Regulatory Writer - Remote in Altrincham

Job description

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.

Extra information

Status

Open

Education Level

Secondary School

Location

Altrincham

Type of Contract

Part-time jobs

Published at

09-07-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English