Medical Writer
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Writer based in Canada.
This role sits at the intersection of clinical research, scientific communication, and regulatory excellence, supporting the creation and quality assurance of high-impact clinical documentation used across global drug development programs. You will contribute to the preparation and review of key clinical study materials, ensuring scientific accuracy, regulatory compliance, and consistency across deliverables. Working closely with cross-functional teams, you will help translate complex clinical and statistical data into clear, submission-ready documents that support decision-making and regulatory filings. The environment is collaborative, detail-driven, and quality-focused, with exposure to multiple therapeutic areas and study phases. This position offers the opportunity to influence the integrity of clinical evidence while working in a fast-paced, globally connected research setting. It is well suited for professionals who enjoy precision writing, scientific rigor, and meaningful impact on healthcare innovation.
Accountabilities
In this role, you will be responsible for supporting the development, review, and quality control of a wide range of clinical and scientific documents while ensuring accuracy, consistency, and compliance with regulatory standards. You will collaborate closely with project teams to meet timelines and maintain high-quality deliverables.
- Perform detailed quality control (QC) reviews of clinical documents, including clinical study protocols, Clinical Study Reports (CSRs), pharmacokinetic reports, statistical reports, and scientific publications, ensuring accuracy, consistency, and adherence to templates and standards.
- Verify scientific and numerical accuracy across tables, listings, figures, abbreviations, references, and protocol-related content, ensuring alignment with source data and regulatory requirements.
- Lead or contribute to the drafting, editing, and finalization of clinical documents, applying therapeutic and methodological understanding to interpret study results effectively.
- Ensure proper document formatting, version control, and e-publishing activities, including PDF generation, hyperlinking, pagination, and compilation of appendices and tables.
- Manage document review cycles by incorporating stakeholder feedback, coordinating QC findings resolution, and ensuring timely delivery of final outputs.
- Support literature searches, data interpretation, and preparation of scientific materials such as manuscripts, abstracts, posters, and regulatory submissions.
- May contribute to clinical operations support activities, including committee documentation, meeting coordination, and reporting deliverables.
- Advanced degree in Life Sciences, Medical Sciences, Clinical Sciences, or a related field (PhD preferred; Master’s with relevant experience accepted).
- Minimum 2+ years of medical writing experience in a clinical trial or pharmaceutical environment, ideally including exposure to regulatory submissions and CSRs.
- Strong understanding of clinical trials, biostatistics, and ICH-GCP guidelines, including CSR structure and regulatory expectations.
- Proven ability to interpret complex clinical and statistical data and translate findings into clear, accurate scientific documentation.
- High proficiency in Microsoft Office and document management tools such as Adobe Acrobat; familiarity with pharma publishing tools is an asset.
- Excellent written and verbal communication skills, with strong attention to detail and consistency in scientific writing.
- Ability to manage multiple projects simultaneously while maintaining quality and meeting tight deadlines.
- Strong collaboration skills, with the ability to work effectively across cross-functional and global teams.
- Competitive salary range aligned with experience and expertise ($65,000 – $100,000 CAD annually)
- Comprehensive health coverage including medical, dental, and vision insurance
- Life insurance, AD&D coverage, and short- and long-term disability benefits
- Pension plan and retirement savings support
- Paid time off, sick leave, and performance-based bonus eligibility
- Tuition and professional development reimbursement programs
- Fitness and wellness reimbursement initiatives
- Employee assistance program (EAP) for personal and professional support
- Flexible remote work arrangement across Canada
Requirements
This role requires a strong foundation in clinical research writing, scientific interpretation, and regulatory documentation within a pharmaceutical or CRO environment. The ideal candidate is highly detail-oriented, organized, and comfortable managing multiple projects in a deadline-driven setting.