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
Documentation, Desiging
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Research Executive • Ahmedabad, Gandhinagar
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