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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 employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior 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 lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to regulatory medical writing. We recommend role-playing with a friend to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your expertise! Bring samples of your previous work to interviews, especially those that highlight your experience with CSRs and Protocols. This will demonstrate your skills and give you an edge.
✨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 Senior Medical Writer
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 previous projects.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for this position. Share your passion for medical writing and how your background aligns with our mission to deliver life-changing treatments.
Showcase Your Communication Skills: Since this role involves coordinating with various teams, demonstrate your excellent communication skills in your application. Mention any experiences where you successfully led discussions or resolved conflicts.
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 without any hiccups!
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 Investigator's Brochures and Clinical Study Reports. Make sure you understand the nuances of these documents and can discuss their structure and purpose confidently during the interview.
✨Showcase Your Project Leadership Skills
You'll need to lead kick-off strategy meetings and manage contributions from various teams. Prepare examples from your past experiences where you've successfully led projects, resolved conflicts, and driven consensus among stakeholders.
✨Demonstrate Your Communication Prowess
Effective communication is key in this role. Be ready to discuss how you've maintained alignment with sponsors and facilitated discussions among diverse teams. Highlight any strategies you've used to ensure clear and timely communication.
✨Be Ready for Technical Questions
Expect questions about interpreting raw study data and translating it into concise language. Brush up on your technical knowledge and be prepared to explain how you approach data interpretation and document development.
