Regulatory Medical Writer

About

Cancer Research UK are looking for a Regulatory Medical Writer to support our platform trial, DETERMINE. This exciting role sits within the CRUK Centre for Drug Development where our goal is to bring much needed new treatments to people with cancer.

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.

As a Medical Writer you'll be providing broad medical writing expertise for the production of clinical study reports, investigator brochures and other clinical/scientific reports for CDD's early phase oncology trials. As well as acting as lead author on your assigned projects and performing quality control review of documents produced by other Medical Writers, you will be fully embedded within a multidisciplinary, cross functional project team along with other CDD departments. Collaboration is essential, as well as the ability to work strategically within an evolving environment.

Responsibilities

• Writing, editing, reviewing and quality control of documents for the timely production of clinical study reports and investigator brochures.
• Managing the preparation of clinical study reports by building consensus with the project teams on report requirements, responsibilities for delivery of data and production timelines, and participating in the preparation and review of summary clinical trial results and other disclosures as required.
• Managing the scheduling, preparation and updating of investigator brochure packages in use in CDD-sponsored trials, ensuring review at least annually in line with current regulations.
• Liaising with the project team to complete project-specific tasks including review of protocols, Trial Master Files, data (including expert reports), and analytical plans.

Qualifications

• Proven experience in medical / medical sciences writing including significant experience in regulatory medical writing or a mix of regulatory medical writing plus substantial relevant experience in clinical trials, pharmacovigilance or medical writing.
• Science graduate or equivalent experience of scientific writing.
• Good knowledge of regulatory requirements for clinical trial documents such as investigator brochures, clinical study reports and posting of clinical trial summary results.
• Excellent proofreading skills and attention to detail.
• Confident communication skills and able to foster strong working relationships both internally and externally.
• Project Management skills.
• Experience within early phase oncology trials is desirable but not essential.

Additional Information

• Contract: 24 months fixed term contract
• Hours: Full time 35 hours per week (flexible working requests considered, minimum 32 hours per week)
• Location: Stratford, London (1-2 days a week in the office). Home-based contracts available through flexible working policy.
• Occasional travel 4 to 6 times a year within London area; travel expenses not covered.
• Visa sponsorship not available; applicants must be eligible to work in the UK.

Benefits

• Flexible working hours
• Career and personal development opportunities
• Wellbeing support
• Generous benefits package
• High-quality tools

Organisation Values

• 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

Cancer Research UK is committed to equality, diversity and inclusion and encourages applications from all backgrounds.