Assistant Dossier Réglementaire — Horaires Flexibles

Indero; Montreal; On-site; CAD 30,000 - 60,000; Full time

Job summary

A contract research organization in Montreal seeks a Regulatory Documents Assistant. Responsibilities include managing the Trial Master File and reviewing regulatory documents for accuracy. The role requires a college degree and experience in clinical research. The ideal candidate is bilingual in French and English and has strong organizational skills. This full-time position offers a flexible work schedule and a comprehensive benefits package.

Benefits

Flexible work schedule

Permanent full-time position

Company benefits package

Ongoing learning and development

Qualifications

• Experience in clinical research in the biotechnology, pharmaceutical, or CRO industry required.

Responsibilities

• Establish and maintain the Trial Master File (TMF).
• Perform record review of essential documents for accuracy.
• Set up the Investigator’s Study File (ISF) binders.

Skills

Knowledge of clinical trial operations

Bilingual (French and English)

Computer skills including proficiency in Microsoft Word and Excel

Ability to organize work and prioritize tasks

Attention to detail and accuracy

Versatile and comfortable in a multitasking environment

Education

College degree

Job description

A contract research organization in Montreal seeks a Regulatory Documents Assistant. Responsibilities include managing the Trial Master File and reviewing regulatory documents for accuracy. The role requires a college degree and experience in clinical research. The ideal candidate is bilingual in French and English and has strong organizational skills. This full-time position offers a flexible work schedule and a comprehensive benefits package.