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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Medical Writer – Client Dedicated based in Canada.
This is a high-impact, sponsor-embedded role focused on leading the development of complex clinical regulatory documents across Phase II–IV programs.
You will take ownership of critical deliverables such as clinical protocols, Investigator’s Brochures, and regulatory submissions from start to finish.
The role involves close collaboration with global cross-functional teams, ensuring scientific accuracy, compliance, and alignment with development strategies.
You will act as a key driver of document planning, stakeholder coordination, and timeline management in a fast-paced, matrix environment.
This position offers exposure to high-complexity clinical data and the opportunity to directly influence the quality and clarity of global regulatory communications.
It is well suited for an experienced medical writer who thrives in leadership, enjoys cross-functional collaboration, and can operate seamlessly within sponsor-led environments.
Accountabilities:
- Lead end-to-end development of high-complexity regulatory documents including Clinical Protocols, Investigator’s Brochures (IBs), and submissions for Phase II–IV studies.
- Organize and facilitate kick-off meetings, cross-functional reviews, and comment-resolution cycles to ensure timely and high-quality deliverables.
- Coordinate input from global stakeholders including clinical, statistical, data management, and programming teams to ensure scientific and regulatory alignment.
- Interpret clinical trial data and translate findings into clear, accurate, and compliant regulatory documentation.
- Ensure adherence to project timelines, sponsor expectations, and regulatory standards throughout the document lifecycle.
Requirements:
- Advanced degree in life sciences (Master’s or PhD preferred) or equivalent scientific background.
- Minimum of 4 years of regulatory medical writing experience, including strong expertise in CSRs, protocols, and related clinical documents.
- At least 2 years of experience leading medical writing projects or acting as a project lead in a matrix environment.
- Proven ability to manage multiple stakeholders and drive consensus in complex, global teams.
- Strong communication, leadership, and organizational skills with a proactive and detail-oriented mindset.
- Ability to integrate seamlessly into sponsor teams and operate effectively in fast-paced, collaborative environments.
Benefits:
- Competitive compensation aligned with senior-level regulatory writing expertise.
- Opportunity to work on global, high-impact clinical development programs.
- Flexible work arrangements with a remote-friendly structure.
- Exposure to cross-functional and international teams across multiple regions.
- Career development opportunities through training, mentorship, and leadership pathways.
- Access to a global network of clinical and scientific experts.
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