Senior Medical Writer: Regulatory Documents Lead

Transperfect; Cape Town; On-site; ZAR 900,000 - 1,200,000; Full time

Job summary

TransPerfect is seeking an organized medical writer to support planning and preparation of clinical regulatory documents across Oncology, Infectious Disease, or Vaccines. The role partners with Clinical Development, Biostatistics, Regulatory, and Program Management to deliver protocols, study reports, investigator brochures, and module documents within tight timelines.

You'll lead document execution, coordinate cross-functional contributors, and ensure adherence to client processes and

Qualifications

• 5+ years experience as a medical writer in CRO/biotech/pharma
• Bachelor’s degree or higher in a relevant field
• Experience writing clinical study reports, protocols, investigator brochures, module 2 and 5 documents
• Familiarity with ICH and US regulatory requirements

Responsibilities

• Lead execution of documents and manage timelines
• Coordinate cross-functional contributors and internal resources
• Ensure templates and client processes are followed
• Serve as an expert on client document management systems
• Lead document message development with clients
• Interpret data and create shell documents for authoring
• Plan and lead kickoff meetings
• Address review feedback and drive comment resolution meetings
• Ensure consistency across client programs in messaging and formatting
• Conduct literature searches as needed
• Perform peer QC reviews as needed
• Contribute to operational writing initiatives if needed

Skills

Medical writing

Project management

Literature search

Quality control

Cross-functional collaboration

Microsoft Word

Document management systems

Education

Bachelor’s degree or higher

Tools

Microsoft Word

Document management systems

Collaborative authoring tools

Review tools

Job description

TransPerfect is seeking an organized medical writer to support planning and preparation of clinical regulatory documents across Oncology, Infectious Disease, or Vaccines. The role partners with Clinical Development, Biostatistics, Regulatory, and Program Management to deliver protocols, study reports, investigator brochures, and module documents within tight timelines.

You'll lead document execution, coordinate cross-functional contributors, and ensure adherence to client processes and