Amit Goomber

Background

About Amit Goomber

M.Pharm with 14 years of work experience, with 12 years in medical/regulatory writing. Experience in writing, review and independently managing high quality clinical documents including complex clinical study reports (CSR), and Module 2 CTD documents in Oncology therapeutic area. The key roles in current job profile include: Supporting multiple global regulatory submissions by majorly contributing together with the clinical authors towards high level registration documents including registration CSR, Module 2 CTD documents (Clinical Overview, Summary of Clinical Efficacy, Summary of Clinical Safety), and other related lead-in or follow-up activities (e.g. type II Variations, 120-Day Update Reports). Lead Writer for submissions, contributing to key messaging, statistical analysis plan, and pooling strategy and provide content guidance for clinical portions of the CTD. To provide strategic and operational input to teams to achieve high quality, message-led, label-focused submission documents, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Coach/mentor new submission writers in the group