Senior Ectd Regulatory Operations Publisher

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 documentationEnsure documents meet standards, technical requirements, and guidelinesRepresent Regulatory Operations in critical project discussionsResolve complex regulatory publishing questions and escalationsContribute to workflow and operational process improvementsRequirements:
At least eight years in regulatory publishing or clinical researchExperience with eCTDmanager, DocuBridge, or eCTDXpressAdvanced Microsoft Word formatting and template expertiseUnderstanding of medical and statistical terminologyExceptional accuracy, compliance, and attention to detailBring eCTD software mastery, precise document review, and regulatory operations experience to complex electronic submissions.
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