Dr Shishir Jain

Dr. Shishir Jain is an experienced professional in medical writing and regulatory documentation with a career spanning over a decade. Currently serving as Associate Director of Medical Writing Operations at Alexion Pharmaceuticals, Inc. since January 2023, Shishir has held various roles, including Principal Medical Writer at ICON plc and Regulatory Documentation Scientist at Roche. Throughout career, Shishir has consistently contributed to the preparation and review of regulatory submission documents, including DSUR, PBRER/PSUR, and Clinical Study Reports, while assisting with eCTD submissions to Health Authorities such as the FDA and EMA. Dr. Jain holds an MBA in Operations and Marketing, a Post Graduate Diploma in Clinical Trial Management, and a Bachelor of Dental Surgery.