Support Health Canada and U.S. FDA submissions as dicentra’s Senior Regulatory Writer, fully remote from Ontario. Deliver scientifically accurate documentation.

In this senior role, you will prepare clinical and scientific documents supporting regulatory submissions and clinical trial execution. dicentra serves life sciences and dietary supplement industries through regulatory consulting and clinical research. Engagement may be full time, part time, or project-based consulting.

Key Responsibilities:
Prepare clinical documentation for regulatory authority submissions
Lead authoring, review, and revision of study protocols
Develop essential investigator and informed consent documentation
Coordinate stakeholder feedback across multiple writing assignments




Ensure documents meet applicable regulatory guidance and standards

Requirements:
Five or more years of relevant medical writing experience
Demonstrated authorship of protocols, ICFs, IBs, or CSRs
Understanding of clinical trial design and methodologies
Knowledge of Health Canada and FDA regulatory expectations
Ability to collaborate with statisticians, specialists, and sponsors

Apply regulatory writing expertise, clinical documentation experience, and stakeholder coordination to dicentra’s Ontario-based remote assignments.

📌 Senior Regulatory Submission Writer Montreal
🏢 dicentra
📍 Montreal