Senior Medical Writer: CSR & Regulatory Submissions

Placements24; Cape Town; Presencial; ZAR 900.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Comprehensive benefits package

Professional development and training

Collaborative work environment

Exposure to cutting-edge R&D

Descripción de la vacante

Placements24 is seeking a highly skilled Medical Writer to join the regulatory affairs team in Kimberley. You will author and finalize CSRs, protocols, IBs, and study plans for clinical development, ensuring accuracy and regulatory compliance.

You will collaborate with clinical operations, biostatistics, and regulatory groups to deliver high-quality documentation under tight timelines in a fast-paced pharma environment.

Formación

• Advanced degree in life sciences (Master’s or PhD).
• Experience as Medical Writer in pharma/biotech for 4+ years.
• Strong experience in writing clinical/regulatory documents, esp. CSRs.
• Solid knowledge of ICH guidelines and regulatory processes.
• Excellent written and verbal communication, detail-oriented.

Responsabilidades

• Author, edit, and finalize CSRs for Phase I–IV trials.
• Develop and maintain protocols, IBs, and study plans.
• Prepare responses to regulatory questions and contribute to submissions.
• Ensure outputs are scientifically accurate and regulatorily compliant.
• Collaborate with cross-functional teams to gather information and meet deadlines.
• Review others' work for accuracy and consistency.

Conocimientos

Medical writing

Regulatory writing

CSR writing

Educación

MSc in life sciences

PhD in life sciences

Descripción del empleo

Placements24 is seeking a highly skilled Medical Writer to join the regulatory affairs team in Kimberley. You will author and finalize CSRs, protocols, IBs, and study plans for clinical development, ensuring accuracy and regulatory compliance.

You will collaborate with clinical operations, biostatistics, and regulatory groups to deliver high-quality documentation under tight timelines in a fast-paced pharma environment.