Senior Medical Writer

Overview

As a Senior Medical Writer, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing:

1. Develop regulatory documents for submission to global regulatory agencies, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, following ICH and other international guidelines, standards, and Incyte authoring standards, while adhering to study/project timelines and corporate objectives.
2. Manage medical writing projects by developing timelines in collaboration with study/project teams and communicating with cross-functional team members to ensure awareness of review cycles and expectations.
3. Participate in cross-functional meetings to provide input on medical writing deliverables, timelines, and processes necessary for the completion of regulatory documents.
4. Review related documents such as Protocols and Statistical Analysis Plans, as appropriate.

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Qualifications

You are:

• Holding a Bachelor's degree in a life science discipline; a Master’s degree is preferred. At least 6 years of medical writing experience in the biopharmaceutical/CRO industry is required.
• Experienced in regulatory writing, including Clinical Study Reports, IBs, and Protocols.
• Oncology experience is a plus.
• Proficient in understanding and applying domestic and international regulatory requirements, with knowledge of therapeutic areas across all phases of clinical development.
• Capable of organizing and communicating clinical information effectively.
• Possessing strong communication, organizational, time management, and project management skills.

What ICON can offer you: Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme, TELUS Health, providing 24/7 support through a network of professionals
• Life assurance
• Flexible country-specific benefits, such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

At ICON, inclusion & belonging are fundamental. We are committed to providing an inclusive, accessible environment free of discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.