Job Title: Lead – Regulatory Writing
Date Posted: 18 July 2025
Location: Bangalore, Karnataka, India
Employment Type: Full-time
About the Company:
A global leader in clinical research and regulatory documentation, committed to delivering high-quality, compliant, and scientifically robust submissions to health authorities worldwide.
Role Purpose:
The Lead Medical Writer is responsible for the independent development, review, and delivery of medical and regulatory writing outputs that support global filings (CTD Module 2 and Module 5). The role also involves mentoring junior writers, ensuring lean authoring, and driving cross-functional collaboration for timely, high-quality document delivery.
Education Requirements:
MBBS, PhD, MDS, BDS, MPharm, or PharmD
Experience Requirements:
4–6 years of experience in authoring clinical and regulatory documents for global submissions.
Preferably experienced with CTD Modules 2.3, 2.4, 2.5, 2.7, 5.2, CSRs, protocols, amendments, ICFs, and IBs.
Key Skills & Competencies:
Strong scientific writing and editing skills following defined templates and processes.
Expertise in cross-functional team leadership for document drafting and content alignment.
Understanding of clinical trial design, development processes, and submission strategy.
Excellent time management, organizational, and interpersonal skills.
Strong customer focus with the ability to work independently while maintaining clear communication.
Ability to manage multiple documents, roles, timelines, and review cycles effectively.
Proficiency in facilitating review meetings and negotiating solutions for content alignment.
Knowledge Requirements:
Scientific Knowledge
Strong grasp of ICH guidelines, FDA, and EMA requirements.
Ability to interpret clinical data, apply therapeutic area knowledge, and build scientific arguments.
Knowledge of medical practices, treatment modalities, and procedures.
Capability to maintain content consistency and align with regulatory strategy.
Technology Skills
Advanced MS Word skills, including style management and document formatting.
Experience in document management systems (e.g., eApproval/signature workflows).
Familiarity with Word add-ins for reference and style management.
Flexibility to adopt new authoring tools and technologies.
Core Responsibilities:
Independently prepare/review CSRs, protocols, IBs, submission data summaries, and other regulatory documents.
Apply lean authoring principles and structured content libraries for efficiency.
Plan and lead document review cycles, consensus meetings, QC checks, and finalization within timelines.
Act as Medical Writing representative in cross-functional teams, ensuring open communication.
Lead document kick-off meetings and coordinate content development with stakeholders.
Maintain project timelines and ensure adherence to messaging and content standards.
Mentor junior writers and share best practices.
Conduct literature searches and remain updated on evolving regulatory requirements.
Participate in departmental initiatives to enhance writing processes and tools.
Work Location Assignment: On Premise / Hybrid (based on organizational policy)
Estimated Salary: ₹25–32 LPA (Based on senior regulatory writing roles in multinational pharma/clinical research organizations in India)
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