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Recruise India Consulting logo
Regulatory Medical/ Scientific Writer Recruise India Consulting

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 4 months ago

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