Dr. Fiona Dunlevy PhD
Skills And Services Offered:
I am an experienced medical writer available for regulatory documents and medcomms projects. My medical writing experience spans the drug development process from clinical trials to registration, and beyond. I'm also a popular science writer with 30 published articles about EU-funded research, science policy and medtech.
My text is accurate, clear, engaging and tailored to your audience to get the right message to the right people.
- Protocol and ICF
- CSR (including lay summary)
- Medical devices CIP and CER
- Phase IV and NIS protocols and reports
- Briefing books for FDA/ EMA
- CTD, ISE/ISS
- Response to questions
- Request for priority review
- Manuscripts and posters
- Advisory board reports
- Conference reports
- Press releases
- Internal communications materials
- Website content
- News articles
Fiona has experience in a wide range of therapeutic areas, including oncology, respiratory, immunology, dermatology, gynacology, medical devices and opthamology, amongst others.
I left Ireland and academia in 2010 and moved to the south of France, where I gained diverse experience in regulatory writing and medcomms in Scinopsis, a medical writing agency.
Now a freelance writer, I can support your documents throughout the drug development process, from bench to bedside to market. My documents are accurate, concise, clear and on time. I understand how to get the best out of the authoring team, reducing time delays by effectively resolving queries as they crop up.
Having successfully completed projects for various pharma and biotech companies, I can quickly adapt to your product, indication, internal SOPs and practices, while staying true to international guidelines.
I have a BSc in Biochemistry and a PhD studying airway inflammation in Cystic Fibrosis. To feed my general enthusiam for science and medicine, I write popular science articles for lay readers about medtech, biomedical research and science policy. I speak English and French and am happy to travel to visit my clients or attend conferences.
While not medical writing or popular science writing, you can find me on the water sailing or kitesurfing, or up a mountain hiking.
I look forward to hearing from you about how I can support your project.
Some feedback from my clients:
"Many thanks for this wonderful shell CSR!"
"We’ve had quite a few CSRs to review and your CSR was very well written."
"I have reviewed the draft and found it already very good."