Use advanced eCTD publishing expertise to deliver compliant global submissions for clinical research programmes, including oncology and rare diseases. This fully remote opportunity is based in Canada.

This senior-level position independently manages regulatory publishing work from planning through final submission. You will format documents, perform quality control, and coordinate Medical Writing, Biostatistics, Programming, and Regulatory Affairs contributors. You will also represent Regulatory Operations, troubleshoot complex document challenges, and promote publishing best practices.

Key Responsibilities:

- Publish high-quality electronic regulatory submission documentation
- Ensure documents meet standards, technical requirements, and guidelines
- Represent Regulatory Operations in critical project discussions




- Resolve complex regulatory publishing questions and escalations
- Contribute to workflow and operational process improvements

Requirements:

- At least eight years in regulatory publishing or clinical research
- Experience with eCTDmanager, DocuBridge, or eCTDXpress
- Advanced Microsoft Word formatting and template expertise
- Understanding of medical and statistical terminology
- Exceptional accuracy, compliance, and attention to detail

Bring eCTD software mastery, accurate document review, and regulatory operations experience to complex electronic submissions.

📌 Senior eCTD Regulatory Operations Publisher (Canada)
🏢 Jobgether
📍 Canada