Senior Medical Writer - Remote, Regulatory & Publications

Placements24; Kimberley; Hybrid; CAD 90,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

Professional development

Remote work flexibility

Job summary

Placements24 in Kimberley, Canada is seeking a Senior Medical Writer to join its regulatory affairs and communications team. You will craft regulatory and scientific documents, including CSRs, regulatory submissions, and publications, ensuring accuracy and compliance.

You should have 5+ years of medical writing experience in pharma/biotech, strong English, and the ability to translate complex data into clear narratives for global audiences. A life sciences background is required.

Qualifications

• 5+ years of experience as Medical Writer in pharmaceutical or biotech industry.
• Experience writing Clinical Study Reports (CSRs) and regulatory submission documents.
• Excellent command of English language, grammar, and scientific terminology.

Responsibilities

• Author, edit, and review regulatory and scientific documents (CSRs, INDs, NDAs).
• Ensure documents meet regulatory requirements (ICH, FDA, EMA, SAHPRA) and internal guidelines.
• Collaborate with clinical development, regulatory affairs, biostatistics, and medical affairs teams to gather information and ensure accuracy.
• Manage document timelines and deliverables across contributors.
• Contribute to medical communication strategies and publication plans.
• Maintain up-to-date knowledge of regulatory guidelines and medical writing best practices.

Skills

Regulatory writing

Education

Bachelor's or Master's in life science

Tools

Microsoft Office

Document management systems

Job description

Placements24 in Kimberley, Canada is seeking a Senior Medical Writer to join its regulatory affairs and communications team. You will craft regulatory and scientific documents, including CSRs, regulatory submissions, and publications, ensuring accuracy and compliance.

You should have 5+ years of medical writing experience in pharma/biotech, strong English, and the ability to translate complex data into clear narratives for global audiences. A life sciences background is required.