At a Glance
- Tasks: Lead the development of complex regulatory documents for life-changing treatments.
- Company: Fortrea, a leader in pharmaceutical innovation with a focus on collaboration.
- Benefits: Remote work, career growth opportunities, and a supportive environment.
- Other info: Join a diverse team and shape your unique career path.
- Why this job: Make a real impact in healthcare by translating science into clear regulatory content.
- Qualifications: 3 years of regulatory writing experience and strong communication skills.
The predicted salary is between 40500 - 49500 £ per year.
Full time. Remote in the UK, South Africa, Greece, Portugal. Ready to take ownership of complex regulatory documents while working directly with some of the world's leading pharmaceutical companies? At Fortrea, we help bring life-changing treatments to patients faster. To do that, we need experienced Medical Writers who can lead document development, align stakeholders, and translate complex science into clear, high-quality regulatory content. Join Fortrea. Your work matters.
WHAT YOU’LL DO
As a Regulatory Medical Writer II, you'll take ownership of high-complexity Phase II-IV clinical regulatory documents that support critical development programmes. You'll manage the full document lifecycle, from planning and stakeholder engagement through drafting, review and final delivery. Your work will include:
- Authoring protocols, protocol outlines, ICFs, investigator brochures, lay summaries and regulatory briefing packages.
- Leading document planning, review and approval activities across geographically distributed teams.
- Interpreting efficacy, safety, exposure and endpoint data to develop clear scientific content.
- Building alignment between cross-functional stakeholders and facilitating efficient document development.
- Managing timelines, resolving comments and ensuring projects move forward as planned.
WHO YOU’LL WORK WITH
You’ll collaborate closely with experts across:
- Biostatistics
- Data Management
- Programming
- Clinical Leadership
- Project Physicians
- Global Medical Writing teams across Europe, the Americas and Asia-Pacific
You’ll become a key partner in the document development process, helping teams work together to deliver high-quality regulatory submissions.
WHAT YOU BRING
- 3 years of regulatory medical writing experience
- A minimum of 1 year leading medical writing projects
- Experience independently authoring and managing clinical regulatory documents
- Knowledge of ICH guidelines and regulatory requirements
- Strong scientific communication and stakeholder management skills
- Degree in Life Sciences. PhD preferred
WHY JOINING FORTREA?
This is an opportunity to work in a sponsor-focused environment where Medical Writers play a visible role in decision-making and document strategy. You'll gain exposure to global development programmes, collaborate with experienced stakeholders across multiple functions, and continue developing your project leadership capabilities.
A Uniquely Diverse Career
Whether you want to deepen your scientific expertise or progress towards senior and leadership roles, Fortrea provides the training, support, and professional network to help you grow. Your career path is yours to shape. Where could it take you?
Regulatory Medical Writer II in Maidenhead employer: Fortrea
Fortrea is an exceptional employer that offers a rewarding and meaningful work environment, particularly for Senior Technical Designers. With a strong support network, flexible working solutions, and a commitment to employee growth, you will thrive in a collaborative workspace that values diversity and inclusion. Enjoy competitive compensation packages and the opportunity to make a significant global impact while maintaining a genuine work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Medical Writer II in Maidenhead
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Fortrea. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Fortrea!
We think you need these skills to ace Regulatory Medical Writer II in Maidenhead
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Fortrea that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Fortrea.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Fortrea does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Fortrea
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Fortrea. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Fortrea's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Fortrea. This shows your passion for the industry!
