Senior Medical Writer (Pharma)

TL;DR

Senior Medical Writer (Pharma): Authoring and editing high-quality clinical and regulatory documentation for drug and device programs with an accent on compliance with FDA and ICH standards. Focus on managing complex submission-level documents, collaborating with cross-functional teams, and mentoring junior staff to ensure project delivery within timelines and budget.

Location: Must be based in Canada. The role supports remote work, with a hybrid option encouraged for those within commuting distance of an office.

Company

hirify.global provides expert consulting and clinical research solutions to biotech, medical device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Author and edit clinical, safety, and regulatory documents including protocols, study reports, and submission-level filings.
• Manage client expectations and lead project meetings to ensure deliverables meet regulatory standards.
• Collaborate with clinical operations, biostatistics, and regulatory affairs teams to produce high-quality documentation.
• Perform peer reviews and QC checks on documents to ensure accuracy and consistency.
• Supervise and mentor less experienced medical writers.
• Maintain audit trails and adhere to established SOPs and client-approved templates.

Requirements

• Minimum 5 years of experience in medical writing for drugs, biologics, or medical devices within a CRO, pharma, or biotech environment.
• Advanced knowledge of clinical research principles and regulatory submission processes (FDA, ICH).
• English language proficiency with expert knowledge of AMA style.
• Strong project management skills and ability to work independently on multiple deliverables.
• Bachelor’s degree or higher in a medical or scientific discipline.
• Must be based in Canada.

Culture & Benefits

• Commitment to diversity, equity, and inclusion with a focus on authentic self-expression.
• Supportive environment that encourages innovation and entrepreneurial spirit.
• Flexible work arrangements with support for remote and hybrid collaboration.
• Holistic approach as an Equal Opportunity Employer.