Remote Principal Medical Writer: Regulatory Submissions

Placements24; Pretoria; Hybrid; ZAR 1,500,000 - 2,000,000; Full time

Benefits offered by this job

Fully remote

Medical insurance

Dental insurance

Vision insurance

Generous vacation

Professional development

Job summary

Placements24 is seeking a Principal Medical Writer to lead the development of regulatory documents from home within South Africa. You will mentor junior writers and drive high-quality submissions across INDs, NDAs, and CTDs.

Responsibilities include coordinating cross-functional teams, ensuring scientific accuracy, and maintaining global regulatory standards. A Master’s or PhD in life sciences and 8–10 years of pharma experience are required.

Qualifications

• Master's degree or PhD in life science or related field.
• 8–10 years' medical writing experience in pharma/biotech focusing on regulatory documents.
• Proven ability to write regulatory submission documents (INDs, NDAs, CTDs).
• Strong knowledge of ICH guidelines and global submission requirements.
• Excellent writing, editing, proofreading, and attention to detail.
• Ability to interpret and synthesize complex data.
• Strong project management and ability to meet deadlines.
• Excellent communication, remote collaboration.
• MS Office and document management familiarity.

Responsibilities

• Lead the preparation of regulatory documents (IBs, protocols, CSRs, CTDs).
• Ensure documents are scientifically accurate and compliant with guidelines.
• Collaborate with cross-functional teams in regulatory affairs and development.
• Review and edit documents authored by teammates.
• Contribute to internal style guides and templates.
• Manage multiple projects with timely delivery.

Skills

Regulatory writing

Clinical data interpretation

Document management

Education

Master's degree

PhD

Tools

MS Office

Document management systems

Job description

Placements24 is seeking a Principal Medical Writer to lead the development of regulatory documents from home within South Africa. You will mentor junior writers and drive high-quality submissions across INDs, NDAs, and CTDs.

Responsibilities include coordinating cross-functional teams, ensuring scientific accuracy, and maintaining global regulatory standards. A Master’s or PhD in life sciences and 8–10 years of pharma experience are required.