Regulatory Writer (Senior/Principal)
EPM is partnered with a leading Medical Communications Agency to support a number of projects as they expand their Medical & Regulatory Writing team. They are currently looking for Regulatory Writers (Senior/Principal level). See summary below:
Project Overview
- Project Type: Regulatory Writing (Submissions)
- Location: Europe, Fully Remote - UK Preferred
- Contract Type: Permanent, Full-Time
- Ideal Start Date: Immediately
- Language Requirements: English
Key Responsibilities
- Lead, mentor, and develop regulatory writers, providing guidance on client issues and supporting knowledge sharing across the team.
- Serve as primary contact for designated projects, overseeing scientific and technical quality and ensuring alignment with client expectations.
- Manage delivery of multiple projects, meeting quality standards, timelines, and budgets while tracking scope in partnership with Project Management.
- Contribute to regulatory writing training and support line management responsibilities as needed.
- Provide strategic input on complex programs (e.g., submissions), advising on regulatory writing processes, best practices, and client procedures.
Requirements
- Strong technical and scientific capabilities with a proven track record in delivering high‑quality regulatory documents.
- Excellent communicator with the ability to coach and mentor junior team members on client and project‑related challenges.
- Skilled at managing multiple projects and consistently producing clear, accurate, and well‑written deliverables within deadlines.
- Proactive in sharing knowledge and supporting team development to strengthen overall capability and collaboration.
If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.
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