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.

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documentation.

• Direct document execution and project management activities, including the creation, maintenance, and communication of timelines.

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

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

• 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 to aid in authoring.

• Organize and lead kickoff meetings.

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

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

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

• Conduct literature searches when necessary.

• Perform peer quality control reviews as needed.

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

⛳️ Requirements

• A minimum of 5 years of experience as a medical writer in the CRO/biotech/pharmaceutical sector.

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

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

• Prior experience in writing clinical study reports, protocols, protocol amendments, investigator brochures, and module 2 and module 5 documents is desired.

• Ability to work flexibly across various therapeutic areas.

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

• Knowledge of lean authoring practices and structured content management.

• Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory standards is a plus.

• Expertise in Microsoft Word and other Microsoft applications.

• Experience in developing documents using document management systems, collaborative authoring tools, and review platforms.

• Capability to adapt to new tools and technologies.

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

• A service-oriented and proactive mindset towards project management.

• Strong conflict management and negotiation skills.

• Excellent written and verbal communication abilities.

• Must reside in South Africa and be legally authorized to work in South Africa, as specified in the application question.

🏝️ Benefits

• Equal employment opportunity without regard to race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local laws.