Welcome

I am a medical writer with a PhD in chemistry and over 14 years of pharmaceutical experience, including 4 years of direct medical writing experience. I have written health authority question responses, 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 graphic design in Canva, social media, website writing and management (WordPress), 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 conference reports for the AMWA Journal.

I’ve worked on the lab bench with everything from DNA, to peptides, to antibody-drug conjugates, to small molecules. I know how it is to be buried in regulatory and internal documents to write under intense time pressure. Please visit the Resume and Blog links to get to know me better, then connect with me through the Contact form or through LinkedIn. I look forward to helping you with your pharmaceutical and regulatory documentation. Please contact Whitsell Innovations to work with me or another one of our talented writers!