Job description
Role & responsibilities
. Feasibility assessment/ current product evaluation
• Literature review and BA/BE study designing
• BE Study Monitoring
• Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.)
• Establishment and maintenance of study documents
• Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.)
• Review of BE study documents i.e protocol, reports, ICF etc.
• Preparation/review of medical write up
• Coordination for serious adverse event reporting and safety update to Regulatory agency
📌 Medical Writer (Gandhinagar)
🏢 Torrent Pharmaceuticals
📍 Gandhinagar
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