Senior Clinical Writer And Editor
Current• Medical writing consulting for start-up to mid-sized pharmaceutical companies.• Writing and editing a variety of documents, including, but not limited to: - CSR (full, abbreviated, and synoptic) - de novo Protocol - Protocol Amendment - Clinical IND documents (Module 2.5 and GIP) - DSUR - IB update - 120-Day Safety Update - Fast Track designation - EOP BB - Type C BB• Implementing and documenting processes around document structure, preparation, collaboration, and reviews.• Preparing and implementing document timelines through document completion, including managing SME input, review cycles, QC, and publishing submission-ready PDFs.• Analyzing clinical trial data.• Working across cross-functional teams, including, but not limited to, SMEs, QC, QA, and publishing.• MS Office, Acumen tool suite, StartingPoint, SharePoint, Please Review, Veeva, ShareFile.