As a Principal Medical Writer, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
You will support a Top-5 biotech company, helping deliver top-tier regulatory and submission documents. While employed by ICON, you will be fully embedded with our client, contributing your medical writing expertise to reduce time to market for their deep antibody pipeline.
The position is home-office based, focusing on autoimmune diseases. Working for our client, you will benefit from ICON's continuous learning opportunities and long-term career development.
What you will be doing: Medical Writing Excellence
* Deliver clinical, regulatory, and submission documents.
* Draft and manage well-organized, accurate, consistent, and clear documents tailored to the target audience.
* Develop key documents such as clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules, and other clinical/regulatory documents.
* Lead and advise clinical teams on content and process improvements.
* Ensure compliance with company SOPs and regulations.
* Coordinate in a multi-stakeholder environment for seamless regulatory document delivery.
* Collaborate with clinical program leadership to meet project deadlines.
Functional Leadership
* Guide clinical teams on medical writing best practices.
* Promote documentation consistency using templates and style guides.
* Disseminate industry and health authority guidelines.
* Represent medical writing in internal meetings.
* Propose process improvements for high-quality document delivery.
* Potentially participate in industry standards working groups.
* Represent the medical writing team during audits, ensuring timely responses.
You are :
* Minimum 6 years of pharmaceutical/biotech medical writing experience.
* Master's degree in a relevant scientific or medical field; PhD preferred.
* Knowledge of FDA and ICH guidelines for clinical reporting.
* Experience with eCTD development and submission is preferred.
* Understanding of drug development phases and processes.
* Excellent communication skills and collaborative mindset.
* Proactive with process improvement ideas.
* Skilled in proofreading for compliance.
* Experience in electronic publishing is a plus.
We offer a comprehensive, competitive total rewards package, including base pay, variable incentives, recognition programs, and top-tier employee benefits supporting you and your family throughout your career with ICON.
You will be a key medical writer at a leading biotech company while being a full ICON employee.
ICON is an equal opportunity and inclusive employer.
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