Senior Medical Writer - Regulatory Submissions Lead

MMS Holdings Inc; Calgary; À distance; CAD 90 000 - 120 000; Plein temps

Résumé du poste

MMS Holdings Inc. Calgary seeks an experienced Regulatory Medical Writer to evaluate literature, craft regulatory documents, and coordinate with client teams. This role emphasizes strong writing, regulatory submissions expertise, and leadership of writing projects.

You will mentor peers, manage timelines, and ensure adherence to ICH guidelines and industry standards while delivering high-quality clinical documentation for regulatory submissions.

Qualifications

• Bachelor’s degree in scientific/medical field with regulatory writing exposure.
• Regulatory submissions experience is highly valued.
• Experience leading author teams under tight timelines.

Responsabilités

• Critically evaluate literature to support study design and regulatory documents.
• Write and edit clinical study reports and regulatory modules with accuracy.
• Meet timelines and maintain writing workflows across teams.
• Coordinate with clients, project teams and department representatives.
• Mentor junior writers and drive adherence to templates and guides.

Connaissances

Regulatory writing

Regulatory submissions

Leadership experience

Client communication

Clinical data understanding

Exceptional writing

Project management

ICH guidelines

Formation

Bachelor’s degree in scientific/medical field

Masters or PhD preferred

Outils

MS Word

MS Excel

PowerPoint

Description du poste

MMS Holdings Inc. Calgary seeks an experienced Regulatory Medical Writer to evaluate literature, craft regulatory documents, and coordinate with client teams. This role emphasizes strong writing, regulatory submissions expertise, and leadership of writing projects.

You will mentor peers, manage timelines, and ensure adherence to ICH guidelines and industry standards while delivering high-quality clinical documentation for regulatory submissions.