Principal Medical Writer at ICON Remote

ICON; United States; Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Life insurance

Employee assistance program

Annual leave

Flexible benefits

Job summary

ICON, the world’s largest & most comprehensive clinical research organisation, is seeking a Principal Medical Writer to join our team. You will lead the creation and editing of protocols, CSRs, IBs, and submissions, ensuring clarity and regulatory compliance.

Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs; plan development programs; contribute to publications; mentor junior writers; support a culture of excellence.

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with 5–7 years of medical writing experience.
• Ability to interpret and summarize complex clinical trial data and scientific findings.
• Strong regulatory knowledge (ICH-GCP, FDA, EMA) and experience interacting with regulatory agencies.
• Experience leading publication planning, abstracts, posters, and manuscripts.
• Ability to mentor junior medical writers and foster learning within a team.

Responsibilities

• Lead the preparation, review, and editing of study documents (protocols, CSRs, IBs, regulatory submissions).
• Collaborate with cross-functional teams to interpret trial data and communicate insights in writing.
• Plan and execute clinical development programs, providing strategic scientific input.
• Contribute to development of publication plans, abstracts, posters, and manuscripts.
• Mentor and coach junior medical writers, promoting best practices and continuous learning.

Skills

Excellent writing and editing

Cross-functional collaboration

Interpreting complex clinical data

Mentoring junior writers

Regulatory knowledge (ICH-GCP, FDA,EMA

Deadline-driven multitasking

Education

Advanced degree in Life Sciences or related field

Job description

As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing

• Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards.
• Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings, and communicate key insights in written form.
• Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
• Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences, disseminating study results and scientific insights to the broader scientific community.
• Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.

You Are:

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 5-7 years of experience in medical writing within the pharmaceutical, biotechNlogy, or contract research organization (CRO) industry.
• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences.
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process.
• Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON:

At ICON, inclusion & belonging are fundamental to our culture and values. 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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.