Senior Medical Writer

• Lead planning and preparation of high-quality clinical regulatory documents
• Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
• Lead document execution, including creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure document development follows client processes, templates, and instructional documents
• Serve as an expert on client document management systems and related tools
• Lead document message development with clients
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate review-feedback resolution and lead comment resolution meetings
• Follow up with team members to resolve outstanding review feedback
• Ensure consistency across client programs in document messaging, formatting, and presentation
• Conduct literature searches as needed
• Perform peer QC reviews as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

• 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field
• Bachelor’s degree or higher in a relevant field
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, Module 2, and Module 5 documents
• Experience writing documents according to established processes and document templates
• Familiarity with lean authoring approaches and structured content management
• Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements desired
• Expertise with Microsoft Word and other Microsoft applications
• Experience with document management systems, collaborative authoring tools, and review tools
• Flexibility to work across multiple therapeutic areas
• Ability to adapt to new tools and technologies
• Ability to work independently and collaboratively amid competing priorities
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Strong written and verbal communication skills
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience with client document management systems and related tools, templates, and procedures
• Legally authorized to work in South Africa

• Full-time, permanent employment arrangement
• Remote work option
• Equal employment opportunity regardless of protected characteristics