Senior Medical Writer - Pharmaceutical

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

About the Role

Our client is seeking a highly skilled Senior Medical Writer to join their expanding regulatory affairs and communications team in Kimberley . This crucial role involves crafting clear, accurate, and compliant regulatory and scientific documents that support drug development and registration globally. You will be responsible for producing a wide range of documents, including clinical study reports, regulatory submission documents, and scientific publications. The ideal candidate possesses exceptional writing abilities, a thorough understanding of pharmaceutical sciences, and the expertise to translate complex scientific data into accessible and compelling narratives for diverse audiences.

Key Responsibilities

• Author, edit, and review a variety of regulatory and scientific documents, including Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Ensure all documents meet regulatory requirements (e.g., ICH, FDA, EMA, SAHPRA) and internal style guidelines.
• Collaborate closely with clinical development, regulatory affairs, biostatistics, and medical affairs teams to gather information and ensure accuracy.
• Manage document timelines and deliverables effectively, coordinating input from multiple contributors.
• Contribute to the development of medical communication strategies and publication plans.
• Maintain up-to-date knowledge of therapeutic areas, regulatory guidelines, and medical writing best practices.

Requirements

• Bachelor's or Master's degree in a life science, pharmacy, medicine, or a related field.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated experience in writing clinical study reports and regulatory submission documents.
• Excellent command of English language, grammar, and scientific terminology.
• Proficiency with Microsoft Office Suite and experience with document management systems.
• Strong understanding of drug development processes and regulatory requirements is critical for success in this role in Kimberley .

Benefits

• Competitive salary commensurate with experience.
• Comprehensive health, dental, and vision insurance benefits.
• Generous paid time off and holidays.
• Opportunities for professional development and continuing education.
• Flexible remote work arrangements offering excellent work-life balance.