Senior Regulatory Medical Writer
New
CanadaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 4 years of regulatory medical writing experience
- Required Skills
- Stakeholder management
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.
Responsibilities
- 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.
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