Senior Medical Writer/Principal Medical Writer (Medical)

TL;DR

Senior Medical Writer/Principal Medical Writer (Medical): Leading the development of high-quality clinical study documents with an accent on clinical document planning, writing, and regulatory compliance. Focus on authoring complex content for protocols, IBs, and CSRs while ensuring adherence to ICH, FDA, and GCP guidelines.

Location: Remote, Canada

Salary: $101,800 - $184,700

Company

hirify.global is a specialized organization focusing on precision medicine and clinical research services.

What you will do

• Lead the development of clinical study documents including protocols, IBs, ICF templates, DSURs, and CSRs.
• Manage the document lifecycle from template to final approved version in collaboration with sponsors and vendors.
• Formulate key messages from clinical study data and author complex technical content.
• Perform literature-based research to support writing activities.
• Contribute to the maintenance of medical writing SOPs, templates, and work instructions.
• Perform QC reviews to ensure high quality and regulatory compliance.

Requirements

• BS degree in a scientific or medical discipline.
• Must be based in Canada.
• 5+ years of experience as a Senior Medical Writer or 7+ years as a Principal Medical Writer in sponsor or CRO settings.
• Deep understanding of ICH, FDA, GCP regulations and eCTD requirements.
• Proficiency with MS Office suite (Word, Excel, PowerPoint) and Adobe Acrobat.

Nice to have

• Advanced degree (MS/PhD).
• Experience in oncology or rare diseases, specifically protocol and CSR development.

Culture & Benefits

• Eligible for a discretionary annual bonus.
• Comprehensive health insurance and retirement savings benefits.
• Life insurance, disability benefits, and parental leave.
• Paid time off for vacation and sick leave.