Joanne Northcutt, PhD is a regulatory and medical writer with over 15 years of experience in pharmaceutical Phase I-IV clinical trials. Services: Write, edit, and review fully ICH-compliant regulatory FDA Investigational New Drug (IND) and Orphan Drug Designation Request (ODDR) applications and submissions, clinical study protocols and amendments, annual reports, synopses / summaries, informed consent forms (ICFs), patient narratives, journal manuscripts, textbook chapters, briefings/slide sets, posters, abstracts, literature reviews, SOPs, CME/training modules, web site content, news articles/blogs; Ghost writing, and editing for scientific journal articles, books, and other publications. Medical Writing Skills: Therapeutic areas of expertise: Phase I-IV; 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.