Senior Medical Writer - Ireland home based

				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 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.

Responsibilities:

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.

#LI-NR1 

#LI-Remote

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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