Senior Medical Writer

ICON plc • Blue Bell, SD

3d

About The Position

At ICON Strategic Solutions, the Senior Medical Writer works in a sponsor-dedicated model, supported by ICON’s global expertise. The role leads the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of treatments and therapies. The writer takes ownership of medical writing deliverables and applies expertise to complex challenges.

The position involves leading the preparation, review, and editing of clinical study documents and regulatory submissions; collaborating with cross-functional teams to interpret clinical trial data and summarize scientific findings; and providing strategic input and scientific expertise to clinical development programs. It also contributes to publication plans and scientific materials, and mentors junior medical writers.

ICON describes a competitive total rewards package intended to support health, wellbeing, and career development. Benefits may vary by role and location. Employment is contingent upon having the legal right to work in the country where the role is based.

Requirements

• 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.
• Excellent writing, editing, and proofreading skills.
• Strong understanding of regulatory requirements, including ICH-GCP, FDA, and EMA requirements, governing clinical documents and publications.
• Experience interacting with regulatory agencies during review and approval processes.
• Ability to work effectively in a fast-paced, deadline-driven environment, manage multiple projects simultaneously, and prioritize tasks based on timelines and deliverables.
• Excellent interpersonal and communication skills, including the ability to collaborate with cross-functional teams, build relationships with key stakeholders, and influence decision-making.

Responsibilities

• Lead the preparation, review, and editing of clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy and clarity.
• Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams to interpret and analyze clinical trial data and summarize scientific findings.
• Participate in planning and executing clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
• Contribute to publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and scientific conferences.
• Mentor and coach junior medical writers on best practices, writing techniques, and scientific principles, fostering excellence, collaboration, and continuous learning.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior