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| Job Location | Mumbai City |
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Review of study Protocol , CRF , ICF , Subject questionnaire and its compliance with regulatory. Cross checking of IEC summary reports , Investigators brochures and clinical reports and narratives. Preparation of clinical updates and AE and SAE narratives and its reporting. Draft Narratives Perform 100% data- review and finalization of Narratives Fill the defect tracker and track errors in every medical writing project Coordinate a set of medical writing activities associated with a drug program therapy team Review and QC all deliverables Ensure that documents are approved and issued in accordance with timelines Request data sources and attend client calls for medical writing deliverables kick- off meetings , review meetings and status updates. ,
Keyskills :
adobecreativesuite medicalwriting summaryreports qc bpo crf iec set icf ites pharma medical writing therapy clinical protocol compliance milestones preparation tatementsofworksow