4,000 professionals, 0 days wasted, 1 incredible purpose. Together we are beating cancer.

Medical Writing Manager

Salary: £67,000 - £72,000 pa depending on experience

Reports to: Head of Quality, Regulatory and Pharmacovigilance

Department: Research & Innovation

Contract: Permanent

Hours: Full time 35 hours per week (requests for compressed working would be considered)

Location: Home based (UK)

Closing date: Sunday 17th August at 23.59.

This vacancy may close earlier if a high number of applications are received or once a suitable candidate is found, so please do not delay submitting your application to avoid any disappointment.

At Cancer Research UK, we exist to beat cancer.

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 I 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.

What skills are we looking for?

• 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.

Our organisation values are designed to guide all that we do.

Bold: Act with ambition, courage and determination

Credible: Act with rigour and professionalism

Human: Act to have a positive impact on people

Together: Act inclusively and collaboratively

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.

What will I gain?

We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities and high-quality tools. Our policies and processes enable you to improve your work-life balance, take positive steps in your career and achieve your personal wellbeing goals.

You can explore our benefits by visiting our careers web page.

How do I apply?

We operate an anonymised shortlisting process in our commitment to equality, diversity, and inclusion. CVs are required for all applications; but we won't be able to view them until we invite you for an interview. Instead, we ask you to complete the work history section of the online application form for us to be able to assess you quickly, fairly, and objectively.

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Please note: You must be eligible to work in the UK to apply for this vacancy. Cancer Research UK is not able to offer visa sponsorship.