Principal Medical Writer

TL;DR

Principal Medical Writer (Medical/Regulatory): Authoring and managing complex clinical and regulatory documentation for drug and device programs with an accent on regulatory compliance and data interpretation. Focus on leading cross-functional deliverables, mentoring junior staff, and ensuring high-quality submissions for global regulatory bodies.

Location: Must be based in Canada. Supports remote work with a preference for hybrid collaboration for those near office locations.

Company

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

What you will do

• Independently author and edit high-quality clinical, safety, and regulatory documents including protocols, IBs, ICFs, and submission-level documents like NDA, BLA, and MAA.
• Lead cross-functional coordination of resources to manage medical writing and QC deliverables.
• Manage client expectations, lead team meetings, and oversee project timelines and budgets.
• Review statistical analysis plans and table/figure/listing shells for accuracy and consistency.
• Supervise, train, and mentor less experienced medical writers.
• Ensure adherence to regulatory standards such as ICH E3, E6(R2), and EU MDR/IVDR.

Requirements

• Minimum 7 years of experience in writing clinical or regulatory documents for a CRO, pharmaceutical, or biotech company.
• Advanced knowledge of clinical research principles and regulatory submission requirements (FDA and others).
• Expert proficiency in MS Word, including tables, graphs, and figures.
• Strong project management skills and ability to communicate effectively with clients and internal stakeholders.
• English language proficiency and familiarity with AMA style.
• Bachelor’s degree or higher in a medical or scientific discipline.

Culture & Benefits

• Commitment to diversity, equity, and inclusion with a focus on authentic self-expression.
• Supportive environment for professional growth and mentorship.
• Holistic approach as an Equal Opportunity Employer.
• Emphasis on collaborative and entrepreneurial spirit.