Expert medical writer for biotech, pharmaceutical, medical device, and related industries. Deep experience with regulatory (ICH-compliant) submissions (eg, eCTDs, BLAs, NDAs, PMAs, and INDs); manuscripts; GXP documents, audit reports; document QC services (clinical and CMC documents); medical writing infrastructure (eg, templates, style guides, checklists, SOPs, guidelines/work practices, and project management methods); and document editing, proofreading, reviewing, and formatting (including automatic Table of Contents, figure and table captions, hyperlinks, bookmarks, and in-text cross-references). Other experience includes web content, patient education brochures, and newsletters.