Medical Writer – Sponsor Dedicated

This is a fully remote position, open to applicants in Italy.

📋 Description

• Assist in the setup and ongoing management of clinical documents within the Electronic Document Management System (EDMS).

• Evaluate document status and help manage document workflow activities in sponsor systems.

• Oversee document timelines and aid project teams by monitoring essential deliverables.

• Create meeting materials and participate in trial team and submission meetings, recording actions and outcomes as necessary.

• Facilitate the organization and documentation of kick-off meetings and Results Alignment Meetings.

• Write sections of clinical documents and assist in preparing tables, figures, and supplementary content.

• Manage document review processes and aid in gathering and integrating stakeholder feedback.

• Support Quality Control tasks and ensure the completion of necessary documentation.

• Aid in the preparation of final document packages for review, publication, and archiving processes.

• Perform technical and formatting checks for Investigator Brochures and associated clinical documents.

• Keep accurate records and documentation in line with sponsor protocols and SOPs.

⛳️ Requirements

• A scientific degree and/or an advanced scientific degree.

• 1-3 years of experience in medical writing.

• Familiarity with ICH-GCP, regulatory standards, and clinical trial workflows.

• Experience with document management systems and clinical development documentation.

🏝️ Benefits

• Health insurance

• Professional development opportunities