Senior Medical Writer

Senior Medical Writer
- Remote

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.

• 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, disseminating study results and scientific insights to the broader scientific community.
• Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.

Your profile

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a 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, with excellent writing, editing, and proofreading skills, and the 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, and 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 and prioritizing tasks based on project timelines and deliverables.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes.

• Diriger la préparation, la révision et l’édition des documents d’études cliniques, notamment les protocol es d’essais cliniques, les rapports d’études cliniques (Clinical Study Reports – CSR), les brochures de l’investigateur (Investigator Brochures – IB) ainsi que les dossiers de soumission réglementaire, en veillant à leur exactitude scientifique, leur clarté rédactionnelle et leur conformité aux lignes directrices réglementaires et aux standards de l’industrie.

• Collaborer étroitement avec des équipes pluridisciplinaires, incluant la recherche clinique, la biostatistique, les affaires réglementaires et les affaires médicales, afin d’interpréter et d’analyser les données issues des essais cliniques, de synthétiser les résultats scientifiques et de communiquer les messages clés de manière structurée et compréhensible par écrit.

• Participer à la planification et à l’exécution des programmes de développement clinique, en apportant une contribution stratégique et une expertise scientifique pour soutenir la conception, la conduite et l’interprétation des études cliniques…