15+ years in Biotech/CRO having been an integral member for multiple submissions in oncology, rare diseases, neurology programs. Designing, developing and managing all integrated datasets for comprehensive overview of safety profile along with anti-tumor activities of Zanidatamab/ Lurbinectedin/ Eteplirsen studies. Expertise to support all CSR related activities and preparation of study packages (aCRF, define.xml, SDRG/ADRG, etc.) for regulatory deliverables and submission.