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2.0 - 6.0 years
5 - 7 Lacs
ahmedabad, gujarat, india
On-site
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
Posted 1 week ago
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