Principal Medical Writer
Principal Medical Writer

Principal Medical Writer

Full-Time 48000 - 72000 £ / year (est.) Home office possible
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At a Glance

  • Tasks: Lead the development of complex clinical regulatory documents for a top global pharmaceutical client.
  • Company: Fortrea, a mission-driven company focused on delivering life-changing treatments.
  • Benefits: Remote work options, career development opportunities, and a supportive team environment.
  • Why this job: Make a real impact in medical writing while collaborating with industry leaders.
  • Qualifications: Advanced degree and extensive experience in eCTD submission writing required.
  • Other info: Shape your own career path with comprehensive training and support for leadership roles.

The predicted salary is between 48000 - 72000 £ per year.

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.

Role

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:

  • Efficacy and Safety summaries
  • Clinical Study Protocols
  • Clinical Study Reports
  • 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.

Qualifications

  • 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. 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.

Principal Medical Writer employer: Fortrea

At Fortrea, we are committed to fostering a dynamic and inclusive work environment where your contributions truly matter. As a Principal Medical Writer, you will enjoy the flexibility of remote work across the UK, Spain, Portugal, or Greece, while collaborating closely with a Top 10 global pharmaceutical client. We prioritise your professional growth, offering tailored training and leadership opportunities to help you shape your career path in a supportive culture that values innovation and teamwork.
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Contact Detail:

Fortrea Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Principal Medical Writer

✨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 open doors and lead to opportunities that aren’t even advertised.

✨Tip Number 2

Showcase your expertise! Create a portfolio of your best work, especially those complex clinical regulatory documents. When you get the chance to chat with potential employers, share your insights and experiences to demonstrate your value.

✨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. We want to see how you can drive consensus and facilitate decision-making!

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about joining our mission to bring life-changing treatments to patients faster.

We think you need these skills to ace Principal Medical Writer

Medical Writing
Clinical Regulatory Documents
eCTD Submission Writing
Project Management
Stakeholder Engagement
Team Leadership
Communication Skills
Collaboration
Adaptability
Strategic Thinking
Problem-Solving
Attention to Detail
Proactivity
Decision-Making

Some tips for your application 🫡

Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your eCTD submission writing experience and any leadership roles you've held in medical writing projects.

Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about medical writing and how your background aligns with our mission at Fortrea. Be sure to mention your experience with complex clinical regulatory documents!

Showcase Your Teamwork Skills: Since collaboration is key in this role, provide examples of how you've successfully worked with diverse teams in the past. We want to see your ability to drive consensus and facilitate discussions.

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 this exciting opportunity at Fortrea!

How to prepare for a job interview at Fortrea

✨Know Your Stuff

Make sure you brush up on your knowledge of clinical regulatory documents, especially the ones mentioned in the job description like Clinical Study Protocols and Safety summaries. Being able to discuss these confidently will show that you're not just a writer, but an expert in the field.

✨Showcase Your Leadership Skills

Since this role involves leading projects and managing teams, be prepared to share examples of how you've successfully led writing projects in the past. Highlight your experience in steering discussions and driving consensus among stakeholders.

✨Be Ready to Collaborate

This position requires a lot of teamwork, so think about how you can demonstrate your collaborative spirit. Prepare anecdotes that showcase your ability to work with diverse teams and adapt to different environments, as well as how you’ve facilitated decision-making processes.

✨Ask Insightful Questions

At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current projects or how they envision the integration of new team members. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.

Principal Medical Writer
Fortrea
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  • Principal Medical Writer

    Full-Time
    48000 - 72000 £ / year (est.)
  • F

    Fortrea

    50-100
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