Principal Regulatory Medical Writer

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

Principal Regulatory Medical Writer - Centre for Drug Development

Salary: £50,000 - £58,000 pa + benefits

Contract type/ hours: Permanent/ full time 35 hours (flexible working requests considered)

Location: Stratford, London (High flex - we'd expect you to be in the office 1 or 2 days a week) or Home-based UK.

Application Deadline: Wednesday 1st May at 23.55. 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 are professionals with purpose, beating cancer every day. But we need to go much further and much faster. That's why we we're looking for someone talented, someone innovative and ambitious, someone like you.

About the team

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.

What will I be doing?

You'll provide medical writing expertise for the production of Clinical Study Reports (CSRs), Investigator's Brochures (IBs) and other clinical/scientific reports within the Cancer Research UK CDD. You'll provide specialist guidance and advice to others and promote best practice in medical writing, including identifying improvements and ensuring consistency. You'll also deputise for the Medical Writing Manager when required.

Key duties include to:

• Be a subject matter expert in Medical Writing activities, responsible for Medical Writer training and process improvements.
• Act as a mentor and train new starters and more junior Medical Writing roles and key groups in CDD as required, sharing knowledge and expertise to benefit others.
• Deputise for the Medical Writing Manager on delegated tasks and represent the Medical Writing group on cross-functional working groups.
• Provide specialist medical writing skills within CDD, including writing, editing, reviewing and quality control, to ensure timely production of CSRs and IBs within applicable regulatory timeframes.
• Manage the preparation, update and tracking of CSRs, clinical trial summary results and IB Packages in use in CDD‑sponsored trials in line with current regulations, and compile compliance metrics.
• Proactively contribute to the continuous review and improvement of document writing processes in CDD, to ensure consistency and best practice.
• 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 and to 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.

What skills are we looking for?

Essential

• Science graduate (Medical/Biomedical Sciences/Pharmaceutical/Pharmacy).
• Extensive regulatory writing experience with clinical trial documents including CSRs and IBs. Would ideally also include experience working with Protocols, Development Safety Update Reports (DSURs).
• Ability to produce high quality, scientifically/medically accurate reports.
• Experience reviewing and quality checking the work of other Medical Writers to ensure they meet the project brief/specification and are scientifically and technically accurate.
• Excellent proofreading skills and attention to detail.
• Organisational and communication skills.
• Negotiation and influencing skills.
• Excellent written and spoken English.

Desirable

• Medical/Medical Sciences background or experience.
• Higher degree (Masters or PhD).
• Experience in early phase clinical development.
• Oncology experience.
• Project management experience.

What will I gain?

Each and every one of our employees contributes to our progress and is supporting our work to beat cancer. We think that's impressive.

In return, we make sure you are supported by a generous benefits package, a wide range of career and personal development opportunities and high-quality tools, policies and processes to enable you to do your job well.

Our benefits package includes a substantial retirement plan, a generous and flexible leave allowance, discounts on anything from travel to technology, gym membership, and much more.

We review pay annually and aim to recognise individual performance and achievements.

We don't forget people have lives outside of work too and so we actively encourage a flexible working culture.

Our work - from funding cutting-edge research to developing public policy - will change the world. It's exciting to be part of our team.

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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