Overview
As a Senior Medical Writer, you will be dedicated to one of our global pharmaceutical clients; a client with which ICON shares a culture of innovation, flexibility, and a common vision of bringing life-improving drugs to market.
Please note, this role is open for Ireland location only.
Responsibilities
The role involves working on clinical trial documents for Phase 1 and Phase 2 studies.
Writing scope:
* Study protocols and protocol amendments
* Initial Investigator's Brochure (IB) and IB updates
* Clinical study reports
Responsibilities:
* Plan, write, review, and coordinate the development of regulatory clinical trial documents.
* Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of documents as required based on internal/external input, and prepare final versions.
* Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in the appropriate document management system.
Qualifications
Key experience and requirements:
* Bachelor’s Degree
* 2-3 years of prior experience writing regulatory or clinical trial documents - Protocols/Protocol amendments/IBs
* Demonstrated mastery of written and verbal English
* Demonstrated project management and time management skills
* High-level end-user computer skills (e.g., word processing, tables, and graphics)
* Ability to work well across cultures and time zones
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