This is a full time role based in Pune. The person will oversee medical monitoring and allied activities for clinical trials (Phase 1-4) and also support clinical development strategy function.
- Review study documents (Protocol, IB, ICD, SAP, , medical coding reports, CSR, etc.)
- Review mock and final TFLs, AE/SAE data, clinical study reports
- Prepare regulatory briefing documents, submission dossiers, etc.
- Respond to site/EC/regulatory queries
- Assessment of protocol deviations, assessment of ongoing safely and efficacy data, evaluation of SAEs, training of the operations team on therapy area and protocol etc.
- Literature search for products under evaluation for deciding strategies
- Support medical writing, data management and biostatistics teams
- Evaluate 505(b)(2) applications, create clinical development strategy and plans for FDA, EMA, PMDA etc.
