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Regulatory Writer - Remote

Meet Life Sciences

Wolverhampton

Hybrid

GBP 45,000 - 65,000

Full time

Yesterday
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Job summary

A leading medical communications agency is seeking an experienced Regulatory Medical Writer to contribute to regulatory submissions across various therapeutic areas. The role involves developing compliant documentation, collaborating with clients and internal teams, and maintaining high standards in a flexible work environment. This position offers excellent career development opportunities and a collaborative culture.

Benefits

Structured career development
Internal training
Flexible working options
Collaborative culture
Professionalism

Qualifications

  • Experience producing regulatory documentation in a medical communications agency or pharmaceutical environment.
  • Strong understanding of regulatory writing standards (e.g., ICH, GCP).
  • Experience with reviewing protocols and clinical data.

Responsibilities

  • Write and edit regulatory documents like clinical study reports and protocols.
  • Review clinical documentation and manage timelines with client teams.
  • Conduct background research to confirm references and regulatory alignment.

Skills

Attention to detail
Critical thinking
Excellent communication
Ability to work independently
Regulatory writing standards knowledge

Education

Life sciences degree
Advanced degree (preferred)

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.

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