Medical Writing Publisher
Location: Bangalore, India
Department: Data Management and Data Science / Medical Writing
Job ID: 26450
Employment Type: Full-Time
Experience Required: Minimum 2–3 years of experience in medical writing publishing or clinical documentation
Job Overview
The Medical Writing Publisher is responsible for supporting clinical and regulatory documentation processes, including appendices collation, peer review, quality control, and document publishing for designated projects. The role ensures compliance with organizational or sponsor Standard Operating Procedures (SOPs), ICH Good Clinical Practice (GCP), and global regulatory standards. This position plays a critical role in maintaining documentation quality, accuracy, and timely delivery of clinical research outputs.
Key Responsibilities
Clinical Documentation Support
Assist in the preparation of study-related documents including Study Protocols, Clinical Study Reports (CSRs), and Patient Narratives.
Prepare Clinical Study Report appendices in accordance with ICH E3 Section 16 requirements.
Support document publishing activities within the Medical Writing department and across related functions.
Quality Control and Compliance
Assist with peer review and quality control processes for medical and clinical documents.
Ensure all documentation complies with regulatory guidelines, internal procedures, and sponsor requirements.
Maintain document accuracy, consistency, and formatting standards across deliverables.
Project Coordination and Timeline Management
Monitor project timelines and communicate progress updates to Medical Writers, Project Managers, and clients.
Set priorities for preparatory tasks under guidance from line management and senior team members.
Ensure timely completion of assigned deliverables while maintaining quality standards.
Operational Support
Support publishing workflows and documentation processes within clinical research projects.
Collaborate with cross-functional teams to ensure efficient document management and submission readiness.
Perform additional duties related to medical writing and publishing operations as assigned.
Education Requirements
Bachelor’s degree in Biomedical Sciences, Life Sciences, or a related discipline.
Equivalent relevant experience may be considered in lieu of formal educational qualifications.
Experience Requirements
Minimum 2–3 years of professional experience in medical writing publishing, clinical documentation, or a related function.
Prior experience as a Publisher within a Medical Writing or clinical research department for national or multinational studies is required.
Understanding of clinical research processes, regulatory documentation, and publishing standards.
Required Skills and Competencies
Strong knowledge of clinical study documentation and regulatory compliance standards.
Excellent command of written and spoken English.
Strong attention to detail and document quality assurance skills.
Ability to manage multiple tasks and meet project deadlines.
Proficiency in computer applications and document management tools.
Work Environment and Physical Requirements
Work may be conducted in a home-based or office environment.
Ability to use computer systems and keyboards for extended periods (6–8 hours).
Ability to perform tasks requiring visual accuracy, including color distinction and document review.
Regular sitting and computer-based work required.
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