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Job OverviewProvide Trial Master File (TMF) related assistance to study teams. Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, ..
... completion of the deliverable in compliance with all applicable service level ... line listingsu2022 author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee ... QC review safety responses to..
Preparation of documents and facilitation of documentation management in R&D while following established guidelines for correctness, completeness and clarity.Preparation of documents such as Manufacturing Batch Records, Study Protocol and Reports, Stability ..
