Senior Medical Writer (Medical)

TL;DR

Senior Medical Writer (Medical): Leading the development of high-quality clinical study documents including protocols, IBs, and CSRs with an accent on regulatory compliance and eCTD requirements. Focus on formulating key messages from clinical study data and ensuring smooth document management across all phases of development.

Location: Remote (Canada)

Salary: $101,800 - 152,600

Company

hirify.global is a specialized organization providing clinical study document development and regulatory compliance services.

What you will do

• Lead the planning, writing, editing, and QC review of clinical study protocols, IBs, ICF templates, DSURs, and CSRs.
• Ensure all documents comply with the Precision MW Style Guide, SOPs, and regulatory guidelines such as ICH, FDA, and GCP.
• Manage document lifecycles from template to final approval in collaboration with Sponsors and external vendors.
• Independently formulate key messages from clinical study data and author complex technical content.
• Contribute to the maintenance of medical writing processes, SOPs, and work instructions.
• Perform literature-based research to support writing activities.

Requirements

• BS degree or equivalent in a scientific or medical discipline.
• 5+ years of experience as a medical writer in a sponsor or CRO setting.
• Must be based in Canada.
• Proficiency with Microsoft Word, Excel, PowerPoint, Teams, and Adobe Acrobat.
• Deep understanding of ICH, FDA, GCP, eCTD requirements, and clinical trial transparency (EudraCT, CT.gov).

Nice to have

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

Culture & Benefits

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