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- Tasks: Lead the creation of complex clinical regulatory documents for a top global pharmaceutical client.
- Company: Join Fortrea, a mission-driven company focused on delivering life-changing treatments.
- Benefits: Enjoy remote work flexibility, 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 submissions and project leadership.
- Other info: Shape your unique career path with comprehensive training and support for future 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.
Responsibilities
- You will work sponsor dedicated, embedded on their team.
- 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
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
- 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 in Leeds employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal 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 open doors and give you insights that job descriptions just can't.
✨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, having tangible examples will set you apart.
✨Tip Number 3
Prepare for interviews by diving deep into the company’s projects and values. Tailor your responses to show how your experience aligns with their mission to deliver life-changing treatments faster.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who are proactive about joining our mission.
We think you need these skills to ace Principal Medical Writer in Leeds
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 had 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. Be sure to mention your experience with complex clinical regulatory documents and your ability to collaborate with diverse teams.
Showcase Your Expertise: In your application, don’t shy away from showcasing your expertise in writing clinical study protocols and reports. We want to see examples of how you've led document development and engaged with stakeholders in previous roles.
Apply Through Our Website: For the best chance of success, make sure to apply through our website. This way, we can easily track your application and ensure it reaches the right people. Plus, it shows you're serious about joining our team!
How to prepare for a job interview at Fortrea
✨Know Your Documents Inside Out
As a Principal Medical Writer, you'll be dealing with complex clinical regulatory documents. Make sure you’re familiar with the types of documents mentioned in the job description, like Clinical Study Protocols and Investigator Brochures. Brush up on eCTD formats and be ready to discuss your past experiences with these documents.
✨Showcase Your Leadership Skills
This role requires you to lead project teams and manage writing projects. Prepare examples from your previous roles where you successfully led a team or project. Highlight how you facilitated discussions and drove consensus among stakeholders, as this will demonstrate your ability to thrive in a collaborative environment.
✨Be Ready for Technical Questions
Expect questions that dive deep into your technical expertise, especially around efficacy and safety summaries. Review common challenges faced in medical writing and think about how you’ve overcome them. This will show that you not only have the knowledge but also the problem-solving skills needed for the role.
✨Demonstrate Adaptability
The job mentions the need for adaptability across environments and therapeutic areas. Be prepared to discuss times when you had to adjust your approach or learn something new quickly. This will illustrate your readiness to integrate into their team and take on augmented responsibilities.
