Location:
[Insert Location]
Department:
Regulatory Writing & Submissions (RWS)
Pay Rate:
31,050
About the Role
We're looking for a detail-oriented and scientifically driven
Associate Regulatory Writer
to join our 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.