Joanne Northcutt
Director Head of Medical Writing @Keros Therapeutics
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WORK HISTORY
Director Head of Medical Writing @Keros Therapeutics
EDUCATION
University of Warwick
Bachelor of Science, Psychology
The University of Sheffield
PhD, Psychology
SKILLS
ABOUT JOANNE NORTHCUTT
Regulatory and Medical Writing Expertise- FDA submissions including clinical protocols, Breakthrough Therapy Designation Requests, Orphan Drug Designation Requests, patient narratives, study summaries, and QC- Company Style Guide for regulatory documents and submissions- Informed Consent and Assent Forms- Journal manuscripts, textbook chapters, briefings/slide sets, posters, abstracts, literature reviews,SOPs, CME/training modules, web site content, and news articles/blogs- Writing, editing, and reviewing scientific journal manuscripts and publications- Editing for clinical researchers or authors whose first language is not English, for scientific manuscripts and publications. 20 years of regulatory and medical writing experience in pharmaceutical Phase I-IV clinical research trials. 20 years of experience in pharmaceutical Phase I-IV clinical research trials as an Investigator, Site Director, and Clinical Rater. A strong publication record in peer-reviewed medical journals and literature. A unique combination of medical regulatory writing expertise, extensive clinical trial management experience, clinical care rating / interviewing and clinical skills, management experience, and extensive psychiatric knowledge. Expertise: Alcohol Dependence, Alzheimer’s Disease, Anxiety Disorders, Attention Deficit Hyperactivity Disorder, Autistic Spectrum Disorders, Bipolar Disorder, Depressive Disorder, Fibromyalgia, Insomnia, Migraine, Mild Cognitive Impairment, Neurology, Oncology, Post-Traumatic Stress Disorder, Psychotic Disorders, Smoking Cessation, Substance Use Disorders, Urology. Specialties: Regulatory Writing; Technical Writing; Medical Writing and Editing; Child and Adult Psychology; Clinical Research Management; Clinical Rating Scales; Clinical Interviewing.
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