At a Glance
- Tasks: Lead the creation of regulatory documents for oncology programmes and manage timelines with stakeholders.
- Company: Join a dynamic international clinical research organisation with a collaborative culture.
- Benefits: Fully remote work, competitive salary, and opportunities for professional growth.
- Other info: Enjoy a visible role in a growing team with diverse project involvement.
- 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 - 75000 € 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 Leeds 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 remotely across the UK, providing flexibility while engaging with cross-functional teams and sponsors. The company fosters a supportive work culture that encourages professional growth and development, making it an excellent employer for those seeking meaningful contributions in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Medical Writer in Leeds
✨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 programmes and regulatory documentation. We recommend practising common interview questions and even role-playing with a friend. The more confident you are, the better you’ll shine during those sponsor-facing discussions!
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you’ve managed multiple projects and coordinated timelines effectively. We want to see how you balance scientific accuracy with stakeholder management – it’s all about demonstrating your ability to juggle responsibilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for talented individuals who can contribute to our growing regulatory writing team. So, get your application in and let’s make it happen!
We think you need these skills to ace Senior Regulatory Medical Writer in Leeds
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. Be sure to mention any specific experiences that relate to managing documentation and coordinating with stakeholders.
Showcase Your Communication Skills:Since this role involves a lot of collaboration, make sure your application reflects your strong written communication skills. We love seeing examples of how you've effectively managed stakeholder relationships or coordinated timelines in past roles.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother process. It helps us keep track of applications and ensures you get all the latest updates about your application status!
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. Be ready to discuss your experience with Clinical Study Protocols and IND applications, as well as any familiarity with eCTD structures. This will show that you’re not just a writer, but someone who understands the intricacies of the regulatory landscape.
✨Showcase Your Project Management Skills
Since this role involves managing multiple projects and coordinating with various stakeholders, be prepared to share specific examples of how you've successfully juggled deadlines and document workflows in the past. Highlight your organisational skills and how you ensure everything aligns with regulatory expectations.
✨Engage with the Interviewers
Don’t just wait for questions; engage with the interviewers by asking insightful questions about their current projects or challenges they face in regulatory writing. This shows your interest in the role and helps you gauge if the company culture is a good fit for you.
✨Demonstrate Your Communication Skills
As a Senior Regulatory Medical Writer, strong written and verbal communication is key. During the interview, articulate your thoughts clearly and concisely. You might even want to prepare a brief summary of a complex project you’ve worked on to showcase your ability to communicate scientific information effectively.
