About the Role
Principal Medical Writer
Join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. As a Principal Medical Writer, you will be supporting a Top-5 biotech company, helping them deliver best-in-class regulatory and submission documents. You’ll be employed by ICON while being fully embedded with the client, contributing to the success of their autoimmune disease pipeline. This position offers the flexibility of home-office work and the opportunity for continued professional development and career growth at ICON.
What You Will Be Doing
Medical Writing Excellence
Deliver all types of clinical, regulatory, and submission documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules, and more.
Ensure documents are well-organized, accurate, consistent, unambiguous, and tailored for the target audience.
Take a lead role in advising and guiding clinical teams on content and processes, ensuring alignment with company SOPs and regulations.
Lead multi-stakeholder teams to ensure timely and seamless delivery of high-quality regulatory documents.
Interact closely with clinical program leadership to establish and safeguard project deadlines.
Functional Leadership
Proactively guide clinical teams on best-in-class medical writing processes and documentation standards.
Ensure consistency in documentation across programs, using templates and company style guides.
Stay up-to-date on industry and regulatory guidelines and disseminate this knowledge to internal teams.
Represent the medical writing function at internal meetings, including project and program management status updates.
Recommend process improvements to foster high-quality regulatory document delivery.
Participate in industry standards working groups and represent the medical writing function during audits of clinical trial documents.
Your Profile
Experience: Minimum of 6 years in pharmaceutical or biotechnology-related medical writing.
Education: Master’s degree in a scientific, medical, clinical, or related field is required; PhD preferred.
Skills:
Strong knowledge of FDA and ICH guidelines for clinical reporting.
Experience with eCTD development and submissions is preferred.
Deep understanding of key drug development phases, processes, and techniques from protocol development to submission.
Excellent communication skills and ability to drive cross-functional collaboration.
Proactive mindset with a focus on continuous improvement of processes.
Strong proofreading skills to ensure compliance with internal and external guidance.
Ability to ensure consistency in documents across multiple indications.
Experience with electronic publishing is preferred.
Benefits
ICON offers a comprehensive and competitive total rewards package, including:
Competitive salary with a variety of variable pay and recognition programs.
Best-in-class employee benefits designed to support you and your family at all stages of your career.
Continued learning opportunities and career growth while being embedded with a Top-5 biotech company.
Why ICON?
At ICON, we prioritize the development of our employees through a continuous learning culture. We offer engaging work experiences, and every opportunity is designed to contribute to your professional growth. ICON is committed to providing an inclusive workplace free from discrimination or harassment. All qualified applicants will receive equal consideration for employment.
If you require reasonable accommodation during the application process or for any essential functions of the role, please let us know.
Apply Now
Not sure if you meet all the requirements? We encourage you to apply regardless. There's every chance you're exactly what we're looking for at ICON, whether for this or other roles.
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