Senior Medical Writer/Principal 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 Senior Medical Writer/Principal Medical Writer based in Canada.

This role offers the opportunity to lead the creation of critical clinical documentation that supports the development of innovative therapies and advances healthcare research. The successful candidate will manage complex medical writing projects across clinical development phases, ensuring accuracy, compliance, and high-quality deliverables. Working closely with sponsors, internal teams, and external partners, this position plays a key role in translating clinical data into clear and impactful regulatory documents. The role requires strong scientific knowledge, exceptional writing capabilities, and meticulous attention to detail. You will contribute to improving medical communication processes while working in a collaborative, fast-paced environment. This is an ideal opportunity for an experienced medical writer seeking meaningful impact within the clinical research ecosystem.

Accountabilities:: The Senior Medical Writer/Principal Medical Writer will be responsible for leading the planning, development, review, and delivery of high-quality clinical documents while ensuring alignment with regulatory standards, internal procedures, and client expectations. The role requires strong ownership of writing projects, effective collaboration across teams, and the ability to transform complex clinical data into clear scientific communications.

Lead the planning, writing, editing, formatting, and quality control review of clinical documents, including protocols, investigator brochures, informed consent templates, DSURs, clinical study reports, and patient narratives.

Manage document development workflows from initial templates through final approval, coordinating effectively with sponsors, vendors, and internal project teams.

Interpret clinical study data and independently develop clear, accurate key messages and scientific content.

Apply strong medical writing expertise to produce complex regulatory documents while maintaining consistency, accuracy, and compliance.

Conduct literature-based research to support clinical writing activities and strengthen document quality.

Ensure all deliverables comply with applicable regulatory guidelines, including ICH, FDA, GCP, and eCTD requirements.

Contribute to the improvement and maintenance of medical writing processes, templates, SOPs, and work instructions.

Communicate effectively with internal stakeholders and clients to ensure alignment, resolve challenges, and deliver projects successfully.

Manage multiple high-priority assignments while maintaining exceptional quality and meeting deadlines.

Requirements:

The ideal candidate brings extensive medical writing experience within pharmaceutical, biotechnology, or clinical research environments, along with strong regulatory knowledge and excellent communication skills. This position requires someone who can work independently, manage complex projects, and deliver accurate scientific documentation in a fast-paced setting.

Bachelor’s degree or equivalent in a scientific, medical, or related discipline with relevant medical writing experience.

5+ years of experience as a Senior Medical Writer in a sponsor or CRO environment, or 7+ years of experience as a Principal Medical Writer.

Strong understanding of clinical development processes, regulatory requirements, and clinical trial documentation standards.

Experience with ICH guidelines, FDA regulations, GCP requirements, clinical trial transparency requirements, and eCTD submission standards.

Proven ability to independently author complex clinical documents and synthesize clinical data into meaningful content.

Excellent written and verbal communication skills with the ability to collaborate effectively with clients and cross-functional teams.

Exceptional attention to detail, organizational skills, and ability to manage multiple competing priorities.

Ability to work independently with minimal supervision while maintaining high-quality standards.

Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, Teams, and Adobe Acrobat.

Advanced degree (MS/PhD) preferred.

Experience in oncology and/or rare disease therapeutic areas, particularly protocol and CSR development, is a plus.

Benefits:

Competitive salary range of $101,800 - $184,700 USD depending on experience, qualifications, and location.

Eligibility for a discretionary annual bonus program.

Comprehensive health insurance benefits.

Retirement savings benefits.

Life insurance and disability benefits.

Parental leave support.

Paid time off, including vacation and sick leave.

Opportunity to work on impactful clinical research programs within a collaborative environment.

Professional growth opportunities within a global healthcare and life sciences organization.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1