Senior Medical Writer - Ireland home based

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 lifeimproving drugs to market.
We are also reviwing freelance regulatory medical writers based in Ireland.
Please note , this is role is open for Ireland location only.

The role and 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.
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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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