Regulatory Writer - Remote

Meet Life Sciences
Bristol
7 months ago
Applications closed

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We are currently partnering with a leading global medical communications agency to support their search for an experiencedRegulatory 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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