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- Tasks: Lead medical writing for Oncology, overseeing teams and ensuring compliance in clinical documents.
- Company: Global biopharmaceutical leader focused on innovation and quality.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in oncology while shaping regulatory strategies at a global level.
- Qualifications: Proven leadership in medical writing with expertise in clinical development and regulatory submissions.
- Other info: Join a forward-thinking team that values transformation and scientific integrity.
The predicted salary is between 43200 - 72000 £ per year.
Your new company
Are you a seasoned Medical Writer with expert experience of writing Clinical and Regulatory documents?
Our client, a global biopharmaceutical powerhouse, is seeking a Consultant Medical Writer to lead strategic and operational excellence across their Oncology portfolio.This is a high-impact, global role offering the chance to influence regulatory strategy at the highest level and join a forward-thinking organisation that values transformation, quality, and scientific integrity.
Remote
OUTSIDE IR35
Your new role
As Director, Medical Writing, you\’ll be the go-to expert for all medical writing activities within the Oncology Therapeutic Area.
You\’ll:
Oversee a team of Senior Medical Writers and Managers across global hubs.
Develop and execute TA-specific medical writing roadmaps aligned with R&D priorities.
Oversee and provide input on all documents for clinical development from FIH through Phase 3 and Regulatory submissions including regulatory interactions with agencies (e.g., pre-IND, End of Phase 2, End of Phase 3, Type C meetings).
Be highly organised, proactive, respects metrics-driven timelines and accountability for quality.
Ensure consistency and compliance across the therapeutic area documents (protocols through marketing applications).
Drive regulatory storytelling and key message generation for critical submissions.
Ensure quality, consistency, and compliance across all deliverables.
Manage outsourced writing models and vendor relationships.
What you\’ll need to succeed
Proven experience in medical writing leadership within oncology or a related TA.
Expert experience of writing documents for clinical development from FIH through Phase 3 and Regulatory submissions including regulatory interactions with agencies (e.g., pre-IND, End of Phase 2, End of Phase 3, Type C meetings).
Deep understanding of global regulatory requirements and submission strategy.
Strong background in clinical development and cross-functional collaboration.
Exceptional communication, negotiation, and strategic thinking skills.
A passion for innovation, including AI-assisted writing and process transformation.
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you\’re interested in this role, click \’apply now\’ to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292
Consultant Medical Writer - Regulatory and Clinical Documents employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Consultant Medical Writer - Regulatory and Clinical Documents
✨Tip Number 1
Network like a pro! Reach out to your connections in the biopharmaceutical industry, especially those in oncology. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory submissions and clinical development. We recommend practising common interview questions and scenarios related to medical writing to showcase your expertise.
✨Tip Number 3
Showcase your passion for innovation! If you’ve used AI-assisted writing tools or have ideas for process transformation, make sure to highlight these during interviews. It’ll set you apart from other candidates.
✨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 Consultant Medical Writer - Regulatory and Clinical Documents
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in medical writing, especially in oncology. We want to see how your skills align with the role, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your background makes you the perfect fit. We love seeing genuine enthusiasm for the position.
Showcase Your Regulatory Knowledge: Since this role involves a lot of regulatory work, make sure to emphasise your understanding of global regulatory requirements. We’re looking for someone who can navigate these complexities with ease!
Apply Through Our Website: Don’t forget to apply 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 to do!
How to prepare for a job interview at Hays
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical and regulatory documents, especially in the oncology field. Familiarise yourself with the latest guidelines and requirements, as well as any recent developments in the biopharmaceutical industry. This will show that you're not just a writer, but a knowledgeable expert.
✨Showcase Your Leadership Skills
Since this role involves overseeing a team, be prepared to discuss your leadership experience. Think of specific examples where you've successfully managed projects or guided teams through complex writing tasks. Highlight your ability to drive quality and consistency across documents.
✨Prepare for Regulatory Discussions
Expect questions about your experience with regulatory submissions and interactions with agencies. Be ready to share your insights on how to navigate these processes effectively. Discuss any past experiences with pre-IND meetings or End of Phase submissions to demonstrate your expertise.
✨Emphasise Innovation and Collaboration
This company values transformation and innovation, so be sure to mention any experience you have with AI-assisted writing or process improvements. Also, highlight your ability to collaborate cross-functionally, as this is crucial in a global role. Share examples of how you've worked with different teams to achieve common goals.