Medical Writer - Clinical Study Reports

Placements24; Kimberley; Hybrid; CAD 70,000 - 110,000; Full time

Benefits offered by this job

Fully remote

Professional development

Work–life balance

Job summary

Placements24 is seeking a highly skilled Medical Writer to focus on clinical study reports (CSRs) for our pharmaceutical client. This remote role involves authoring clear, accurate CSRs based on trial data and ensuring regulatory compliance for submissions.

You will interpret complex data, collaborate with biostatisticians, prepare related documents (IBs, protocols, study summaries), and manage multiple projects with tight deadlines while working independently from anywhere.

Qualifications

• Bachelor's or Master's in life science, healthcare, or related field.
• Minimum of 5 years as a Medical Writer with a focus on CSRs.
• Thorough understanding of ICH guidelines (especially E3) and regulatory submissions.
• Proven ability to interpret clinical data and translate it into clear reports.
• Experience working remotely and managing projects independently.

Responsibilities

• Author CSRs per ICH guidelines and regulatory requirements.
• Interpret trial data with biostatisticians to ensure accuracy.
• Prepare Investigator's Brochures, protocols, and study summaries.
• Ensure consistency in medical terminology across documents.
• Review and edit colleagues' documents and provide feedback.
• Manage multiple writing projects and meet deadlines.

Skills

Medical writing

Data interpretation

Editing & proofreading

Regulatory knowledge (ICH)

Remote work

Education

Bachelor's or Master's in life science/healthcare

Job description

About the Role

Our client is seeking a highly skilled and experienced Medical Writer to focus on clinical study reports (CSRs) for their pharmaceutical research division. In this critical role, you will be responsible for authoring clear, accurate, and compliant CSRs based on clinical trial data. Your expertise will ensure that trial results are communicated effectively to regulatory agencies and the scientific community, supporting the drug development process. This remote position offers the flexibility to work from anywhere while contributing to significant advancements in medicine.

Key Responsibilities

• Author comprehensive Clinical Study Reports (CSRs) in accordance with ICH guidelines and regulatory requirements.
• Interpret clinical trial data and collaborate with biostatisticians and study team members to ensure accuracy.
• Prepare other regulatory documents, such as Investigator's Brochures, protocols, and study summaries.
• Ensure consistency in medical and scientific terminology across all documentation.
• Review and edit documents written by other team members, providing constructive feedback.
• Manage multiple writing projects simultaneously, meeting strict deadlines.

Requirements

• Bachelor's or Master's degree in a life science, healthcare, or a related field.
• Minimum of 5 years of experience as a Medical Writer, with a strong focus on authoring CSRs.
• Thorough understanding of ICH guidelines (especially E3 for CSRs) and regulatory submission requirements.
• Proven ability to interpret complex clinical data and translate it into clear, concise written reports.
• Exceptional writing, editing, and proofreading skills.
• Experience working in a remote environment and managing projects independently.

Benefits

• Competitive salary and potential for performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday schedule.
• Fully remote work arrangement allowing for excellent work-life balance.
• Opportunities for professional development and skill enhancement.
• Collaborative team environment with supportive colleagues.