Mirampalli Sravani

Global Clinical Publishing Associate @Novartis India

IN

In collaboration with the clinical team’s compile, integrate and publish clinical documents with word processing and giving electronic navigation using document management systems in Novartis Development environment.• Performing technical quality control (electronic functionality, adherence to internal and external document standards) of published documents• Acting as the Program Publisher independently for various programs ensuring publishing is taken care for program-specific studies and submissions• Providing input and advice to project and trial teams on the “publishing readiness” requirements for document components; Collaboration with Regulatory Managers/Clinical Trails Managers/Bio Statisticians/Regulatory and Medical writers and Global Study leads• Publishing and Dispatch is taken care for reports like Clinical Study Reports (CSR), Development Safety Reports (DSUR), Periodic Safety Update Reports (PSUR), Summary Reports (SCS/SES), Risk reports (RMP) and summary of product4 characteristics (SmPC) and Addendum statement (AS)• eCTD Gateway Dispatch activities handling for INDs Annual Reports, PSURs for EU, CP, National & MRP procedures.• Publish clinical documents (considering complexity and size) in accordance with department standards and organization KPIs. • Ensure published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and no rework once finalized. • Timeliness of deliverables meet both individual document and overall project timelines.

St. Pauls College of Pharmacy

Master of Pharmacy, Pharmaceutical Analysis

St. Mary's College of Pharmacy

Bachelor's in Pharmacy