Senior/Principal Medical Writer

Jobgether · Canada

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior/Principal Medical Writer based in Canada.

You will join a highly specialized medical writing team supporting global pharmaceutical and biotech clients in the preparation of high-impact regulatory and clinical documentation. In this role, you will act as a lead writer across complex, multi-document programs that are essential to clinical development and regulatory approval processes. You will collaborate closely with cross-functional clinical teams, client stakeholders, and subject matter experts to produce scientifically rigorous, submission-ready documentation. The position combines deep scientific writing expertise with project coordination, requiring strong ownership of timelines, quality, and compliance. You will contribute to a fast-growing, globally connected environment where precision, clarity, and regulatory excellence are critical. This role also offers the opportunity to mentor other writers and influence best practices across projects. It is well suited for an experienced medical writer who thrives in a client-facing, detail-driven, and collaborative setting.

Accountabilities:

Lead the preparation of clinical regulatory documents including Clinical Study Protocols, Clinical Study Reports, CTD summaries, Investigator Brochures, IMPDs/INDs, and scientific publications.
Coordinate with client teams, authors, and internal stakeholders to ensure accurate and high-quality document development.
Manage end-to-end document timelines, review cycles, and project deliverables in alignment with regulatory and client expectations.
Ensure adherence to applicable SOPs, regulatory guidelines (ICH, FDA, EMA), and quality standards.
Oversee and guide supporting writers and QC specialists involved in assigned projects.
Provide expert document-specific guidance and regulatory writing advice to clients.
Track and manage project scope, timelines, and where applicable, budget considerations.
Work within regulatory document management systems to maintain accuracy, traceability, and compliance.
Contribute to continuous improvement of writing standards, processes, and best practices.

Requirements:

Bachelor’s degree in a scientific or pharmacy-related field (advanced degree not required).
3–5+ years of experience in regulatory medical writing within the pharmaceutical or life sciences industry.
Proven experience as a lead writer on key regulatory documents such as Clinical Study Protocols, CSRs, IBs, CTD modules, IMPDs/INDs, or scientific publications.
Strong understanding of global regulatory frameworks including ICH, FDA, and EMA guidelines.
Experience coordinating multi-document projects and managing review cycles with global, cross-functional teams.
Ability to manage multiple concurrent projects in a deadline-driven environment.
Strong communication and interpersonal skills, with experience interacting directly with clients and authors.
High attention to detail and strong appreciation for scientific accuracy and clarity in writing.
Proficiency with document management systems and regulatory review tools.
Strong ability to remain organized and effective under tight timelines.
Nice to have (Principal level): experience leading large, global projects, mentoring writers, managing budgets, and working across multiple therapeutic areas.

Benefits:

Competitive salary range of $121,000 – $163,900 CAD, with variation based on experience and role level.
Annual performance-based bonus opportunity.
Comprehensive health benefits including medical, dental, vision, disability, and life insurance.
RRSP retirement savings plan with company matching contributions.
Generous paid time off including vacation, holidays, personal days, and sick leave.
Full coverage of professional memberships and conference participation (e.g., AMWA).
Remote-first work model with flexibility across Canada.
Continuous learning, training, and professional development opportunities.
Wellness initiatives and team engagement activities supporting work-life balance.

Healthcare pay context

Based on 3,430 disclosed Healthcare salaries on RoleSuite, the role pays a median of $113K/year, with most offers between $87K and $167K (10th–90th percentile: $67K–$257K).

This posting lists $121K–$164K, above the $113K market median.

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Senior/Principal Medical Writer

Accountabilities:

Requirements:

Benefits:

Healthcare pay context

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