Senior Medical Writer
- Multiple US Locations, Burlington
- Medical Writing
- ICON Strategic Solutions
- Remote
Senior Talent Acquisition Business Partner
- Icon Strategic Solutions
About the role
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.
Rédacteur Médical Senior – Télétravail
ICON plc est une organisation mondiale de premier plan dans le domaine de l’intelligence en santé et de la recherche clinique. Nous sommes fiers de favoriser un environnement inclusif qui stimule l’innovation et l’excellence, et nous vous invitons à nous rejoindre dans notre mission visant à façonner l’avenir du développement clinique.
Nous recherchons actuellement un Rédacteur Médical Senior pour rejoindre notre équipe diversifiée et dynamique. En tant que Rédacteur Médical Senior chez ICON, vous jouerez un rôle clé dans la direction et la mise en œuvre de stratégies de rédaction médicale pour des projets de recherche clinique, contribuant ainsi à l’avancement de traitements et thérapies innovants.
Vos principales responsabilités :
Diriger la préparation, la révision et la rédaction de documents d’études cliniques, notamment les protocoles d’études cliniques, les rapports d’études cliniques (CSRs), les brochures investigateurs (IBs) et les dossiers de soumission réglementaire, en veillant à leur exactitude, leur clarté et leur conformité aux directives réglementaires et aux normes industrielles.
Collaborer étroitement avec des équipes pluridisciplinaires, notamment la recherche clinique, la biostatistique, les affaires réglementaires et les affaires médicales, afin d’interpréter et d’analyser les données d’essais cliniques, de résumer les résultats scientifiques et de communiquer les principales conclusions de manière claire et structurée.
Participer à la planification et à la mise en œuvre de programmes de développement clinique, en apportant un soutien stratégique et une expertise scientifique pour concevoir, conduire et interpréter les études et initiatives de recherche.
Contribuer à l’élaboration de plans de publication, de résumés, d’affiches et de manuscrits pour soumission à des revues scientifiques à comité de lecture et pour présentation lors de congrès scientifiques, afin de diffuser les résultats et connaissances scientifiques à la communauté médicale.
Encadrer et accompagner les rédacteurs médicaux juniors, en leur fournissant des conseils sur les meilleures pratiques, les techniques de rédaction et les principes scientifiques, et 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 dans un 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).
Excellente maîtrise de l’interprétation et de la synthèse de données d’essais cliniques complexes, de résultats de recherche scientifique et d’analyses statistiques, avec des compétences avérées en rédaction, révision et correction, et la capacité à communiquer des concepts scientifiques à des publics variés.
Solide compréhension des exigences réglementaires (par ex. ICH-GCP, FDA, EMA) encadrant la préparation et la soumission de documents cliniques et de publications, ainsi qu’une expérience dans les interactions avec les autorités réglementaires lors des processus de revue et d’approbation.
Capacité démontrée à travailler efficacement dans un environnement dynamique et exigeant, à gérer plusieurs projets simultanément et à hiérarchiser les priorités en fonction des échéances et livrables.
Excellentes aptitudes interpersonnelles et en communication, avec la capacité de collaborer efficacement avec des équipes pluridisciplinaires, de bâtir des relations solides avec les parties prenantes et d’influencer les processus décisionnels.
Ce que ICON peut vous offrir :
Notre succès dépend de la qualité de nos collaborateurs. C’est pourquoi nous avons fait de la création d’une culture diversifiée, qui valorise la performance et développe les talents, une priorité.
En plus d’un salaire compétitif, ICON propose une large gamme d’avantages supplémentaires conçus pour favoriser votre bien-être et votre équilibre entre vie professionnelle et vie personnelle, ainsi que celui de votre famille.
Exemples d’avantages :
Différents congés annuels attractifs
Une gamme d’assurances santé adaptées à vos besoins et à ceux de votre famille
Des dispositifs d’épargne retraite compétitifs pour planifier votre avenir en toute confiance
Un programme mondial d’assistance aux employés (TELUS Health), offrant un accès 24h/24 à un réseau international de plus de 80 000 professionnels spécialisés pour soutenir votre bien-être et celui de votre famille
Assurance-vie
Des avantages flexibles spécifiques à chaque pays, tels que les chèques garde d’enfants, les programmes d’achat de vélos, les abonnements à prix réduit en salle de sport, les passes de transport subventionnés, les bilans de santé, entre autres.
Visitez notre site carrières pour en savoir plus sur les avantages qu’ICON propose.
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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 or submit a request here
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.
Are you a current ICON Employee? Please click here to apply
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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