Senior Medical Writer
Location: Remote
Company: ICON plc
Role Overview
ICON is looking for a Senior Medical Writer to join the world’s largest and most comprehensive clinical research organization, supporting a Top-5 pharmaceutical company. This is an exciting opportunity to contribute to the delivery of high-quality regulatory and submission documents, embedded with the client while being employed by ICON.
Key Responsibilities
Clinical & Regulatory Document Production:
Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers, including Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs), across Phase 1 to Phase 3 therapeutic areas.
Analyze and interpret data to develop clear, scientifically sound documents, applying lean writing strategies.
Serve as the primary contact for the study team regarding preparation, timelines, and planning of assigned documents.
Facilitate the review process to ensure documents are submission-ready and meet regulatory standards, collaborating with QC personnel and publishing specialists during document preparation.
Qualifications & Experience
Education:
Minimum of a bachelor’s degree (Master’s degree preferred).
Experience:
3-5 years of experience in medical writing or other relevant pharmaceutical experience, with a solid understanding of scientific and regulatory knowledge.
Strong writing skills with the ability to clearly translate scientific data into structured, well-organized messages.
Experience in writing and coordinating clinical and regulatory documents, particularly CSRs and Protocols, ensuring they are finalized and ready for submission.
Skills:
Proficiency in writing clinical documents independently.
Strong communication and collaboration skills, particularly in coordinating authoring functions and ensuring timely reviews and approvals.
Ability to work effectively with QC personnel and publishing specialists.
Benefits
ICON offers a competitive salary and benefits package, supporting your career growth and well-being.
Flexible work options, including remote work, to promote work-life balance.
Why ICON?
ICON is a leading provider of healthcare intelligence and clinical research services. With a focus on professional development, we offer employees opportunities for continued learning and career advancement in a supportive and inclusive environment.
Interested? Apply today to become part of a world-class organization dedicated to advancing healthcare and regulatory excellence.
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