Principal Medical Writer — Regulatory Leader & Mentor

MMS; Montreal; Vor Ort; CAD 70.000 - 110.000; Vollzeit

Zusammenfassung

MMS, a data-focused clinical research organization, seeks a Medical Writer with 6+ years of regulatory writing experience to join our Montreal team. You will evaluate literature, write protocols, investigator’s brochures, and regulatory study reports while ensuring scientific rigor and timely delivery.

You will mentor junior writers, interact with clients, lead projects under minimal supervision, and contribute to regulatory submissions.

Qualifikationen

• Bachelor’s, Master’s or PhD in scientific/medical field required with at least 6 years of regulatory writing experience; Master’s or PhD preferred
• Substantial clinical study protocol experience as lead author
• Experience leading teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) a plus
• Understanding of clinical data and strong writing skills
• Knowledge of federal regulations, GCP and ICH guidelines is a plus

Aufgaben

• Critically evaluate, analyze, and interpret medical literature to select primary materials for study design
• Write and edit regulatory documents including protocols, investigators brochures, study reports, and consent forms
• Maintain timelines and workflows for writing assignments
• Interact with clients and coordinate project facets; mentor writers
• Produce interpretive guides and manage project teams when needed
• Ensure compliance with client templates and style guides

Kenntnisse

Regulatory writing

Lead author on protocols

Team leadership

Regulatory submissions

Excellent writing

Project management

Ausbildung

Bachelor’s, Master’s or PhD in scientific/medical field

Tools

MS Word

MS Excel

PowerPoint

Jobbeschreibung

MMS, a data-focused clinical research organization, seeks a Medical Writer with 6+ years of regulatory writing experience to join our Montreal team. You will evaluate literature, write protocols, investigator’s brochures, and regulatory study reports while ensuring scientific rigor and timely delivery.

You will mentor junior writers, interact with clients, lead projects under minimal supervision, and contribute to regulatory submissions.