Medical Writer
Biocon Biologics
Bangalore, KarnatakaScientific & QA Jobs
About the role
Job Description 1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan. 3. Collaborating across line functions in preparing SOPs for Regulatory documents. 4. Interpreting, representing and summarizing clinical and scientific data…