Venugopal V Durvasula

Senior Manager Project Management @Hikma Pharmaceuticals

Columbus, OH, US

Led cross-functional project teams from initiation to post-filing, coordinating with PD, RA, Clinical, IP, Finance, and Manufacturing functions.* Initiated and managed project infrastructure including PR, ION, NDC, and NC number requests; established shared folders to streamline team collaboration.* Planned and facilitated Kick-off, Pre-PSC, PSC, and TSG meetings (TSG3 – Pre-registration, TSG5 – Pre-filing, TSG6 – Postfiling/ Launch); tracked risks, timelines, and action items.* Created and maintained detailed project budget files; worked closely with the Finance team for expense reconciliation, quarterly re-forecasting, and monthly reporting.* Oversaw procurement and PO creation for API, RLD, excipients, components, and tooling; ensured vendor setup and timely material availability.* Collaborated with medical and clinical teams to align on regulatory and clinical trial requirements, including NDA/ANDA dosing schedules and timelines.* Supported post-submission technology transfer processes in partnership with TS PMs; managed risk register handoff and launch preparation tasks.* Drafted and routed discontinuation memos; ensured timely communication and documentation flow among stakeholders.* Used MS Project (PWA), Excel, SharePoint, and OneNote to track project deliverables, maintain documentation, and support real time collaboration.* Conducted regular alignment meetings with Procurement, QC, and Manufacturing to monitor status, mitigate risks, and support batch readiness.

GITAM Deemed University

Doctor of Philosophy - PhD