Remote Lead Medical Writer: Clinical Study Reports

Placements24; East London; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Remote work flexibility

Professional development

Job summary

Placements24 is seeking a Lead Medical Writer with CSR expertise for a fully remote role with a global pharmaceutical client. You will lead planning, writing, and completion of CSRs and regulatory documents, guiding junior writers and ensuring regulatory compliance.

This senior position requires an advanced degree, 7+ years in medical writing, proficiency with ICH E3, and strong leadership. You will collaborate across clinical operations, biostatistics, regulatory affairs, and project

Qualifications

• Advanced degree in life/health sciences (Master's or PhD).
• Minimum 7 years of medical writing experience in pharma/biotech focusing on CSRs and regulatory documents.
• Expertise in writing complex CSRs per ICH E3 guidelines.
• Strong understanding of clinical trial design, conduct, data analysis and reporting.
• Excellent written and verbal communication with meticulous attention to grammar.
• Proven ability to manage multiple projects and meet deadlines in a remote setting.
• Strong collaboration and leadership skills.
• Proficiency with relevant software and document management systems.

Responsibilities

• Lead the writing and finalization of CSRs, IBs, protocols, and other regulatory submissions.
• Ensure all deliverables are scientifically accurate, clear, and compliant with regulatory guidelines.
• Manage timelines and resources for medical writing projects to ensure timely delivery.
• Collaborate with cross-functional teams (clinical operations, biostatistics, regulatory affairs, PM).
• Review and edit documents written by junior writers and external vendors.
• Mentor junior writers and provide training to improve skills.
• Contribute to development and continuous improvement of writing processes and templates.
• Stay updated on regulatory requirements and scientific advances.

Skills

CSR writing

Regulatory writing

ICH E3

Clinical trial design

Leadership

Education

Master's or PhD in life/health sciences

Tools

Document management systems

Job description

Placements24 is seeking a Lead Medical Writer with CSR expertise for a fully remote role with a global pharmaceutical client. You will lead planning, writing, and completion of CSRs and regulatory documents, guiding junior writers and ensuring regulatory compliance.

This senior position requires an advanced degree, 7+ years in medical writing, proficiency with ICH E3, and strong leadership. You will collaborate across clinical operations, biostatistics, regulatory affairs, and project