Senior Medical Writer in Swansea

ICON is a global 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.

We are currently seeking a Senior or Principal Medical Writer to join our diverse and dynamic team. In this role, 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:

• Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents.
• May assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission.
• Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area.
• Participates on relevant project teams and task forces, providing functional and cross-functional guidance on document preparation.
• Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
• Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
• Ensures resolution of issues through review and substantive editing of contributions.
• Manages deliverables and preparation of documents for submission to regulatory agencies, ensuring consistency of content and adherence to regulatory requirements.
• Represents Medical Writing on cross-functional teams and task forces.
• Acts as a key Medical Point of contact for clinical regulatory strategy.
• Serves as lead writer for important regulatory response documents and key components of regulatory submissions.
• Provides leadership on functional teams addressing requirements or issues related to document preparation and production.

The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.

Your Profile:

• Bachelor’s degree in science or health profession required.
• At least 5 years of experience writing for pharma or biotechnology preferred; 3+ years of electronic documents and submissions required.
• Experience with writing key documents included in major international regulatory submissions required.
• Knowledge and understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production.
• Well-developed oral and written communication skills; ability to clearly present technical information.
• Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams.

Rewards & Benefits:

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Inclusion and Accessibility: ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.