I have professional experience that would be immediately beneficial to any medical writing team. As a medical writer, I’ve been the lead author for 14 protocols (Phase 1-3), 9 clinical study reports (CSRs), 5 Investigator’s Brochure updates, 1 investigational medicinal product dossier, and multiple patient narratives. I’m familiar with AME, PK, DDI, SAD/MAD, FIH, and efficacy studies of varying complexity that span a variety of therapeutic areas, including oncology, immunooncology, cardiovascular, respiratory, and neuroscience. Additionally, I’ve developed a corporate style guide and corporate templates for protocols, IBs, and ICFs.
I consistently author high-quality regulatory documents in accordance relevant SOPs and ICH guidelines, address client comments and internal review comments during the document lifecycle, provide value-added suggestions, and maintain communication and leadership within projects, resulting in a quicker time from drafting to finalization. I am also proficient with software and document management platforms including the MS Office Suite, Visio, Adobe, Veeva, Sharepoint, and PleaseReview.
I learned at a young age that you can’t be successful as a one trick pony so as a medical writer, I can use my ability to interpret technical data and to write clinical study reports, protocols, and other regulatory documents. I revel in the revision process and how each round of editing leads to increased clarity and conciseness. I relish the opportunity to receive constructive criticism and feedback from those who excel in the field, and I enjoy how the integration of feedback from experienced writers can elevate my writing.
In the future, I’m looking to make a long-term commitment with a company where my hard work is recognized with advanced responsibility.