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- 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, career development opportunities, and a supportive team environment.
- Why this job: Shape your career in medical writing while making a real impact in healthcare.
- Qualifications: Advanced degree and extensive experience in eCTD submission writing required.
- Other info: Join a diverse team where your career path is yours to shape.
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. But we can’t do it alone. 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
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.
- Writer, advisor, and coordinator for the 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. 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.
Principal Medical Writer in London employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal 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. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios specific to medical writing. We recommend doing mock interviews with friends or mentors to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your expertise! Bring samples of your previous work to interviews, especially those related to clinical regulatory documents. This will demonstrate your skills and give potential employers a taste of what you can bring to their team.
✨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 their job search!
We think you need these skills to ace Principal 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 Principal Medical Writer role. 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 at Fortrea. 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 managed stakeholder relationships in previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. This way, we can ensure your application gets the attention it deserves and you can easily keep track of your application status!
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 Safety summaries. Brush up on eCTD formats and be ready to discuss your past experiences with these documents.
✨Showcase Your Project Management Skills
This role requires strong project management abilities. Prepare examples of how you've successfully managed writing projects in the past. Highlight your experience in coordinating with stakeholders and driving consensus, as this will demonstrate your capability to lead discussions and facilitate decision-making.
✨Emphasise Collaboration and Teamwork
Integration within the partner's team is crucial for this position. Be ready to talk about times when you’ve worked closely with diverse teams. Share specific instances where your collaboration led to successful outcomes, showcasing your ability to adapt and engage with various stakeholders.
✨Prepare Questions That Show Your Passion
At Fortrea, they value individuals who are passionate about their work. Prepare thoughtful questions that reflect your enthusiasm for medical writing and your interest in their mission. This not only shows your commitment but also helps you gauge if the company aligns with your career aspirations.
