Medical Writing Publisher – Clinical Study Reports & Regulatory Publishing
Location: Bangalore, India
Category: Data Management & Data Science
Employment Type: Full-Time
Experience Required: 2–3 years in Medical Writing Publishing or Clinical Document Management
ThePharmaDaily.com is featuring an opportunity for a Medical Writing Publisher to support global clinical development programs within a regulated environment. This role is ideal for professionals with hands-on experience in clinical study report (CSR) publishing, ICH E3 appendices preparation, quality control (QC), and regulatory document compliance.
This position plays a critical role in ensuring high-quality medical writing deliverables aligned with ICH-GCP guidelines, regulatory standards, and sponsor SOPs across national and multinational clinical studies.
As a Medical Writing Publisher, you will support the preparation, review, quality control, and publishing of clinical documents for global trials. You will collaborate with Medical Writers, Project Managers, and cross-functional teams to ensure accuracy, consistency, and regulatory compliance of all deliverables.
Assist in the preparation of clinical documents including:
Study Protocols
Clinical Study Reports (CSRs)
Patient Narratives
Compile and format ICH E3 Section 16 CSR Appendices
Perform peer review and quality control (QC) of medical writing deliverables
Support document publishing activities within the Medical Writing Department and cross-functional teams
Track project timelines and proactively communicate status updates to stakeholders
Ensure all documentation complies with:
ICH-GCP guidelines
Regulatory requirements
Sponsor and organizational SOPs
Coordinate preparatory tasks and maintain deadlines under guidance from senior team members
Support regulatory submission-ready documentation processes
Bachelor’s degree in Biomedical Sciences, Life Sciences, Pharmacy, Biotechnology, or a related discipline
Equivalent relevant experience may be considered in lieu of formal education
Minimum 2–3 years of experience in Medical Writing publishing, regulatory document publishing, or clinical documentation support
Prior experience as a Publisher within a Medical Writing or Clinical Development department
Experience supporting national and multinational clinical trials
Familiarity with CSR structure, appendices collation, and regulatory documentation standards
Strong understanding of:
ICH E3 guidelines
ICH-GCP requirements
Clinical trial documentation standards
Experience with document formatting, QC review, and publishing workflows
Excellent command of written and spoken English
Strong organizational skills with the ability to manage multiple timelines
Proficiency in Microsoft Office tools
High attention to detail and regulatory compliance standards
Home-based or office-based (as applicable)
Regular computer-based work (6–8 hours per day)
Ability to review detailed clinical documentation with accuracy
Medical Writing Publishers play a crucial role in ensuring that clinical study documentation is accurate, compliant, and submission-ready. This function directly supports regulatory approvals, patient safety reporting, and global clinical development milestones.
Professionals seeking careers in clinical documentation, regulatory publishing, medical writing operations, or clinical trial support will find this role aligned with long-term growth in the pharmaceutical and CRO industry.
For more global pharmaceutical, biotech, regulatory affairs, clinical research, pharmacovigilance, and data management jobs, visit ThePharmaDaily.com.
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