About the Role
Senior Medical Writer
Join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. As a Senior Medical Writer, you will be supporting a Top-5 pharma company, helping to deliver best-in-class regulatory and submission documents. This role is a 1-year fixed-term contract, with the opportunity to work in close collaboration with the client while being stably employed by ICON.
What You Will Be Doing
Document Preparation: Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. Documents may include clinical summary documents, briefing books, response documents, and Pediatric Investigation Plans (PIPs), across Phase 1 to Phase 3 in multiple therapeutic areas.
Data Interpretation: Analyze and interpret clinical data critically to determine the best approach for document composition, applying lean writing strategies.
Study Team Interaction: Serve as the primary contact for the study team in relation to the preparation and timelines of assigned documents.
Document Review: Facilitate the review process, ensuring documents are submission-ready and fully approved. You will collaborate with QC personnel and publishing specialists to support document preparation.
Your Profile
Experience:
Minimum of 3-5 years of Medical Writing experience or equivalent pharmaceutical experience with strong scientific and regulatory knowledge.
Proficient in independently writing several types of clinical/regulatory documents, particularly clinical summary documents, briefing books, and response documents.
Education: Minimum requirement of a Bachelor’s degree, with a Master’s degree preferred.
Skills:
Strong writing abilities and the capacity to convert complex scientific data into clear, scientifically accurate, and well-structured messages.
Experience in leading the creation, coordination, and review of regulatory documents to ensure they are submission-ready.
Why ICON?
Stability: While employed with ICON, you will be embedded with the client, contributing to high-impact projects within a leading global pharma company.
Growth Opportunities: Gain exposure to cutting-edge clinical research and regulatory processes, furthering your career in medical writing.
Apply Now
This role is remote, allowing you to work flexibly while contributing to meaningful projects in the pharmaceutical industry. If you’re passionate about medical writing and regulatory submissions, we encourage you to apply!
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