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- Tasks: Write and coordinate clinical trial documents for innovative pharmaceutical projects.
- Company: Join ICON, a leader in bringing life-improving drugs to market with a culture of innovation.
- Benefits: Enjoy remote work flexibility and the chance to impact global health.
- Why this job: Be part of a dynamic team dedicated to improving lives through groundbreaking research.
- Qualifications: Bachelor’s Degree and 2-3 years of experience in regulatory writing required.
- Other info: This role is exclusively for candidates based in Ireland.
The predicted salary is between 36000 - 60000 £ per year.
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:- Study protocols and protocol amendments
- Initial Investigator's Brochure (IB) and IB updates
- Clinical study reports
- 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.
- 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
Contact Detail:
ICON Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer - Ireland home based
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements and guidelines for clinical trial documents in Ireland. Understanding the nuances of local regulations will not only enhance your writing but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience in medical writing. Engaging with others in the field can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Showcase your project management skills by discussing any relevant experiences where you successfully coordinated multiple tasks or projects. This will highlight your ability to manage timelines and collaborate effectively, which is crucial for this role.
✨Tip Number 4
Prepare to discuss your experience with different types of clinical trial documents during interviews. Being able to articulate your familiarity with study protocols, investigator's brochures, and clinical study reports will set you apart from other candidates.
We think you need these skills to ace Senior Medical Writer - Ireland home based
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the specific responsibilities and requirements of the Senior Medical Writer position. Tailor your application to highlight relevant experience in writing clinical trial documents.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 2-3 years of experience in writing regulatory or clinical trial documents. Provide examples of study protocols, amendments, or Investigator's Brochures you have worked on.
Showcase Language Proficiency: Demonstrate your mastery of written and verbal English in your application. Use clear, concise language and avoid jargon unless necessary. This is crucial for a role that involves creating regulatory documents.
Tailor Your Application: Customise your CV and cover letter to reflect the culture of innovation and flexibility mentioned in the job description. Show how your skills and experiences align with the company's vision of bringing life-improving drugs to market.
How to prepare for a job interview at ICON
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing ability is crucial. Bring samples of your previous work, especially clinical trial documents, to demonstrate your expertise and style. Be prepared to discuss your writing process and how you ensure accuracy and clarity in your documents.
✨Understand the Regulatory Landscape
Familiarise yourself with the regulatory requirements for clinical trial documents. During the interview, be ready to discuss your knowledge of guidelines such as ICH-GCP and how they influence your writing. This shows that you are not only a skilled writer but also understand the context of your work.
✨Highlight Project Management Experience
Since the role involves coordinating document development, emphasise your project management skills. Share examples of how you've managed timelines, collaborated with teams, and handled feedback from multiple stakeholders to deliver high-quality documents on time.
✨Cultural Awareness and Flexibility
Given the global nature of the client, demonstrate your ability to work across cultures and time zones. Discuss any previous experiences where you successfully collaborated with international teams, showcasing your adaptability and communication skills.
