Regulatory Medical Writer

Hyper intelligence. Curious mindsets. Accelerated progress.   

Regulatory Medical Writer

£36,000 - £44,000 plus benefits

Reports to: Medical Writing Manager

Directorate: Research & Innovation

Contract: Permanent

Hours: Full time 35 hours per week ( flexible working requests considered, minimum 32 hours per week)

Location: Homebased or Stratford , London (1-2 days a week in the office)

Closing date: 08 December 2024 23:55

This vacancy may close earlier if a high volume of applications is received or once a suitable candidate is found; therefore, we strongly recommend that you apply early to avoid disappointment. Please let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply. Please contact recruitment@cancer.org.uk or 020 3469 8400 as soon as possible.

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: Pre-prepared task followed by competency based interview  

Interview date: W/C 13 Jan 2025 (Shortlisting will take place in December)

At Cancer Research UK, we exist to beat cancer.

Cancer Research UK are looking for a Regulatory Medical Writer. 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.

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 you 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 or equivalent experience of scientific writing.

• 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 s