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About the Role
Cancer Research UK is seeking two Principal Regulatory Medical Writers to join their Centre for Drug Development (CDD). This role involves providing expert medical writing support for key regulatory and scientific documents, ensuring the delivery of high-quality, compliant documentation for clinical development programs. As a senior team member, you will offer specialist advice, drive document consistency, and identify process improvements. You will also support the Medical Writing Manager by deputizing when necessary.
Responsibilities
- Act as a subject matter expert in Medical Writing activities, responsible for Medical Writer training and process improvements.
- Mentor and train new starters, junior Medical Writing roles, and key groups in CDD.
- Deputize for the Medical Writing Manager on delegated tasks and represent the Medical Writing group on cross-functional working groups.
- Provide specialist medical writing skills including writing, editing, reviewing, and quality control for timely production of CSRs and IBs within regulatory timeframes.
- Manage the preparation, update, and tracking of CSRs, clinical trial summary results, and IB Packages in line with current regulations, and compile compliance metrics.
- Proactively contribute to the continuous review and improvement of document writing processes in CDD.
- 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.
- 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.
Requirements
- Science graduate (Medical/Biomedical Sciences/Pharmaceutical/Pharmacy).
- Extensive regulatory writing experience with clinical trial documents including CSRs and IBs.
- Experience working with Protocols and Development Safety Update Reports (DSURs) is ideal.
- Ability to produce high quality, scientifically/medically accurate reports.
- Experience reviewing and quality checking the work of other Medical Writers.
- Excellent proofreading skills and attention to detail.
- Organisational and communication skills.
- Negotiation and influencing skills.
- Excellent written and spoken English.
Skills
- Medical Writing
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- Protocols
- Development Safety Update Reports (DSURs)
- Editing
- Reviewing
- Quality Control
- Proofreading
- Attention to detail
- Organisational skills
- Communication skills
- Negotiation skills
- Influencing skills
- Early phase clinical development
- Oncology
- Project management
Location
- Stratford, London
- Homebased
Work Type
- Permanent Contract
- 12 month Fixed-term Contract
- Full-time
- Flexible working
Experience Level
- Principal
- Senior
Education Level
- Science graduate (Medical/Biomedical Sciences/Pharmaceutical/Pharmacy)
- Higher degree (Masters or PhD) - Desirable
Salary/Compensations
- £50,000-£58,000
Benefits
- Generous benefits package
- Wide range of career and personal development opportunities
- High-quality tools
- Policies and processes to improve work-life balance
About the Company
- Cancer Research UK exists to beat cancer.
- The Cancer Research UK Centre for Drug Development (CDD) is the world's only charity-funded drug development facility.
- Pioneering research driven 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.
- The organisation values are: Bold, Credible, Human, Together.
Equal Opportunity
- We operate an anonymised shortlisting process in our commitment to equality, diversity and inclusion.
- We 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.