Remote Medical Writer — Regulatory Dossiers & CTD Expert

Placements24; LegKraal Gate; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Remote work

Home office support

Paid time off

Professional development

Job summary

Placements24 is seeking a skilled Medical Writer to craft regulatory documentation for submissions from a remote work environment near Mahikeng. You will translate complex clinical data into clear, compliant dossiers and collaborate with medical, clinical, and regulatory teams to ensure accuracy and completeness.

The role demands exceptional writing, deep regulatory knowledge, and the ability to work independently while coordinating with teams located nearby Mahikeng.

Qualifications

• Advanced degree in life sciences or related field.
• Minimum of 4 years experience as a Medical Writer.
• Experience preparing regulatory submission documents.

Responsibilities

• Write, edit, and review regulatory documents (IBs, CSRs, CTD modules).
• Ensure documents are scientifically accurate and compliant with ICH guidelines.
• Collaborate with SMEs to gather information and ensure integrity of documents.
• Manage development timelines and coordinate review cycles with stakeholders.
• Maintain high clarity, grammar, and consistency in all communications.
• Stay updated on regulatory requirements and best practices.

Skills

Medical writing

Regulatory documents

Editing

Regulatory guidelines

Education

Advanced degree (MS/PhD/PharmD/MD)

Tools

MS Word

Adobe Acrobat

EndNote

Job description

Placements24 is seeking a skilled Medical Writer to craft regulatory documentation for submissions from a remote work environment near Mahikeng. You will translate complex clinical data into clear, compliant dossiers and collaborate with medical, clinical, and regulatory teams to ensure accuracy and completeness.

The role demands exceptional writing, deep regulatory knowledge, and the ability to work independently while coordinating with teams located nearby Mahikeng.