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- Tasks: Lead the creation of complex clinical regulatory documents for life-changing treatments.
- Company: Join Fortrea, a mission-driven pharma company dedicated to patient care.
- Benefits: Enjoy remote work flexibility, competitive salary, and career development opportunities.
- Why this job: Make a real impact in healthcare by delivering essential documents that accelerate treatment access.
- Qualifications: Advanced degree in life sciences and 4+ years of regulatory medical writing experience.
- Other info: Collaborate with global teams and shape your own career path in a diverse environment.
The predicted salary is between 48000 - 72000 £ per year.
Overview: Sponsor-dedicated. Full time. Remote in the UK, Greece, Spain or Portugal. We are on a mission to deliver solutions that bring life-changing treatments to patients faster. We are seeking an experienced Senior Regulatory Medical Writer to lead authoring and development of high complexity clinical regulatory documents that are critical to the strategic projects of our partner.
What You Will Do: Embedded in the team of one of the world´s leading pharma companies, you will be one of the primary Regulatory Medical Writers, project leading the Development Cycle for high-complexity Phase II-IV clinical regulatory documents. We´ll trust you to spearhead the entire process, from initial planning and coordination through all stages of development, culminating in the final delivery to the sponsor. From the variety of documents you will work on (Investigator´s Brochures, Safety Narratives, ICFs, Efficacy Summaries, Regulatory Responses, etc.), your contribution will be essential.
- Protocols and Clinical Study Reports (CSRs)
With Minimal Supervision – Planning Stage: Lead kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward. Conduct communication strategy meetings, to consolidate contributions from experts to produce a cohesive Shell Skeleton Report. Facilitate comment resolution meetings, to manage conflicting comments early and ensure smooth protocol development.
During Document Development: Maintain alignment with sponsor goals, project status and milestones across all teams. Foster regular communication with functional leads/reviewers to streamline document development (getting inputs timely, consolidating contributions, answering questions).
Once Final Data Is Received: Critically interpret raw study data (efficacy, exposure, end-point, safety, etc.) into clear concise language in Protocols and CSRs.
Who You Will Work With: You will coordinate functional leads and reviewers from the Biostatistics, Data Management, Programming, Clinical Leadership and Project Physician teams. Additionally, you will engage with Medical Writing teams across Europe, and also the Americas and Asia-Pacific.
Locations: This is a full-time, permanent job. Our ideal locations are: UK, Spain, Portugal and Greece.
Your Experience: Advanced degree in life-sciences (PhD or Masters). Minimum 4 years of regulatory medical writing experience, including at least 2 years as medical writing project lead. Extensive experience and proficiency in writing and leading development of CSRs and Protocols.
Personal/Team Skills: You´ll 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. 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 client´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.
A UNIQUELY DIVERSE CAREER: At Fortrea, we empower you to shape your own career path. Whether you are passionate about the medical writing scientific side, or aspire to leadership roles, we provide comprehensive training, management support, a network of SME’s and KOL’s and opportunities to help you thrive. Your aspirations drive your journey with us.
Senior Medical Writer in London employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical writing field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Showcase your expertise! Create a portfolio of your best work, especially those high-complexity documents you’ve authored. This will give potential employers a taste of what you can bring to the table.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of clinical regulatory documents. Be ready to discuss your past projects and how you’ve led teams through the development cycle.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Medical Writer in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Senior Medical Writer role. Highlight your regulatory writing experience and any leadership roles you've had in projects to show us you're the right fit.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about medical writing and how your background aligns with our mission at Fortrea. Be genuine and let your personality come through!
Showcase Your Communication Skills: Since this role involves coordinating with various teams, make sure to demonstrate your excellent communication skills in your application. Share examples of how you've successfully led discussions or resolved conflicts in past projects.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep track of your application and ensures you get all the updates about your journey with us!
How to prepare for a job interview at Fortrea
✨Know Your Documents Inside Out
As a Senior Medical Writer, you'll be dealing with complex documents like CSRs and Protocols. Make sure you understand the nuances of these documents and can discuss their structure and purpose confidently. Brush up on any recent changes in regulatory guidelines that might affect your writing.
✨Showcase Your Project Leadership Skills
This role requires you to lead projects with minimal supervision. Prepare examples from your past experiences where you've successfully led a team or project. Highlight how you managed timelines, coordinated with different teams, and resolved conflicts to keep the project on track.
✨Communicate Clearly and Effectively
Excellent communication is key in this role. During the interview, practice articulating your thoughts clearly and concisely. Be ready to demonstrate how you would facilitate meetings and ensure all stakeholders are aligned, especially when discussing complex medical data.
✨Demonstrate Adaptability and Collaboration
You'll be working with diverse teams across various locations. Share examples of how you've adapted to different working styles and collaborated effectively with cross-functional teams. Emphasise your ability to integrate into new environments and take on augmented responsibilities.
