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3.0 - 8.0 years
15 - 30 Lacs
Bengaluru
Hybrid
Experience in authoring a broad set of dierent clinical document types that support regulatory filings with a preference for experience with Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs,) protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs) • Demonstrated excellence in focused/lean writing and editing following defined processes and template Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States • Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) • Ability to ...
Posted 5 months ago
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