Regulatory Medical Writing jobs

Reporting to the Research Management and Governance Manager, a talented and experienced individual is sought to advice researchers on research amendments. Key member of Research Management and Governance team of JRO, the postholder will review and approve research amendments for UCL and UCLH sponsored studies as well as amendments received for studies hosted by UCLH. It is a cross cutting role between sponsorship and hosted amendment reviews. If offers excellent all round developmental opportunity.

A self-starter, you will have excellent organisational skills with a good understanding of research management and governance. You will also be expected to have knowledge of access, arrange and confirm ( AAC) site level review. You should be pragmatic and have proven ability to communicate effectively with senior clinicians, academic staff and other health service professionals to help deliver this challenging agenda within a dynamic multi-disciplinary environment.

The post holder will be required to maintain a good working relationship and a high level of customer service with R&D and BRC teams as well as external stakeholders.

This is an exciting role to support research at UCLH within a dynamic RM&G team what values team work and supporting each other.

• Manage end‑to‑end processing of amendment submissions for UCL/UCLH‑sponsored (non‑MHRA regulated) studies and all UCLH‑hosted studies, ensuring timely review, approval and communication to sites.
• Ensure timely and accurate handover of amendments to other JRO teams in accordance with agreed processes.
• Maintain accurate amendment logs and trackers in EDGE ( and/or any applicable system) and, where required; file and retrieve core documentation when necessary.
• Monitor performance against amendment to turnaround targets; provide clear, regular updates to investigators and stakeholders.
• Produce concise amendment activity reports and metrics; escalate risks or delays to senior JRO staff as appropriate.
• Provide guidance to study teams on amendment categories, required documentation and local capacity/capability implications. Engage in outreach activities, including presentation of amendments
• Undertake general administrative tasks to support JRO operations as allocated by senior staff.

University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.

We provide first-class acute and specialist services across eight sites:

• University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
• National Hospital for Neurology and Neurosurgery
• Royal National ENT and Eastman Dental Hospitals
• University College Hospital Grafton Way Building
• Royal London Hospital for Integrated Medicine
• University College Hospital Macmillan Cancer Centre
• The Hospital for Tropical Diseases
• University College Hospital at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women’s health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.

We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

Come and be a part of the best NHS trust in England to work for, according to our staff*

• UCLH top trust to work at in England - In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England – for the third year in a row.

UCLH recognises the benefits of flexible working for staff – To find out more, visit: Flexible working .

To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?