Posted:1 month ago|
Platform:
Hybrid
Full Time
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 build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science • Understanding of medical practices regarding procedures, medications, and treatment for dierent disease states • Manage messaging for consistency with historical information and in alignment with agreed-upon strategy • Capable of providing insight, alternatives, and suggestions based on previous experiences • Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring • Experience writing protocols, amendments, CSR, and CTD summary documents
Recruise India Consulting
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