Senior Medical Writer

Senior Medical Writer-United States-Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of inNvative treatments and therapies.

What you will be doing
 

• Prepare and review regulatory documents: Develop, write, edit, and review high-quality documents based on regulations and scientific data for submission to regulatory agencies and health authorities.
• Collaborate with cross-functional teams: Act as the Regulatory Scientific Writing (RSW) representative on project teams, engaging with Global Regulatory Project Teams (GRPT) and functional contributors (e.g., Clinical, Pharmacovigilance, CPPM).
• Manage projects and timelines: Participate in project management for compound programs, ensuring accurate and timely completion of regulatory submissions, while communicating deliverables, writing processes, and milestones to team members.
• Interpret and present scientific data: Assimilate and interpret diverse information sources, ensuring data is clear, complete, and compliant with regulatory requirements. Challenge conclusions when necessary to uphold quality.
• Coordinate review and quality control: Oversee the review, approval, and quality control processes for regulatory documents, facilitating team review meetings and resolving content issues.
• Maintain compliance and standards: Ensure documents adhere to appropriate conventions, grammar, format requirements, and divisional guidelines per ICH and other governing bodies.
• Support process improvements: Assist in the design and implementation of tactical process improvements and communicate resource needs to leadership as timelines progress.

Your profile

• Educational Requirements: A Bachelor’s degree is required, with a preference for degrees in Science, English, Communications, or related fields. Advanced degrees (e.g., MS, PharmD, PhD, MD) are valued and can substitute for years of experience. Certification in medical or pharmaceutical writing (e.g., AMWA) is highly regarded but not mandatory.
• Experience and Background: A minimum of 2 years of relevant experience in medical/regulatory writing, or in related fields such as quality, clinical research, product support, regulatory affairs, or academia. Diverse professional experiences are welcome.
• Writing and Communication Skills: Demonstrated ability to write high-quality, precise content for clinical development and regulatory purposes. Strong oral and written communication skills with the ability to present scientific content to varied audiences.
• Regulatory and Industry Knowledge: Familiarity with US and international regulations, guidelines, and submission requirements. Understanding of regulatory document compliance and experience working with Common Technical Document (CTD) templates and electronic systems.
• Attention to Detail: Exceptional focus on consistency, clarity, and accuracy in written materials, with the ability to identify and address inconsistencies.
• Technical Skills: Proficiency in Windows-based software and electronic document management systems, with a willingness to learn and adapt to new technologies.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.  All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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