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 amendmentsInitial Investigator's Brochure (IB) and IB updatesClinical study reportsResponsibilities: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 Degree2-3 years of prior experience writing regulatory or clinical trial documents - Protocols/Protocol amendments/IBsDemonstrated mastery of written and verbal EnglishDemonstrated project management and time management skillsHigh-level end-user computer skills (e.g., word processing, tables, and graphics)Ability to work well across cultures and time zones