About the Role
Senior Medical Writer
Join ICON plc, a world-leading healthcare intelligence and clinical research organization. As a Senior Medical Writer, you will contribute to the advancement of clinical research, providing outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations.
At ICON, our patients are at the center of all that we do, helping accelerate the development of life-saving drugs and medical devices. Our people are the key to our success, driven by passion and mission to deliver excellent results.
What You Will Be Doing
Clinical and Regulatory Documents: Write and edit clinical and regulatory documents by applying expertise in clinical drug development. The documents you will work on include study reports, protocols, investigator brochures, summary documents, and other scientific writing.
Document Preparation: Manage document preparation, review primary statistical output, and distribute drafts for review, incorporating feedback to ensure submission-ready documents.
Project Leadership: Act as the lead medical writer for complex programs, contributing to clinical protocol development, especially for first-in-human oncology studies.
Consultancy and Guidance: Provide scientific and medical writing consultancy to project teams and offer advice when needed.
Technical Expertise: Demonstrate proficiency with medical writing templates and software such as PleaseReview and Documentum-based platforms.
What You Need to Have
Experience:
At least 3 years of experience in a medical writing role within the pharmaceutical or CRO industry. Oncology experience is preferred.
Strong regulatory writing skills and experience drafting clinical study reports, protocols, and other submission-related documents.
Education: Advanced degree in a relevant scientific, clinical, or regulatory field is preferred.
Skills:
Ability to understand and interpret clinical and scientific data and present results in a clear and concise manner for a variety of audiences.
Knowledge of current regulatory requirements and submission guidelines.
Excellent written and oral communication skills.
Proficiency in MS Word, Excel, PowerPoint, and Outlook.
Strong organizational skills with the ability to manage multiple projects and deadlines.
Why ICON?
This role offers the opportunity to work remotely from Europe, while being part of a global organization at the forefront of clinical research. At ICON, we value our people, offering a collaborative and supportive work culture with plenty of growth opportunities.
Apply Now
If you have a passion for medical writing and are looking to make an impact in the pharmaceutical industry, this is the perfect opportunity. Apply now to join ICON plc and contribute to innovative projects that improve global health outcomes.
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Mexico |northeastern :
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