Senior Medical Writer

ICON Strategic Solutions; United States; On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme (

Job summary

ICON Strategic Solutions seeks an experienced Medical Writer to own and deliver complex clinical writing projects, including protocols, CSRs, IBs, and submissions. You will work with cross-functional teams to interpret data and ensure high-quality publications and submissions.

The role emphasizes mentorship, scientific leadership, and collaboration within a fast-paced environment, with competitive compensation and benefits in the United States.

Qualifications

• Strong ability to interpret and summarize complex clinical trial data and findings.
• Excellent writing, editing, and proofreading skills.
• Solid understanding of regulatory requirements (ICH-GCP, FDA, EMA) for clinical documents and publications.
• Ability to manage multiple projects in a fast-paced, deadline-driven environment.
• Excellent interpersonal and communication skills to collaborate with cross-functional teams.

Responsibilities

• Lead preparation, review, and editing of clinical study documents (protocols, CSRs, IBs, regulatory submissions).
• Collaborate with clinical research, biostatistics, regulatory, and medical affairs to interpret trial data.
• Plan and contribute to development programs, providing scientific input for study design and interpretation.
• Contribute to publication plans, abstracts, posters, and manuscripts for journals and conferences.
• Mentor and coach junior medical writers to foster excellence and collaboration.

Skills

Medical writing

Editing

Proofreading

Regulatory understanding

Education

Bachelor's degree in a scientific discipline or healthcare-related field

Job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Do

You will take ownership of medical writing deliverables, applying your expertise to complex challenges.

Key Responsibilities Include

• 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
• 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
• 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
• 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.

Your Profile

You will have a strong foundation in medical writing, with the experience to work independently and guide others.

Required Qualifications And Experience

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills
• 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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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 or submit a request here