ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are currently seeking Medical Writer I to join our diverse and dynamic team. At this role you will be responsible for end-to-end preparation, quality control, and lifecycle management of clinical and regulatory documents within a GxP-compliant R&D; workplace. This Medical Writer assists as needed with ensuring that documents are processed within the Electronic Document Management System (EDMS). The ideal candidate will be an early-career professional with a strong interest to develop and grow into a Medical Writer role
What You Will Be Doing:
- 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 man
📌 Medical Writer I (Bengaluru)
🏢 ICON
📍 Bengaluru
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