Remote Medical Writer - CSRs & Regulatory Docs

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 360,000 - 600,000; Full time

Benefits offered by this job

Competitive salary

Fully remote

Health, dental & vision insurance

Professional development

Collaborative virtual team

Job summary

Placements24 is seeking a skilled Medical Writer to produce high-quality CSRs and regulatory documents in a fully remote setting. You will collaborate with clinical operations, biostatistics, and regulatory affairs to ensure accuracy and regulatory compliance, supporting submissions and written scientific communications.

The role requires a Life Sciences or related degree, at least 3 years of medical writing experience, and strong knowledge of ICH guidelines.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree is a plus.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proven ability to write clear, concise, and scientifically accurate documents, especially CSRs.
• Thorough understanding of clinical trial processes, ICH guidelines, and regulatory submission requirements.
• Excellent written communication skills, strong attention to detail, and proficiency in medical terminology.

Responsibilities

• Author comprehensive Clinical Study Reports (CSRs) based on clinical trial data and statistical analysis.
• Prepare other regulatory documents, including Investigator's Brochures (IBs), protocols, and safety narratives.
• Ensure all medical writing outputs meet the required scientific standards, regulatory guidelines, and company SOPs.
• Collaborate with subject matter experts to ensure scientific accuracy and completeness of documentation.
• Manage multiple writing projects simultaneously, adhering to strict timelines and quality standards in a remote setting.

Skills

Medical writing

Regulatory writing

ICH guidelines

Attention to detail

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

Job description

Placements24 is seeking a skilled Medical Writer to produce high-quality CSRs and regulatory documents in a fully remote setting. You will collaborate with clinical operations, biostatistics, and regulatory affairs to ensure accuracy and regulatory compliance, supporting submissions and written scientific communications.

The role requires a Life Sciences or related degree, at least 3 years of medical writing experience, and strong knowledge of ICH guidelines.