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About the Role

Lead and develop the medical writing function within the Centre for Drug Development (CDD), providing broad medical writing expertise to ensure the timely production of regulatory-compliant Clinical Study Reports, Investigator Brochures, and other clinical/scientific reports. Drive innovation by adopting new solutions and risk-based approaches to improve efficiencies.

Responsibilities

• Manage the medical writing function in CDD to achieve best practice and deliver agreed CDD documents to a high quality within applicable regulatory guidelines and timeframes.
• Provide specialist support to project teams, including advice on strategies for medical writing deliverables, developing processes for complex trials, and input into development and review of other key documents.
• Line manage Medical Writing team members to ensure continued development, performance management, and appropriate resourcing.
• Provide specialist medical writing skills, including writing, editing, reviewing, and quality control (QC), for Clinical Study Reports, Investigator Brochures (IBs), and summary results.
• Maintain oversight of all IB Packages in use in CDD-sponsored trials, ensuring timely generation and updates.
• Work with Project Teams to review third-party IBs and assess the need for CRUK IB supplements.
• Maintain oversight of all results reporting across CDD-sponsored trials, including CSRs, CSR addenda, summary results for disclosure on public trial registries, and lay summaries.
• Drive the continuous review of Medical Writing processes and external systems, ensuring regulatory document templates, SOPs, and Guidance Documents are produced and maintained.
• Select, assess, and oversee consultant resource responsible for medical writing tasks to ensure quality and timeliness of outsourced activities.

Requirements

• Must be eligible to work in the UK.
• Extensive experience in Medical Writing, writing regulatory reports and clinical/scientific documents in a medical/pharmaceutical field.
• Thorough knowledge of regulatory requirements for relevant clinical trial documents, including IBs, CSRs, and clinical trial summary results.
• Strong interpersonal skills and ability to build good working relationships with key functions in CDD and external stakeholders.
• Excellent written and verbal English, proofreading skills, and attention to detail.
• Proven experience in training, mentoring, and/or line management in the field of Medical Writing.

Skills

• Medical Writing
• Regulatory reporting
• Clinical/scientific document writing
• Regulatory requirements for clinical trial documents
• Interpersonal skills
• Written and verbal English
• Proofreading
• Attention to detail
• Training
• Mentoring
• Line management

Location

• Stratford, London
• Homebased

Work Type

• Permanent
• Full-time
• High flex (1-2 days per week in office)
• Homebased on request
• Flexible working

Experience Level

• Managerial
• Extensive experience in Medical Writing

Education Level

• Bachelor’s degree in a life science or medical discipline or related field
• Higher degree (Masters or PhD) - Desirable

Salary/Compensations

• £70,000 - £77,000

Benefits

• Generous benefits package
• Wide range of career and personal development opportunities
• High-quality tools
• Work-life balance support
• Positive career steps
• Personal wellbeing goals

About the Company

• Cancer Research UK exists to beat cancer.
• The Centre for Drug Development (CDD) is the world's only charity-funded drug development organisation.
• Pioneering research driven by the goal to see scientific breakthroughs bring benefits to patients sooner.
• CDD sponsors early phase and precision medicine clinical trials in oncology agents.
• Broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules.
• Organisation values: Bold, Credible, Human, Together.

Equal Opportunity

• We operate an anonymised shortlisting process in our commitment to equality, diversity and inclusion.
• Actively encourage applications from people of all backgrounds and cultures, in particular those from ethnic minority backgrounds who are currently under-represented.
• We want to see every candidate performing at their best throughout the job application process, interview process and whilst at work. We therefore ask you to inform us of any concerns you have or any adjustments you might need to enable this to happen.
• Unfortunately, we are unable to recruit anyone below the age of 18, so that we can protect young people from health & safety and safeguarding risks.