Senior Medical Writer — Regulatory Submissions & Leadership

MMS; Calgary; On-site; CAD 90,000 - 120,000; Full time

Job summary

MMS is a data-focused CRO delivering regulatory and clinical writing support across pharmaceutical, biotech, and medical device sectors. The Medical Writer will critically evaluate literature, write and edit pivotal regulatory documents, and mentor junior writers to ensure high-quality submissions.

Responsibilities include managing timelines, coordinating with clients, and applying expert knowledge of ICH/GCP standards to multiple modules and study reports.

Qualifications

• Experience in pharmaceutical regulatory writing and clinical writing is required.
• Lead authoring of regulatory documents with aggressive timelines.
• Substantial clinical study protocol experience is preferred.
• Expertise with client templates and style guides is essential.

Responsibilities

• Critically evaluate, analyze, and interpret medical literature to select primary resources.
• Write and edit clinical development documents (protocols, brochures, study reports, ICFs).
• Complete assignments on time and maintain timelines.
• Mentor medical writers and project team members.
• Interact with clients to coordinate all project facets.

Skills

Regulatory writing

Clinical writing

Project leadership

Team mentoring

Client coordination

Education

Bachelor's degree

Master's degree

PhD

Tools

MS Word

MS Excel

PowerPoint

Job description

MMS is a data-focused CRO delivering regulatory and clinical writing support across pharmaceutical, biotech, and medical device sectors. The Medical Writer will critically evaluate literature, write and edit pivotal regulatory documents, and mentor junior writers to ensure high-quality submissions.

Responsibilities include managing timelines, coordinating with clients, and applying expert knowledge of ICH/GCP standards to multiple modules and study reports.