Lead - Regulatory Writing

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 submission,...