30 Aug
|
Torrent Pharmaceuticals
|
India
30 Aug
Torrent Pharmaceuticals
India
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 reliable adverse event reporting and safety update to Regulatory agency
📌 Medical Writer Gandhinagar (India)
🏢 Torrent Pharmaceuticals
📍 India