Principal Regulatory Medical Writer

We have an exciting opportunity for two Principal Regulatory Medical Writers to join Cancer Research UK's Centre for Drug Development (CDD), with one permanent position and one 12-month fixed-term contract available. In this role, you'll provide expert medical writing support across a range of key regulatory and scientific documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and other clinical and scientific reports. You'll play a key role in ensuring the delivery of high-quality, compliant documentation that supports our clinical development programmes. As a senior member of the team, you'll provide specialist advice and guidance on medical writing best practice, drive consistency across documents, and identify opportunities to improve processes and ways of working. You'll also support the wider team by deputising for the Medical Writing Manager when required. About the team The Cancer Research UK Centre for Drug Development (CDD) is the world's only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in. What will you be doing? Key duties include:

• Be a subject matter expert in Medical Writing activities, responsible for Medical Writer training and process improvements.
• Act as a mentor and train new starters and more junior Medical Writing roles and key groups in CDD as required, sharing knowledge and expertise to benefit others.
• Deputise for the Medical Writing Manager on delegated tasks and represent the Medical Writing group on cross-functional working groups.
• Provide specialist medical writing skills within CDD, including writing, editing, reviewing and quality control, to ensure timely production of CSRs and IBs within applicable regulatory timeframes.
• Manage the preparation, update and tracking of CSRs, clinical trial summary results and IB Packages in use in CDD-sponsored trials in line with current regulations, and compile compliance metrics.
• Proactively contribute to the continuous review and improvement of document writing processes in CDD, to ensure consistency and best practice.
• Produce and maintain appropriate regulatory document templates, SOPs and guidance documents.
• Develop and maintain an awareness of CDD clinical trials and key projects. Build good working relationships with key functions in CDD to ensure timely delivery of data and documents and to review third-party documents to assess the need for IB supplements.
• Assist with recruitment and may have line management responsibilities for up to 2 members of the Medical Writing team.
  
  Science graduate (Medical/Biomedical Sciences/Pharmaceutical/Pharmacy).
• Extensive regulatory writing experience with clinical trial documents including CSRs and IBs. Would ideally also include experience working with Protocols, Development Safety Update Reports (DSURs).
• Ability to produce high quality, scientifically/medically accurate reports.
• Experience reviewing and quality checking the work of other Medical Writers to ensure they meet the project brief/specification and are scientifically and technically accurate.
• Excellent proofreading skills and attention to detail.
• Organisational and communication skills.
• Negotiation and influencing skills.
• Excellent written and spoken English.
Desirable
• Medical/Medical Sciences background or experience.
• Higher degree (Masters or PhD).
• Experience in early phase clinical development.
• Oncology experience.
• Project management experience.
Our organisation values are designed to guide all that we do. Bold: Act with ambition, courage and determination Credible: Act with rigour and professionalism, We're looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer.