At a Glance
- Tasks: Lead the creation of regulatory documents for oncology programmes and manage timelines with stakeholders.
- Company: Dynamic international clinical research organisation with a collaborative culture.
- Benefits: Fully remote work, competitive salary, and opportunities for professional growth.
- Other info: Join a growing team and enjoy a visible role in regulatory activities.
- Why this job: Make a real impact in oncology while working closely with sponsors and medical teams.
- Qualifications: 5+ years in regulatory writing, especially in oncology, with strong communication skills.
The predicted salary is between 60000 - 80000 € per year.
An international clinical research organisation is looking to appoint a Senior Regulatory Writer to join its growing regulatory writing team. This role would suit an experienced regulatory writing professional who enjoys working across complex clinical development programmes and wants to play a visible role supporting sponsor-facing regulatory activities within a collaborative CRO environment.
The team is looking for someone who is confident managing regulatory documentation independently, comfortable coordinating across multiple stakeholders and able to contribute strategically across the wider submission process.
The opportunity
You’ll take ownership of a broad range of regulatory and clinical documents across oncology programmes, supporting studies throughout different stages of development and submission activity. Alongside document preparation, you’ll work closely with sponsors, medical teams and operational colleagues to coordinate timelines, manage review cycles and ensure documentation is aligned with regulatory expectations and project objectives.
The role offers strong exposure across cross-functional teams and would suit someone who enjoys balancing scientific accuracy, organisation and stakeholder management within a fast-moving environment.
Experience they’re hoping to see
- 5+ years’ experience within a CRO, biotech or pharmaceutical environment
- Strong background in regulatory writing within oncology
- Experience leading the preparation of regulatory documentation including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, IND applications and DSURs
- Familiarity with Fast Track Applications and accelerated submission pathways
- Experience coordinating sponsor reviews, timelines and document workflows
- Understanding of eCTD structures and regulatory submission requirements
- Ability to manage multiple projects simultaneously and work independently
- Strong written communication and stakeholder management skills
- A highly organised and detail-focused approach
What makes this opportunity interesting
- Broad involvement across oncology-focused regulatory programmes
- Client-facing exposure with direct sponsor interaction
- Opportunity to contribute across the full regulatory documentation lifecycle
- Visible role within a growing regulatory writing group
- Fully remote working available across the UK
Apply now. For more information, please contact Nicky Stunt, Principal Healthcare Communications Recruiter.
Senior Regulatory Medical Writer in Leicester employer: RBW Consulting
Join a leading international clinical research organisation that values collaboration and innovation in the regulatory writing field. With a strong focus on oncology programmes, this role offers the chance to work closely with sponsors and cross-functional teams, ensuring your contributions are impactful and recognised. Enjoy the flexibility of fully remote working across the UK, alongside opportunities for professional growth and development in a supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Medical Writer in Leicester
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research and regulatory writing fields. Attend industry events or webinars, and don’t be shy about introducing yourself to potential employers. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of oncology and regulatory processes. We recommend creating a list of common interview questions and practising your responses. Show them you’re not just a writer, but a strategic thinker who can manage complex projects with ease.
✨Tip Number 3
Don’t forget to showcase your experience with regulatory documentation! Bring examples of your work to interviews, and be ready to discuss how you’ve successfully managed timelines and stakeholder communications. We want to see that you can handle the pressure and deliver results.
✨Tip Number 4
Apply through our website for the best chance at landing that Senior Regulatory Medical Writer role! We’re always on the lookout for talented individuals who fit the bill, so make sure your application stands out. Let’s get you into that dream job together!
We think you need these skills to ace Senior Regulatory Medical Writer in Leicester
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in regulatory writing, especially in oncology. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory writing and how you can contribute to our team. We love seeing personality, so let your enthusiasm for the role come through.
Showcase Your Stakeholder Management Skills:Since this role involves coordinating with multiple stakeholders, make sure to highlight any experience you have in managing reviews and timelines. We want to know how you’ve successfully navigated complex projects in the past!
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. Plus, it’s super easy – just follow the prompts!
How to prepare for a job interview at RBW Consulting
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory writing, especially in oncology. Familiarise yourself with key documents like Clinical Study Protocols and IND applications. Being able to discuss these confidently will show that you’re the right fit for the role.
✨Showcase Your Project Management Skills
Prepare examples of how you've managed multiple projects and coordinated with various stakeholders in the past. Highlight your ability to keep timelines on track and ensure smooth review cycles. This will demonstrate your organisational skills and ability to work independently.
✨Engage with the Interviewers
Don’t just answer questions; engage with your interviewers. Ask them about their current projects or challenges they face in regulatory writing. This shows your interest in the role and helps you understand the team dynamics better.
✨Be Ready for Scenario Questions
Expect scenario-based questions where you might need to explain how you would handle specific regulatory challenges. Think through potential situations beforehand and prepare your responses. This will help you showcase your strategic thinking and problem-solving abilities.
