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 the client document management system and related tools, templates, and procedures
• Lead document message development with the client
• 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 in messaging, formatting, and presentation across client programs
• 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

• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
• Bachelor’s degree or higher in a relevant field
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents desired
• Flexibility to work across multiple therapeutic areas, if needed
• Experience writing documents according to established processes and document templates
• Familiarity with lean authoring approaches and structured content management
• Familiarity with requirements for key clinical and regulatory documents, including ICH and US regulatory requirements
• Working knowledge of ex-US regulatory requirements desired
• Expertise with Microsoft Word and other Microsoft applications
• Experience developing documents using document management systems, collaborative authoring tools, and review tools
• Comfortable adapting to new tools and technologies, if needed
• Ability to work independently and collaboratively amid competing priorities
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based on previous experience
• Strong written and verbal communication skills
• Must be based in South Africa and legally authorized to work in South Africa

• Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law