Regulatory Writer - Remote - Studentjob.co.uk

Regulatory Writer - Remote - Studentjob.co.uk

We are partnering with a leading global medical communications agency to find an experiencedRegulatory Medical Writer. This role involves creating high-quality, compliant documentation for global regulatory submissions across various therapeutic areas, working with a collaborative team.

About the Role:

You will develop documents such as clinical study reports, protocols, CTD summaries, and investigator brochures, ensuring clarity, accuracy, and regulatory compliance. Collaboration with internal teams and clients is key to meet deadlines and standards.

Key Responsibilities:

• Write and edit regulatory documents across multiple therapeutic areas
• Ensure documents meet regulatory guidelines and client expectations
• Review clinical documentation and data outputs for quality
• Coordinate with clients on timelines and queries
• Research regulatory requirements and references
• Manage multiple projects while maintaining quality and deadlines

Requirements:

• Experience in regulatory documentation within medical communications or pharmaceutical sectors
• Understanding of regulatory standards (e.g., ICH, GCP)
• Degree in life sciences (advanced degree preferred)
• Attention to detail, critical thinking, and independence
• Experience reviewing protocols and clinical data
• Excellent communication skills

What’s on Offer:

Work in a high-impact, global environment with flexible remote options, structured career development, and a collaborative culture.

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