DUTIES & RESPONSIBILITIES The Pre-Clinical Senior Medical Writer serves as the clinical and scientific subject matter expert (SME) supporting the development of pre-clinical research publications. This role provides strategic scientific oversight and quality review of manuscripts authored by
This role is responsible for authoring, editing, and coordinating scientific manuscript and related publications based on pre-clinical research involving medical devices. This role transforms complex scientific, engineering, and biological data into scientific manuscripts which may include peer-reviewed publications,
Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings,