Medical Writing Manager

Hours: Full-time, 35 hours per week (requests for compressed hours or flexible working would be considered)., We have an exciting new opportunity for a Medical Writing Manager to lead and develop the medical writing function in the Centre for Drug Development (CDD). In this role you will provide broad medical writing expertise and ensure the timely production of regulatory compliant Clinical Study Reports, Investigator Brochures, and other clinical/scientific reports. In addition, you will drive innovation within the team, looking for opportunities to adopt new solutions and risk-based approaches to improve efficiencies. About the team The Cancer Research UK Centre for Drug Development (CDD) is the world's only charity-funded drug development organisation. 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?

• 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 to support strategies for medical writing deliverables across the portfolio, developing processes for complex, high-priority and international clinical trials, and providing input into development and review of other key documents such as protocols, statistical analysis plans or reporting analysis plans and publications.
• Line manage Medical Writing team members to ensure continued development, performance management and appropriate resourcing across all CDD trials according to individual team members' expertise and professional development.
• Provide specialist medical writing skills within the CDD, including writing, editing, reviewing and quality control (QC), to ensure production of Clinical Study Reports, Investigator Brochures (IBs) and summary results.
• Maintain oversight of all IB Packages in use in CDD-sponsored trials, ensuring timely generation to meet agreed goals and document updates in line with current clinical trial regulations.
• 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 that support Medical Writing (e.g. project management, document management, proofreading, Artificial Intelligence [AI]) and ensure regulatory document templates, Medical Writing SOPs and Guidance Documents are produced and maintained to ensure consistency in format and best practice in accordance with appropriate regulatory requirements.
• Select, assess and oversee consultant resource responsible for medical writing tasks to ensure quality and timeliness of outsourced activities.
  
  Educated to a minimum of Bachelor's degree level in a life science or medical discipline or related field.
• 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 able to build good working relationships with key functions in CDD to ensure timely delivery of data and documents. Able to build good relationships with stakeholders external to CDD.
• 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.
Desirable
• Higher degree (Masters or PhD).
• Experience in early phase clinical development.
• Oncology experience.
• Line management experience.
• Use of AI to generate document drafts.
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.