Senior Medical Writer & Regulatory Submissions Lead

MMS; Calgary; On-site; CAD 85,000 - 120,000; Full time

Job summary

MMS is a data-focused CRO seeking a Medical Writer to critically evaluate literature, craft regulatory documents, and manage writing projects with minimal supervision. You will author protocols, briefs, study reports, consent forms, and safety summaries for regulatory submissions.

The role requires 6+ years in regulatory writing, leadership experience, and strong MS Word skills. A PhD or Masters is preferred; collaboration with global teams is essential.

Qualifications

• Bachelor's/masters/PhD in scientific, medical or clinical field.
• Minimum 6 years regulatory writing experience; masters/PhD preferred.
• Lead author on clinical study protocols and regulatory documents.

Responsibilities

• Critically evaluate literature to select primary materials for study design and bias-free reporting.
• Write/edit clinical development documents: protocols, investigators' brochures, study reports and safety summaries.
• Maintain timelines, mentor writers, and ensure compliance with regulatory standards.

Skills

Regulatory writing

Team leadership

Project management

MS Word

Communication

Education

Bachelor's degree in scientific/medical field

Master's degree in scientific/medical field

PhD in relevant field

Tools

PowerPoint

MS Word

Regulatory templates

Job description

MMS is a data-focused CRO seeking a Medical Writer to critically evaluate literature, craft regulatory documents, and manage writing projects with minimal supervision. You will author protocols, briefs, study reports, consent forms, and safety summaries for regulatory submissions.

The role requires 6+ years in regulatory writing, leadership experience, and strong MS Word skills. A PhD or Masters is preferred; collaboration with global teams is essential.