Medical Writer I
ICON is a general 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; environment. 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 manage workflows and approve documents.
Serv
📌 Medical Writer I (Barcelona)
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📍 Barcelona
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