Medical Writer - Bioequivalence Studies

Job description

Role & responsibilities

• . Feasibility assessment / new 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 Required

Risk Management, Reporting, Testing