Senior Medical Writer - Remote, Regulatory & CSR Expert

Placements24; Bloemfontein; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Home office allowance

Professional development

Flexible hours

Job summary

Placements24 is seeking a Senior Medical Writer for a fully remote role. You will craft regulatory and scientific documents (CSRs, IBs, protocols) for pharmaceutical and biotech clients, collaborating with international teams while ensuring ICH-GCP compliance and high-quality output.

You will mentor junior writers, manage timelines, and contribute to templates, SOPs, and writing best practices in a remote setting.

Qualifications

• 5+ years in medical writing within CRO/pharma/biotech.
• Experience drafting CSR/IBs/protocols and regulatory submissions.
• Strong knowledge of ICH-GCP and regulatory processes.

Responsibilities

• Author, edit and review CSRs, IBs, protocols, and submission documents.
• Ensure documents are accurate, ethical and regulatory compliant.
• Collaborate with cross-functional teams to gather information and ensure accuracy.
• Manage document production timelines and on-time delivery of high-quality documents.
• Develop and maintain company templates, style guides and SOPs for medical writing.
• Stay updated with literature, therapies, and regulatory requirements.
• Mentor junior writers and review peers' work for quality and consistency.
• Participate in client meetings and contribute to documentation planning.

Skills

Medical writing

Regulatory writing

ICH-GCP

Documentation management

Strong communication

Education

Master's/PhD in Life Sciences/Medicine/Pharmacy

Tools

Document management systems

Job description

Placements24 is seeking a Senior Medical Writer for a fully remote role. You will craft regulatory and scientific documents (CSRs, IBs, protocols) for pharmaceutical and biotech clients, collaborating with international teams while ensuring ICH-GCP compliance and high-quality output.

You will mentor junior writers, manage timelines, and contribute to templates, SOPs, and writing best practices in a remote setting.