Joanne Northcutt

Joanne Northcutt, Ph.D. has extensive work experience in medical writing and consulting. Since 2012, they have served as the President/Owner of Northcutt Consulting, LLC, where they specialize in writing, editing, and reviewing regulatory documents for clinical trials. Joanne has also written protocol submissions for IRB and FDA submissions.

Joanne has held various roles at different companies, including being an Associate Director of Medical Writing at both Keros Therapeutics and Praxis Precision Medicines, Inc. In these positions, they were responsible for preparing medical and regulatory documents for submissions to health authorities such as the FDA. Joanne collaborated with cross-functional team members and provided leadership to ensure the completion of required documents.

Prior to these roles, Joanne worked as a Principal Medical Writer at PRA Health Sciences and as a Medical Writer at Alkermes. Joanne also served as a Medical Writer at Athersys and The Med Writers, where they wrote, edited, and reviewed regulatory documents and submissions for IRB and FDA.

Additionally, Joanne has experience as a National Language Champion/Rater Trainer Consultant at Bracket and as a Regulatory Medical Writer and Editor at Global Medical Writing and Translation. Their responsibilities included writing, editing, and reviewing various regulatory documents and publications.

Before their pharmaceutical industry work, Joanne worked at the Florida Clinical Research Center as an Investigator, Assistant Site Director, and Clinical Rater. Joanne managed a clinical research site, supervised study site staff, and wrote and reviewed regulatory documents, journal manuscripts, and training modules.

Overall, Joanne Northcutt, Ph.D. has a diverse background in medical writing and consulting, specializing in the preparation of regulatory documents for clinical trials and submissions to health authorities.

Joanne Northcutt, Ph.D., possesses an extensive educational background in the field of psychology. In 2004, they completed their Ph.D. in Psychology from The University of Sheffield, following four years of research and study. Prior to that, they obtained a Bachelor of Science degree in Psychology from the University of Warwick in 2000.

In addition to their formal education, Joanne Northcutt has also earned several certifications related to clinical research. In 2007, they achieved the title of Certified Clinical Research Professional from The Society of Clinical Research Associates. Later, in 2015, they obtained the Certified Principal Investigator (CPI®) credential from the Association of Clinical Research Professionals. These certifications further support their expertise and qualifications in the field of clinical research.