Senior Medical Writer

ICON; Dublin; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks Global EAP

Life assurance

Flexible benefits

Job summary

ICON is a global healthcare intelligence and clinical research organization dedicated to bringing new medicines to patients faster. As a Senior Medical Writer, you will lead medical writing strategies for clinical research projects and work with cross-functional teams to deliver high-quality regulatory documents and publications.

You will own deliverables such as CSRs, IBs, and regulatory submissions, while mentoring junior writers and ensuring compliance with ICH-GCP, FDA, and EMA standards.

Qualifications

• 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 (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.

Responsibilities

• Lead the preparation, review, and editing of clinical study documents, including protocols, CSRs, IBs, and regulatory submissions, ensuring accuracy and clarity.
• Collaborate with cross-functional teams to interpret clinical trial data and summarize scientific findings.
• Contribute to planning and execution of clinical development programs, providing strategic input and scientific expertise.
• Develop publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and conferences.
• Mentor and coach junior writers, guiding best practices, writing techniques, and scientific principles.

Skills

Medical writing

Regulatory writing

ICH-GCP knowledge

Data interpretation

Scientific editing

Education

Bachelor's degree in a relevant scientific discipline

Job description

Make an impact from data to publication. As a Senior Medical Writer, you'll drive the delivery of high-quality regulatory documents and scientific publications, partnering with global cross-functional teams to bring life-changing therapies closer to patie

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Senior Medical Writer at ICON, you will lead the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.

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.

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

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