# Senior Medical Writer

**Company**: ICON
**Location**: Dublin, Ireland
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Ireland-Dublin/Senior-Medical-Writer_JR162113?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ab10a0e0-b60

## 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 patients.

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.

**Responsibilities**

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.

**Rewards & Benefits**

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

- Competitive base salary and performance related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- medical writing
- clinical research
- regulatory affairs
- scientific publications
- ICH-GCP
- FDA
- EMA

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