my first book focused on assisting people who may be struggling with psychological issues related to ACL injuries. My book includes tips on managing stress and overcoming the mental hurdles of injury recovery. "Torn" became an Amazon bestseller in May of 2022.

Helped drive the medical writing function for this fast-paced healthcare company. Wrote, edited, and led the development of multiple clinical regulatory documents. Recruited and hired a high-performance creative team. Collaborated with stakeholders to ensure alignment with quality and deadline requirements.

Led all facets of this self-built medical writing consultancy serving a variety of healthcare organizations, including both large and small pharmaceutical companies and biotechs.