Medical Writer - Bioequivalence Studies (Gandhinagar)

Medical Writer - Bioequivalence Studies (Gandhinagar)

29 Aug
|
Torrent Pharmaceuticals
|
Gandhinagar

29 Aug

Torrent Pharmaceuticals

Gandhinagar

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 - Bioequivalence Studies (Gandhinagar)
🏢 Torrent Pharmaceuticals
📍 Gandhinagar

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