Hardhageri Sindhusha

Scientific Writer 1 @百时美施贵宝

Hyderabad, IN

Leads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets. Coordinate and author regulatory documents [eg, Investigator\'s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), and protocols] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.