Senior Medical Writer: Regulatory & Publications Lead

KCR Placement; 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

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.