About the Role
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
Experience: 6-10 years in writing Clinical & Regulatory documents for global filings (CSR, CSP, CTD Module 2, and Module 5)
Role Purpose: The Lead Medical Writer will develop and review medical writing deliverables that support the clinical regulatory writing portfolio and provide training to junior writers.
Skills Required:
- Experience in authoring various clinical document types for regulatory filings, with a preference for Module 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, and Investigator Brochures (IBs)
- Excellence in focused writing and editing, adhering to defined processes and templates
- Ability to lead cross-functional teams in drafting scientific and medical content that addresses data interpretation, product claims, and internal/external inquiries
- Understanding of the clinical development process from program planning to submiss...
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