Medical Writer - Bioequivalence Studies (Gandhinagar)

Medical Writer - Bioequivalence Studies (Gandhinagar)

28 Aug
|
Torrent Pharmaceuticals
|
Gandhinagar

28 Aug

Torrent Pharmaceuticals

Gandhinagar

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

Skills: Testing, Reporting, Risk Management

Experience: 1.00-6.00 Years

📌 Medical Writer - Bioequivalence Studies (Gandhinagar)
🏢 Torrent Pharmaceuticals
📍 Gandhinagar

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