Senior Medical Writer

ICON Clinical Research; España; Remote; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee Assistance Program

Life assurance

Flexible benefits

Job summary

ICON Clinical Research is seeking a Senior Medical Writer to lead medical writing strategies for clinical projects. You will own regulatory documents, contribute to protocol and CSR development, and mentor junior writers while coordinating with study teams to meet timelines.

The role requires strong regulatory expertise, high-quality writing, and collaboration across cross-functional teams to ensure submission readiness and regulatory compliance in a sponsor-dedicated environment.

Qualifications

• 3–5 years of experience as regulatory writer.
• Mandatory protocol writing experience in phase II or III; CSR experience is a plus.
• Bachelor's degree in a relevant scientific discipline.
• Ability to interpret and summarize complex clinical data with strong writing skills.
• Solid understanding of regulatory requirements (ICH-GCP, FDA, EMA) and agency interactions.

Responsibilities

• Lead development and execution of medical writing strategies for clinical projects.
• Independently produce clinical/regulatory documents (e.g., protocols, CSR).
• Analyse data and apply lean writing to documents.
• Serve as the study team's primary contact for document planning and timelines.
• Mentor junior medical writers and promote best practices within the team.

Skills

Regulatory writing

Clinical data interpretation

Editing & proofreading

Team collaboration

Regulatory agency interactions

Education

Bachelor's degree in a scientific field

Job description

Senior Medical Writer

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.

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:

• Independently produces clinical and regulatory documents in collaboration with Principal/Senior Principal MW assigned to the program. These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports . This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.

• Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.

• Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.

• Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.

• 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:

• 3-5 years of experience as regulatory writer

• Regulatory experience: Mandatory protocol writing experience in phase II or III, also CSR experience is good to have

• 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.

• 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.

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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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable‑accommodations)