Senior Medical Writer shaping key clinical and regulatory documents at Thermo Fisher Scientific. Collaborating with teams to drive strategy, quality, and execution of early - phase programs.
About the role
- 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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