Principal Medical Writer

Fortrea; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in the UK is seeking a Principal Medical Writer to lead the development of complex clinical regulatory documents for a major client. This role involves collaborating with stakeholders, managing writing projects, and ensuring high-quality document delivery. The ideal candidate has an advanced degree, at least 6 years of eCTD submission writing experience, and a passion for medical writing. The position offers flexibility to work remotely across various regions.

Qualifications

• Minimum 6 years eCTD submission writing experience.
• 3 years as medical writing project lead.
• Experience leading content development for clinical summaries.

Responsibilities

• Lead authoring of complex clinical regulatory documents.
• Coordinate writing projects and facilitate discussions.
• Collaborate with cross-functional teams to drive document development.

Skills

Clinical regulatory document development

Stakeholder management

Medical writing

Team collaboration

Education

PhD or Masters

Job description

Overview

Full time. Remote in the UK Spain Portugal or Greece.

We are on a mission to deliver solutions that bring life-changing treatments to patients faster. We are seeking an experienced Principal Medical Writer to lead authoring and development of high complexity clinical regulatory documents. You will work fully dedicated to one of our key strategic clients, a Top 10 global pharmaceutical company.

This is why we need you. Join Fortrea. Your job matters.

WHAT YOU WILL DO

You will work sponsor-dedicated, embedded on their team. Under this framework you will act as an expert contributor on our partner"s project teams at portfolio level. You will use your expertise to write, advise and coordinate development of complex clinical regulatory documents including:

• 2.73 Efficacy and 2.74 Safety summaries
• Clinical Study Protocols
• Clinical Study Reports
• Investigator Brochures
• Full document overview in CTD/eCTD format for regulatory submissions worldwide

Strategist.

This job is tailor-made for Medical Writers passionate about leading development of key documents that inform and align with project strategy.

Project Manager.

You will be the nexus where multiple teams" expertise converge. You will leverage your experience to manage writing projects, coordinate and collaborate with stakeholders, steer discussion, drive consensus and facilitate decision-making to propel the document development cycle forward.

YOU NEED TO BRING

• Advanced degree (PhD or Masters)
• Minimum 6 years eCTD submission writing experience including 3 years as medical writing project lead
• Experience and proficiency in writing and leading development of a variety of clinical regulatory medical writing deliverables including extensive experience leading content development for efficacy or safety clinical summary modules and drug applications across different regions
• Proven experience leading stakeholders/project teams through submission document development

TEAM LEAD SKILLS

To drive development of documents of this scale forward this role requires visibility, proactivity, collaboration/teamwork and excellent communication skills. You must be comfortable leading team discussions, managing complex medical writing tasks and processes, engaging with a variety of stakeholders and confidently contributing your expertise based on experience.

Integration within the partner"s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.

A UNIQUELY DIVERSE CAREER

At Fortrea your career path is yours to shape. We empower our team to steer their own development. Where are you in your career journey?

• If you thrive in medical writing and want to remain deeply involved in science with high-profile clients Fortrea is your destination.
• If you are coming to a point where you want to try management we offer comprehensive training and support to prepare you for leadership roles.

Your aspirations drive your journey with us.

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Learn more about our EEO & Accommodations request here.

Required Experience:

Staff IC