At a Glance
- Tasks: Lead the development of complex clinical regulatory documents for life-changing treatments.
- Company: Join Fortrea, a leader in the pharmaceutical industry with a mission to accelerate patient care.
- Benefits: Flexible remote work, comprehensive training, and opportunities for career growth.
- Other info: Collaborate with diverse teams across Europe, Americas, and Asia-Pacific.
- Why this job: Make a real impact on global health by shaping critical regulatory documents.
- Qualifications: Advanced degree in life sciences and 4+ years of regulatory medical writing experience.
The predicted salary is between 60000 - 80000 £ per year.
Sponsor-dedicated. Full time. Remote in the UK, Spain, South Africa, Greece, Portugal or Hungary. 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 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
- Imbedded 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.
- You will own the end-to-end medical writing process, from initial planning and cross-functional coordination through drafting, review, and final delivery, ensuring alignment with project strategy, stakeholder expectations, and agreed timelines.
- Your contribution will be essential authoring most study-level documents, for example: Protocols and protocol outlines, Subject Information / ICF, Lay summaries of clinical trial results, IBs, Regulatory briefing packages, responses.
- With minimal supervision, you will lead Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward.
- Conduct communication strategy meetings and facilitate comment resolution meetings, to consolidate contributions from experts and to manage conflicting comments early, ensuring smooth 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).
- 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. This means independent authoring, proactively collaborating with stakeholders to author content, drive discussions, and manage the authoring/review process.
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. Where do you see yourself?
Senior Regulatory Medical Writer in Leeds employer: Fortrea
At Fortrea, we are committed to fostering a dynamic and inclusive work environment that empowers our employees to excel in their careers. As a Senior Regulatory Medical Writer, you will enjoy the flexibility of remote work across various countries while collaborating with leading pharma experts on impactful projects. We prioritise your professional growth through comprehensive training and support, ensuring that your contributions lead to life-changing treatments for patients worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Medical Writer in Leeds
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Fortrea. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Fortrea.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Fortrea. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Fortrea is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Regulatory Medical Writer in Leeds
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Fortrea!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Fortrea that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Fortrea!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Fortrea, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Fortrea
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Fortrea that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Fortrea’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
