Senior Medical Writer (Regulatory Writing)

Location: Remote in Canada; Toronto, ON, Canada

Company

hirify.global is a data-focused contract research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission services.

What you will do

• Evaluate and interpret medical literature to select scientifically rigorous primary resources for study design and regulatory documentation.
• Write and edit clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2 documents, presentations, and publications.
• Manage writing assignments, timelines, workflows, and deliverables under minimal supervision.
• Coordinate project activities directly and independently with clients and internal project teams.
• Contribute substantially to or manage the production of interpretive guides.
• Mentor medical writers and other project team members involved in the writing process.

Requirements

• At least 3 years of experience in the pharmaceutical industry.
• At least 3–5 years of regulatory writing and clinical medical writing experience.
• Substantial experience authoring clinical study protocols as lead author.
• Experience leading or managing project teams while authoring regulatory documents under aggressive timelines.
• Bachelor’s, Master’s, or Ph.D. in a scientific, medical, or clinical discipline is preferred.
• Strong writing, organizational, multitasking, clinical data, and MS Word, Excel, and PowerPoint skills.

Nice to have

• Experience with regulatory submissions and clinical study reports presented to regulatory authorities.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines.
• Experience with orphan drug designations and PSP/PIPs.

Culture & Benefits

• Remote full-time position supporting projects across pharmaceutical, biotech, and medical device industries.
• Collaborative environment focused on scientific quality, regulatory expertise, and customer service.
• Opportunities to mentor colleagues and contribute to complex clinical development programs.