Sr. Medical Writer

ICON; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

ICON, a leading clinical research organization, is seeking a Senior Medical Writer to prepare and review clinical study documents and collaborate with cross-functional teams. The ideal candidate will hold an advanced degree and have 3-5 years of medical writing experience, with a strong understanding of regulatory requirements. ICON offers competitive salaries and a range of benefits to support employee well-being and work-life balance.

Benefits

Various annual leave entitlements

Health insurance options

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible country-specific benefits

Qualifications

• Minimum 3-5 years of experience in medical writing.
• Proficient in interpreting clinical trial data.
• Strong understanding of regulatory requirements.

Responsibilities

• Lead preparation and review of clinical study documents.
• Collaborate with cross-functional teams to analyze data.
• Mentor junior medical writers and foster a culture of excellence.

Skills

Writing

Editing

Communication

Interpersonal Skills

Education

Advanced degree in Life Sciences, Pharmacy, Medicine

Job description

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

What you will be doing

1. 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.
2. 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.
3. 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.
4. 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.
5. 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:

1. Hold an advanced degree in Life Sciences, Pharmacy, Medicine, or a related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
2. Proficient 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.
3. Have a 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.
4. Demonstrate the ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.
5. Possess 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 designed to support your well-being and work-life balance. Examples include:

• Various annual leave entitlements
• A range of health insurance options for you and your family
• Competitive retirement planning offerings to maximize savings
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to support professionals
• Life assurance
• Flexible country-specific benefits, including childcare vouchers, bike schemes, discounted gym memberships, and more

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are core to our culture. We are committed to providing an inclusive environment free of discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you need a reasonable accommodation during the application process or to perform the essential functions of the role, please contact us through the provided link: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for at ICON, whether for this or other roles.