Act as a Lead Medical Writer on writing projects (e.g. clinical study reports, protocols). Prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Identify project needs, tracks project timelines, and implement client requests.Participate in both internal and external project team meetings and liaise directly with the customer on medical writing issues, as appropriate and with senior support as needed.Arrange appropriate internal review of assigned documents and take responsibility for on-time delivery.Perform QC review of documents or parts of documents prepared by the MSW team.Take responsibility for managing day-to-day workload for assigned tasks and projects.Well familiar with using Endnote and PerfectIT.

Medical Writing:Act as a Lead Medical Writer on writing projects (e.g. clinical study reports, protocols). Prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Identify project needs, tracks project timelines and implement client requests.Participate in both internal and external project team meetings and liaise directly with the customer on medical writing issues, as appropriate and with senior support as needed.Arrange appropriate internal review of assigned documents and take responsibility for on-time delivery.Perform QC review of documents or parts of documents prepared by the MSW team.Take responsibility for managing day-to-day workload for assigned tasks and projects.Well familiar with using Endnote and PerfectIT.Data anonymization:Develop familiarity with the Privacy Analytics de-identification methodology.Anonymize submission clinical study documents and associated study data using latest tools.Core responsibilities here include: Pre-processing documents, analyzing lengthy, technical / medical documents (Clinical Study Reports, Protocols, Statistical Analysis Plans, Safety and Efficacy Reports, Case Report Forms), checking the quality of automated document processing steps and manually securing patient and commercial information.

Developing and writing Clinical trial protocols and presenting the trial protocols to the Steering committee.Designing Case Report forms and other trial related documentation.Liasoning with consultants or investigators on conducting the trial.Conduct Source data verification by verifying the data entered on the CRF is consistent with patient notes .Archiving study documentation and correspondence.Preparing final reports and manuscripts for publications.Monitoring data for safety and efficacy trends by reviewing clinical data.Extracting and compiling research data.Complied and prepared manuscripts (original articles, case reports/series, photo essays) for various reputed journals like OSLI, IJO, EJO, Retina.Compiled data and prepared the RETINA ATLAS (ISBN 9789389587432)

•Adhere to project-specific data tracking guidelines and relevant Standard Operating Procedures(SOPs)/Work Instructions (WIs).• Receive applicable project documents, e.g., Trial Master File Documentation, Investigator FileDocumentation, Case Report Forms (CRFs), Data Clarification Forms (DCFs), and/or DataManagement Files.• Process, scan, index, route, and maintain files for CRFs, DCFs and data management documentsin accordance with SOPs/WIs.• Check the quality of documents and index them in suitable index of eTMF.• Sending queries in case of any discrepancy/issues with the documents and to resolve themtimely.• Maintain the security and compliance of all documents related to ongoing projects and archiveddocuments in accordance with relevant SOPs/WIs.• Respond timely to requests for site documents, pulling and re-filing site documents; ensureapplicable paperwork is completed upon release from and returned to the Document ControlRoom.• Participate in preparation/reconciliation of site documentation related to archival/shipping tosponsors.• Participate in project specific training as required.• Well trained in working with Trial Interactive and Veeva Vault Platforms for eTMF maintenance.