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Regulatory writing submission graduate

SRG
Writer
Posted: 14 September
Offer 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 Timely delivery of high-quality documents that meet internal and external standards Completion of a meaningful volume of work annually, aligned with performance metrics Qualifications & Experience Education: Minimum: University degree in life sciences or equivalent Preferred: Advanced degree in life sciences or healthcare Experience: Some experience in medical writing or relevant pharmaceutical industry roles Solid understanding of global regulatory processes and documentation Familiarity with biostatistics principles Strong problem-solving and project management skills Excellent written and verbal communication skills Ability to work in a matrixed, cross-cultural environment Why Join Us? This is a fantastic opportunity to grow your career in regulatory writing within a collaborative and globally connected team. You’ll be at the forefront of clinical documentation, helping bring innovative therapies to patients worldwide.

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