Senior Medical Writer
2 weeks ago
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.
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.
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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