Job Description
Principal Medical Writer
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 Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ submissions to regulatory authorities and ensuring compliance with industry standards.
What You Will Be Doing: • Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
• Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
• Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.
• Mentoring and training junior medical writers, fostering a culture of excellence and professional growth.
• Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs.
Your Profile: • Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
• Significant experience in medical writing, particularly in regulatory submissions and clinical documentation.
• Strong understanding of regulatory requirements and industry standards for clinical writing.
• Exceptional writing and editing skills, with a keen eye for detail and clarity.
• Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.
• A commitment to maintaining high standards of quality and compliance in all medical writing activities.
Nous sommes actuellement à la recherche d’un(e) Rédacteur(trice) Médical(e) Principal(e) pour rejoindre notre équipe diversifiée et dynamique. En tant que Rédacteur Médical Principal chez ICON, vous serez responsable de diriger l’élaboration de documents réglementaires et cliniques de haute qualité, visant à communiquer efficacement des informations scientifiques et médicales. Votre expertise en rédaction médicale sera essentielle pour soutenir les soumissions de nos clients auprès des autorités réglementaires et garantir la conformité aux normes de l’industrie.
Vos missions : - Diriger la préparation et la révision des rapports d’études cliniques, des protocoles et d’autres documents réglementaires, en veillant à leur exactitude et à leur clarté.
- Collaborer avec des équipes pluridisciplinaires, notamment la recherche clinique, la biostatistique et les affaires réglementaires, afin de recueillir et de synthétiser les informations nécessaires à la rédaction des documents.
- Fournir des conseils sur les meilleures pratiques en matière de rédaction médicale et garantir le respect des exigences réglementaires ainsi que des normes internes.
- Encadrer et former les rédacteurs médicaux juniors, en favorisant une culture d’excellence et de développement professionnel.
- Se tenir informé(e) des tendances du secteur et des lignes directrices réglementaires afin d’orienter les pratiques rédactionnelles et de maintenir un niveau de qualité élevé.
Votre profil : - Diplôme avancé en sciences de la vie, médecine ou dans un domaine connexe ; des certifications pertinentes sont un plus.
- Expérience significative en rédaction médicale, en particulier dans les soumissions réglementaires et la documentation clinique.
- Solide compréhension des exigences réglementaires et des normes de l’industrie en matière de rédaction clinique.
- Excellentes compétences rédactionnelles et de révision, avec un grand souci du détail et de la clarté.
- Très bonnes aptitudes à la communication et au travail en équipe, permettant une collaboration efficace avec des interlocuteurs variés.
- Engagement fort à maintenir des normes élevées de qualité et de conformité dans toutes les activités de rédaction médicale.
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
Job Tags
Remote job, Flexible hours,