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For Companies At a Glance
- Tasks: Lead the development of high-complexity clinical regulatory documents for life-changing treatments.
- Company: Join Fortrea, a mission-driven company in the pharma industry.
- Benefits: Remote work options, comprehensive training, and career growth opportunities.
- Why this job: Make a real impact on patient care while advancing your career in medical writing.
- 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.
The predicted salary is between 36000 - 60000 £ 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.
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 Leeds employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer in Leeds
✨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 project management skills. Be ready to discuss how you’ve led teams and managed complex writing tasks, as this is key for the Senior Medical Writer role.
✨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 Leeds
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Medical Writer role. Highlight your regulatory writing experience and any specific documents you've worked on, like CSRs or Protocols. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical writing and how your experience makes you the perfect fit for our team. Don’t forget to mention your ability to lead projects and collaborate with diverse teams.
Showcase Your Communication Skills: Since this role involves coordinating with various teams, it's essential to demonstrate your communication skills in your application. Share examples of how you've successfully managed discussions or resolved conflicts in past projects.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our mission at Fortrea!
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 thoroughly understand the types of documents you'll be working on. Familiarise yourself with their structure and purpose, so you can confidently discuss your experience and how it aligns with the role.
✨Showcase Your Leadership Skills
This role requires you to lead projects and coordinate teams. Prepare examples from your past experiences where you've successfully led a writing project or facilitated team discussions. Highlight your ability to manage conflicting comments and drive consensus among diverse stakeholders.
✨Communicate Clearly and Effectively
Excellent communication is key in this position. Practice articulating your thoughts clearly, especially when discussing complex medical data. Be ready to explain how you ensure alignment with sponsor goals and maintain project status across teams during the interview.
✨Demonstrate Your Adaptability
The job requires flexibility and the ability to adapt to different environments and therapeutic areas. Think of instances where you've had to adjust your approach based on new information or changing circumstances. Share these stories to show that you're ready to take on augmented responsibilities.
