Senior Medical Writer at ICON plc leading development and execution of medical writing strategies for clinical research projects. Contributing to new treatments and therapies through documentation and collaboration.
Responsibilities
Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions
Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs
Participating in the planning and execution of clinical development programs
Contributing to the development of publication plans, abstracts, posters, and manuscripts
Mentoring and coaching junior medical writers, providing guidance on best practices.
Requirements
Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
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 (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
Demonstrated ability to work effectively in a fast-paced, deadline-driven environment
Excellent interpersonal and communication skills.
Benefits
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
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