Regulatory writing submission graduate

Job Description

Location: White City, London

Pay Rate: £31,050

12 Month Fixed Term Contract

Hybrid Working Scheme - 2/3 days on site per week


About the Role

We’re looking for a detail-oriented and scientifically driven Regulatory Writing Submissions Graduate to join our clients Regulatory Writing & Submissions (RWS) team. In this role, you’ll contribute to the creation of high-quality clinical and safety documentation that supports global drug development and regulatory submissions.


Key Responsibilities

* Draft and edit clinical and safety documents under guidance, including:
* Clinical Study Protocols (CSPs) and amendments
* Non-registration Clinical Study Reports (CSRs)
* Development Safety Update Reports (DSURs)
* Clinical Trial Registration Documents
* Represent RWS in Clinical Trial Teams (CTTs)
* Support planning of data analyses and presentation for CSRs
* Ensure documentation complies with internal standards and regulatory guidelines
* Liaise with publishing teams to ensure timely delivery of final documents
* Contribute to process improvements within RWS
* Maintain compliance with audits, SOPs, and training requirements


What Success Looks Like