10 sep
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Barcelona
Principal Medical Writer
ICON is a general healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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.
What You Will Do:
You will oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations.
Key responsibilities include:
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
Acting as a lead medical writer for complex projects and leading clinical/regulatory marketing approval applications for new biologics and drugs
The position includes all duties of a Senior Medical Writer, as well as leadership of regulatory approval application writing
Your Profile:
You will have solid experience in medical writing, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
A bachelor's degree in life sciences, pharmacy, or a related discipline
Significant experience in medical writing, particularly in regulatory submissions and clini
📌 Principal Medical Writer (Barcelona)
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📍 Barcelona