Job Description

Principal 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 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 c

ommunication 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 recherchons actuellement un(e) Rdacteur(trice) Mdical(e) Principal(e) pour rejoindre notre quipe diversifie et dynamique. En tant que Rdacteur Mdical Principal chez ICON, vous serez responsable de diriger le dveloppement de documents rglementaires et cliniques de haute qualit, communiquant efficacement des informations scientifiques et mdicales. Votre expertise en rdaction mdicale sera essentielle pour soutenir les soumissions de nos clients auprs des autorits rglementaires et garantir la conformit aux normes de l'industrie.

Vos Responsabilits

• Diriger la prparation et la rvision des rapports d'tudes cliniques, des protocoles et d'autres documents rglementaires afin d'en assurer l'exactitude et la clart.
• Collaborer avec des quipes pluridisciplinaires, notamment la recherche clinique, la biostatistique et les affaires rglementaires, afin de recueillir et synthtiser les informations ncessaires l'laboration des documents.
• Fournir des conseils sur les meilleures pratiques en rdaction mdicale et veiller au respect des exigences rglementaires ainsi que des normes internes.
• Encadrer et former les rdacteurs mdicaux juniors, en favorisant une culture d'excellence et de dveloppement professionnel.
• Se tenir inform(e) des tendances du secteur et des lignes directrices rglementaires afin d'enrichir les pratiques rdactionnelles et de maintenir des livrables de haute qualit.

Votre Profil

• Diplme avanc en sciences de la vie, en mdecine ou dans un domaine connexe ; les certifications pertinentes sont un atout.
• Exprience significative en rdaction mdicale, notamment dans les soumissions rglementaires et la documentation clinique.
• Solide comprhension des exigences rglementaires et des normes de l'industrie en matire de rdaction clinique.
• Excellentes comptences rdactionnelles et ditoriales, avec un sens aigu du dtail et de la clart.
• Excellentes aptitudes en communication et en relations interpersonnelles, permettant une collaboration efficace avec des quipes et parties prenantes varies.
• Engagement maintenir des standards levs de qualit et de conformit dans toutes les activits de rdaction mdicale.

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

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