Senior Medical Writer

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Oversee the planning and preparation of high-quality clinical regulatory documents.

• Create protocols, publications, study reports, investigator brochures, narratives, and module documents.

• Manage document execution and project timelines, ensuring effective communication and maintenance.

• Coordinate contributions from cross-functional clients, stakeholders, and internal resources, including quality control and publishing.

• Ensure adherence to client processes, templates, and instructional documents in all documents.

• Act as an authority on client document management systems, tools, templates, and procedures.

• Lead the development of document messaging in collaboration with clients.

• Analyze data and produce shell documents.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and conduct meetings for comment resolution.

• Follow up with team members to address any outstanding review feedback.

• Maintain consistency in messaging, formatting, and document presentation across client programs.

• Conduct literature searches when necessary.

• Perform peer quality-control reviews as required.

• Contribute to medical writing operational initiatives, including templates, style guides, and reference management.

⛳️ Requirements

• A minimum of 5 years of experience as a medical writer within the CRO, biotech, or pharmaceutical sector.

• A bachelor’s degree or higher in a relevant discipline.

• Experience in Oncology, Infectious Disease, or Vaccine development is preferred.

• Background in writing clinical study reports, protocols, protocol amendments, investigator brochures, and module 2 and module 5 documents is desirable.

• Flexibility to work across various therapeutic areas.

• Proven experience in writing documents according to established processes and templates.

• Familiarity with lean authoring methods and structured content management.

• Knowledge of ICH and US regulatory requirements; familiarity with ex-US regulatory requirements is a plus.

• Proficient in Microsoft Word and other Microsoft applications.

• Experience with document management systems, collaborative authoring tools, and review platforms.

• Ability to adapt to new technologies and tools.

• Capability to work both independently and collaboratively while managing competing priorities.

• A service-oriented and proactive approach to project management.

• Strong conflict management and negotiation abilities.

• Excellent written and verbal communication skills.

• Must be based in South Africa and legally authorized to work in the country.

🏝️ Benefits

• Full-time, permanent employment arrangement.

• Option for remote work.

• Equal employment opportunity regardless of protected characteristics.