Regulatory Medical Writer

Hyper intelligence. Curious mindsets. Accelerated progress.

Regulatory Medical Writer

£36,000 - £47,000 plus benefits

Reports to:
Medical Writing Manager or Principal Medical Writer

Directorate:
Research & Innovation

Contract:
x2 Contracts - 1x 15 months fixed term contract and 1x 2 years 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) *
We're happy to offer home-based contracts through our flexible working policy.

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

Recruitment process
: Competency based interview and Medical Writing task

At Cancer Research UK, we exist to beat cancer.

Cancer Research UK are looking for 2 Regulatory Medical Writers, a 15 month contract to support our portfolio while we scope and embed new technology and a 2-year contract to support our platform trial, DETERMINE. These exciting roles sit within the Cancer Research UK Centre for Drug Development (CDD) where our goal is to bring much needed new treatments to people with cancer.

The Cancer Research UK 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.

Unfortunately, this role is not suitable for anyone who only has experience in medical writing for pharmacovigilance or medical devices or anyone who only has medical writing experience within science comms. You must come with strong knowledge of regulatory requirements for clinical trial documents e.g. investigator brochures, clinical study reports and posting of clinical trial summary results. This is a great opportunity for a current Regulatory Medical Writer looking to move into a more purpose driven environment or to gain valuable experience withing phase 1 oncology trials. Or you could be a Medical Writing Associate ready to take that next step.

What will I be doing?

• 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.

What are we looking for?

• Proven experience in medical / medical sciences writing. This should include significant experience in regulatory medical writing or a mix of experience in regulatory medical writing plus substantial relevant experience in a related role in clinical trials, pharmacovigilance or medical writing.
• Science graduate.
• Good knowledge of regulatory requirements for clinical trial documents e.g. 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 (*Please do still apply even if you don't have this*)
• Experience within AI medical writing tools is beneficial.

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.

If you're interested in applying and excited about working with us but are unsure if you have the right skills and experience we'd still love to hear from you.

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 fairly and objectively.

For more information on this career opportunity please visit our website or contact us at

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Our vision is to create a charity where everyone feels like they belong, benefits from and participates in, the work we do. 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. Please contact or
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as soon as possible.

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.