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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
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,
