Kathryn Nelson Emily
I am a Mayo Clinic-trained medical writer and editor with more than 25 years of experience in writing and editing regulatory documents and complex manuscripts in the pharmaceutical industry and clinical research.
I am certified by the Board of Editors in the Life Sciences as an Editor in the Life Sciences (ELS) and have earned the American Medical Writers Association (AMWA) Core Curriculum and Advanced Pharmaceutical Certificates.
My services include:
Regulatory writing and editing: IND Investigator Brochure (IB), study protocol, informed consent form (ICF), clinical study report (CSR); New Drug Application (NDA) clinical summaries for Module 2 (2.2, 2.4, 2.5, 2.6, 2.7), Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), Initial Pediatric Study Plan (IPSP), briefing books etc.
Medical writing and editing – journal manuscripts: author’s editing, developmental editing, analytical editing, substantive editing, copy editing, ESL editing (for authors whose first language is not English)
Cell phone: 904-891-9253
Years in the field: 25
Years freelancing: 17