Welcome

I am a medical writer with a PhD in chemistry and over 15 years of pharmaceutical experience, including 5 years of regulatory medical writing experience. I have written health authority question responses, NDA annual reports, briefing books, investigator brochures, clinical study reports (CSRs), clinical study protocols, breakthrough designation requests, orphan drug annual reports, clinical summary documents (eCTD modules 2.5 and 2.7), GMP analytical documents, SOPs, grants, CMC IND modules, peer-reviewed journal articles, and more. Other skills I have to offer are generative AI for medical writing, social media, strategic initiatives, people management, and change management.

I am actively involved with the American Medical Writers Association (AMWA), including serving in multiple roles for the Carolinas Chapter, presenting at the national conference, presenting at chapter conferences and events, and writing for the AMWA Journal.

Please visit the Blog or my LinkedIn page to get to know me better, then connect with me through the Contact form or LinkedIn.