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