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