Job Title: Lead – Regulatory Writing
Date Posted: 5 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 offer global, accelerated career opportunities at the intersection of healthcare and technology, guided by passion, innovation, collaboration, and empathy.
Role Purpose:
The Lead Medical Writer will oversee the development and review of medical writing deliverables supporting global clinical and regulatory submissions. The role includes mentoring junior writers, ensuring adherence to regulatory guidelines, and leading cross-functional teams to deliver high-quality, lean-authored documents within strict timelines.
Education Requirements:
MBBS, PhD, MDS, BDS, MPharm, or PharmD.
Experience Requirements:
5 to 10 years of experience in clinical and regulatory writing for global filings (CTD Module 2, 4, and 5).
Proven experience authoring regulatory documents such as Modules 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, and Investigator Brochures (IBs).
Key Skills & Competencies:
Must-Have:
Strong knowledge of global regulatory guidelines (EU, US) and industry best practices.
Ability to interpret clinical data and apply scientific knowledge to support regulatory arguments.
Expertise in lean authoring and structured content management.
Experience leading cross-functional document teams and managing timelines.
Strong MS Word skills and experience with document management systems.
Excellent communication, organizational, and stakeholder management skills.
Good-to-Have:
Experience coaching junior medical writers.
Familiarity with structured text libraries and content reusability.
Exposure to multiple therapeutic areas.
Core Responsibilities:
Prepare, review, and finalize regulatory documents (CSRs, protocols, IBs, submission summaries).
Lead document development from kickoff to final approval, ensuring compliance with lean authoring principles.
Develop and manage work plans, timelines, and team responsibilities.
Facilitate review meetings and address stakeholder feedback.
Maintain consistency in messaging across documents and projects.
Conduct literature searches and keep updated on regulatory requirements.
Share best practices and mentor junior team members.
Participate in departmental initiatives and training programs.
Work Location Assignment: On Premise / Hybrid (as per company policy)
Estimated Salary: ₹22–30 LPA (Based on market benchmarks for senior medical writing leadership roles in India)
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