Senior Clinical Regulatory Writer

Lead clinical protocol and regulatory writing for dicentra from Ontario, working fully remotely across clinical research projects. Translate complex scientific data into compliant documents.

As a Senior Medical and Regulatory Writer, you will support pharmaceuticals, medical devices, and natural health products. You will independently manage complex assignments across dicentra’s clinical research portfolio. The work includes clinical documentation, regulatory submissions, and scientific evidence synthesis.

Key Responsibilities:

• Author and revise clinical study protocols and amendments
• Develop informed consent forms and Investigator’s Brochures
• Write Clinical Study Reports integrating findings and statistical analyses
• Prepare regulatory documentation for Health Canada and FDA submissions
• Manage review cycles and deliver documents within agreed timelines

Requirements:

• Bachelor’s degree in life, health, or related sciences
• Five or more years of medical or regulatory writing experience
• Authorship experience with clinical trial documents
• Knowledge of clinical research methods and statistical data interpretation
• Working knowledge of ICH-GCP, ICH E3, and regulatory expectations

Bring senior clinical writing, regulatory knowledge, and independent project delivery to dicentra’s fully remote Ontario-based work.