Senior Medical Writer

Placements24; Kimberley; On-site; CAD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Bonus opportunities

Medical, dental, vision insurance

Retirement savings plan

Continuing education

Job summary

Our client in Kimberley, Canada seeks a Senior Medical Writer to join their medical affairs team. You will create, edit, and manage a range of regulatory, scientific, and educational documents for health authorities, professionals, and patients, ensuring accuracy and compliance across ICH, FDA, and EMA guidelines.

You will mentor junior writers, coordinate with R&D, regulatory, and clinical operations, and oversee timelines and budgets for multiple projects in a demanding environment.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Minimum of 5 years of experience as a Medical Writer in pharma/biotech.
• Ability to write and edit complex scientific and medical documents for diverse audiences.
• In-depth knowledge of clinical trial processes, regulatory submission requirements, and scientific publication standards.
• Excellent organizational, project management, and communication skills.
• Proficiency in MS Office and familiarity with document management systems.

Responsibilities

• Write, edit, and review CSRs, investigator brochures, regulatory submission documents, manuscripts, and abstracts.
• Ensure documents are scientifically accurate, clearly written, and comply with guidelines (ICH, FDA, EMA) and company standards.
• Collaborate with R&D, clinical ops, regulatory affairs, and marketing to gather information and ensure alignment.
• Manage document development timelines and budgets for timely completion.
• Stay current with therapeutic area advancements, regulatory requirements, and best practices in medical writing.
• Mentor junior medical writers and contribute to internal style guides and templates.

Skills

Medical writing

Regulatory writing

Project management

Communication

Mentoring

Education

Bachelor's degree in life sciences

Master's or PhD preferred

Tools

Microsoft Office

Document management systems

Job description

About the Role

Our client is seeking an experienced and highly skilled Senior Medical Writer to join their medical affairs department in Kimberley . This role is essential for creating clear, accurate, and scientifically sound documents that communicate complex medical and scientific information effectively. You will be responsible for developing a range of regulatory, scientific, and educational documents for various audiences, including health authorities, healthcare professionals, and patients. The ideal candidate possesses exceptional writing skills, a deep understanding of pharmaceutical research and development, and the ability to manage multiple projects simultaneously in a demanding environment. This is a vital role in ensuring effective communication of medical data and supporting regulatory submissions and scientific exchange.

Key Responsibilities

• Write, edit, and review a variety of medical documents, including clinical study reports (CSRs), investigator brochures, regulatory submission documents, manuscripts, and abstracts.
• Ensure all documents are scientifically accurate, clearly written, and comply with relevant guidelines (e.g., ICH, FDA, EMA) and company standards.
• Collaborate closely with cross-functional teams, including R&D, clinical operations, regulatory affairs, and marketing, to gather information and ensure alignment.
• Manage document development timelines and budgets to ensure timely completion of projects.
• Stay current with therapeutic area advancements, regulatory requirements, and best practices in medical writing.
• Mentor junior medical writers and contribute to the development of internal style guides and templates.

Requirements

• Bachelor's degree in a life science, health science, or related field; advanced degree (Master's or Ph.D.) preferred.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven ability to write and edit complex scientific and medical documents for diverse audiences.
• In-depth knowledge of clinical trial processes, regulatory submission requirements, and scientific publication standards.
• Excellent organizational, project management, and communication skills.
• Proficiency in Microsoft Office Suite and familiarity with document management systems.

Benefits

• Competitive annual salary and performance-based bonus opportunities.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off and retirement savings plan.
• Support for continuing education and professional development.
• Opportunity to work on important medical and regulatory documents in Kimberley.