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.
We are also reviewing freelance regulatory medical writers based in Ireland.
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:
1. Study protocols and protocol amendments
2. Initial Investigator's Brochure (IB) and IB updates
3. Clinical study reports
Responsibilities:
1. Plan, write, review, and coordinate the development of regulatory clinical trial documents.
2. 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.
3. Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in the appropriate document management system.
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Key experience and requirements:
1. Bachelor’s Degree
2. 2-3 years of prior experience writing regulatory or clinical trial documents - Protocols/Protocol amendments/IBs
3. Demonstrated mastery of written and verbal English
4. Demonstrated project management and time management skills
5. High-level end-user computer skills (e.g., word processing, tables, and graphics)
6. Ability to work well across cultures and time zones
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