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.

• Direct document execution, which includes establishing, maintaining, and communicating timelines.

• Coordinate contributions from cross-functional client teams, stakeholders, and internal resources such as quality control and publishing.

• Ensure that document development adheres to client processes, templates, and instructional guidelines.

• Act as an authority on client document management systems and associated tools.

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

• Analyze data and develop shell documents to facilitate authorship.

• Organize and lead kickoff meetings.

• Manage review-feedback resolution and conduct comment resolution meetings.

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

• Ensure uniformity across client programs in terms of document messaging, formatting, and presentation.

• Conduct literature searches as necessary.

• Execute peer quality control reviews as required.

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

⛳️ Requirements

• Minimum of 5 years of experience as a medical writer in the CRO/biotech/pharmaceutical sectors.

• Bachelor’s degree or higher in a relevant discipline.

• Proven experience in drafting clinical study reports, protocols, protocol amendments, investigator brochures, Module 2, and Module 5 documents.

• Experience in writing documents that comply with established processes and templates.

• Familiarity with lean authoring methodologies and structured content management.

• Understanding of ICH and US regulatory requirements; knowledge of ex-US regulatory requirements is a plus.

• Proficiency in Microsoft Word and other Microsoft applications.

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

• Ability to work flexibly across various therapeutic areas.

• Capability to adapt to new tools and technologies.

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

• Service-oriented and proactive approach to project management.

• Strong conflict management and negotiation skills.

• Excellent written and verbal communication skills.

• Experience in Oncology, Infectious Disease, or Vaccines is preferred.

• Familiarity with client document management systems, associated tools, templates, and procedures.

• Legally authorized to work in South Africa.

🏝️ Benefits

• Full-time, permanent employment opportunity.

• Option for remote work.

• Equal employment opportunity regardless of protected characteristics.