Lead 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 inNvative treatments and therapies.

What you will be doing

• 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, biotechNlogy, 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.

Nous recherchons actuellement un Senior Medical Writer pour rejoindre notre équipe diversifiée et dynamique. En tant que Senior Medical Writer au sein d'ICON, vous jouerez un rôle essentiel dans la direction du développement et de l'exécution des stratégies de rédaction médicale pour les projets de recherche clinique, contribuant ainsi à l'avancement de traitements et thérapies innovants.

Vos responsabilités

• Diriger la préparation, la relecture et la rédaction des documents d'études cliniques, notamment les protocoles d'étude clinique, les rapports d'étude clinique (CSRs), les brochures investigateurs (IBs) et les dossiers de soumission réglementaire, en garantissant l'exactitude, la clarté et la conformité aux lignes directrices réglementaires et aux normes de l'industrie.
• Collaborer étroitement avec des équipes transversales, notamment la recherche clinique, la biostatistique, les affaires réglementaires et les affaires médicales, afin d'interpréter et d'analyser les données des essais cliniques, de résumer les résultats scientifiques et de communiquer les informations clés sous forme écrite.
• Participer à la planification et à l'exécution des programmes de développement clinique, en apportant une expertise scientifique et des contributions stratégiques pour soutenir la conception, la conduite et l'interprétation des études cliniques et des initiatives de recherche.
• Contribuer au développement des plans de publication, résumés, posters et manuscrits destinés aux revues à comité de lecture et aux conférences scientifiques, afin de diffuser les résultats des études et les informations scientifiques à la communauté scientifique.
• Encadrer et accompagner les rédacteurs médicaux juniors, en fournissant des conseils sur les meilleures pratiques, les techniques de rédaction et les principes scientifiques, tout en favorisant une culture d'excellence, de collaboration et d'apprentissage continu au sein de l'équipe de rédaction médicale.

Votre profil

• Diplôme avancé en sciences de la vie, pharmacie, médecine ou domaine connexe, avec un minimum de 3 à 5 ans d'expérience en rédaction médicale dans l'industrie pharmaceutique, biotechnologique ou au sein d'une CRO (Contract Research Organization).
• Expertise dans l'interprétation et la synthèse de données complexes d'essais cliniques, de résultats scientifiques et d'analyses statistiques, avec d'excellentes compétences en rédaction, révision et relecture, et la capacité de communiquer des concepts scientifiques à des publics variés.
• Solide compréhension des exigences réglementaires (par ex. ICH-GCP, FDA, EMA) relatives à la préparation et à la soumission de documents cliniques et de publications, ainsi qu'une expérience d'interaction avec les autorités réglementaires pendant les processus d'examen et d'approbation.
• Capacité démontrée à travailler efficacement dans un environnement dynamique et exigeant, à gérer plusieurs projets simultanément et à hiérarchiser les tâches en fonction des délais et livrables.
• Excellentes compétences interpersonnelles et en communication, avec la capacité de collaborer efficacement avec des équipes transversales, d'établir des relations avec les parties prenantes clés et d'influencer les processus décisionnels.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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.

Visit our

careers site

to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.