Regulatory Writer - Remote - Studentjob.co.uk
Regulatory Writer - Remote - Studentjob.co.uk
1 day ago Be among the first 25 applicants
We are currently partnering with a leading global medical communications agency to support their search for an experienced Regulatory Medical Writer. This is a fantastic opportunity to contribute to meaningful regulatory submissions across a variety of therapeutic areas, working with a highly collaborative and well-established team.
About the Role:
This position involves the development of high-quality, accurate, and compliant documentation to support global regulatory submissions. You will work closely with internal teams and external clients to ensure that deliverables meet both scientific and regulatory standards.
Key Responsibilities:
* Write and edit a variety of regulatory documents (e.g., clinical study reports, protocols, CTD clinical summaries, investigator brochures) across multiple therapeutic areas
* Ensure all documents are clear, accurate, and aligned with relevant regulatory guidelines and client expectations
* Review and quality-check clinical documentation, data outputs, and other supporting materials
* Liaise with client teams to manage timelines, address queries, and resolve content or compliance issues
* Conduct background research to confirm references and stay aligned with current regulatory requirements
* Work across multiple projects while maintaining high standards and meeting deadlines
Requirements:
* Previous experience producing regulatory documentation within a medical communications agency or pharmaceutical environment
* Strong understanding of regulatory writing standards and processes (e.g., ICH, GCP)
* Life sciences degree (advanced degree preferred)
* High attention to detail, critical thinking, and the ability to work independently or as part of a team
* Experience with reviewing protocols, statistical analysis plans, and clinical data
* Excellent verbal and written communication skills
What’s on Offer:
This role offers the opportunity to work in a high-impact environment with a global client base, excellent support systems, and the ability to work remotely or flexibly. You will also benefit from structured career development, internal training, and a strong culture of collaboration and professionalism.
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