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 (Canada)
🏢 dicentra
📍 Canada