Apply Online for Medical Writer at ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.

Post : Medical Writer I

Job Description
• Perform Trial Master File (TMF) Quality Control (QC) ensuring inspection readiness and compliance with ICH guidelines (E3, E6)/GxP requirements for documents prepared by medical writers (MWs)
• Maintain EndNote Libraries and literature reference to support medical writing activities
• Support full CSR lifecycle including narrative coordination, appendices management, and submission readiness
• Support for MW with formatting of draft tables and documents
• QC checks of documents against source materials
• Document/Submission Plan preparation (trackers for Publishing)
• Final formatting of documents and technical checks for submission readiness
• Manage document workflows within EDMS (e.g., Veeva Vault), including upload, version control, approvals, and compliance tracking

Serve as a technical resource
• Manage multiple projects simultaneously and be a subject matter expert in document management system processes and procedures, which include granular clinical study reports and other regulatory documents; act as a liaison with functional area teams to manage workflows and approve documents.
• Serve as a technical expert for clinical research teams regarding the regulatory EDMS and regulatory publishing requirements
• Independently plan and execute assignments

Candidate Profile
• Bachelor’s degree or 2+ years of related experience is required; scientific field preferred
• Experience in the preparation of documents for submission using Regulatory/EDMS preferred, e.g., Veeva Vault
• Strong working knowledge of Adobe Acrobat and Microsoft Word is essential
• Advanced computer proficiency required, including expert knowledge of Microsoft Word (templates, automation, styles) and adobe QC tools.
• Proficiency with AI tools, preferred
• Working knowledge of the use and maintenance of document templates
• Knowledge of requirements for electronic submissions to regulatory authorities and records management required (e.g., ICH (E3 &E6), CFR 21 Part 11)

Additional Information
Experience : 2+ years
Qualification : Bachelor’s degree
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th September 2026