Job Title: Lead – Regulatory Writing
Date Posted: 7 August 2025
Location: Bangalore, Karnataka, India
Employment Type: Full-time
About the Company:
Indegene is a technology-led healthcare solutions provider enabling healthcare organizations to be future-ready. We operate at the intersection of healthcare and technology, offering global growth opportunities for bold, industrious, and nimble talent. Our culture celebrates entrepreneurship, collaboration, and innovation.
Role Purpose:
The Lead Medical Writer will lead the preparation, review, and delivery of high-quality clinical and regulatory documents for global submissions, mentor junior writers, ensure adherence to lean authoring principles, and maintain compliance with regulatory requirements and company best practices.
Education Requirements:
MBBS, PhD, MDS, BDS, MPharm, or PharmD.
Experience Requirements:
5–10 years in authoring clinical and regulatory documents for global filings (CTD Module 2, 4, and 5).
Proven experience with Modules 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, and Investigator Brochures (IBs).
Key Skills & Competencies:
Scientific & Regulatory Knowledge:
Strong understanding of global regulatory guidelines (EU, US, ICH).
Ability to interpret data, build regulatory arguments, and maintain consistent messaging across documents.
Knowledge of clinical development, trial design, and medical practices.
Technical Skills:
Expert in MS Word, including advanced formatting and styles.
Proficient in document management systems and electronic approvals.
Experience with Word add-ins and structured content libraries.
Leadership & Project Management:
Ability to lead cross-functional teams, develop work plans, and manage timelines.
Skilled in facilitating review meetings, negotiating feedback, and ensuring document quality.
Comfortable working across multiple therapeutic areas.
Core Responsibilities:
Author and review clinical and regulatory documents independently (CSRs, protocols, IBs, summaries).
Apply lean authoring principles and structured content management.
Plan and coordinate review cycles, consensus meetings, and quality control checks.
Lead document kick-off meetings and maintain open communication across teams.
Mentor junior writers and support departmental initiatives.
Conduct literature searches and stay updated on evolving regulatory requirements.
Share lessons learned and implement best practices.
Work Location Assignment: On Premise / Hybrid (per company policy)
Estimated Salary: ₹22–30 LPA (based on market benchmarks for senior medical writing leadership in India)
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