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ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.
Job Responsibility:
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, and compliance with regulatory guidelines and industry standards
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, and communicate key insights in written form
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
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
Ability to communicate scientific concepts to diverse audiences
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
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
Excellent interpersonal and communication skills
Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments