Senior Medical Writer

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

📋 Description

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

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

• Direct document execution by 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 the client document management system, along with associated tools, templates, and procedures.

• Guide document message formulation in collaboration with the client.

• Analyze data and create shell documents to aid in the authoring process.

• Organize and lead kickoff meetings.

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

• Follow up with team members to address remaining review feedback.

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

• Perform literature searches as required.

• Conduct peer quality control reviews as necessary.

• Participate in 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 sectors.

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

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

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

• Willingness to work across various therapeutic areas, if necessary.

• Proficiency in authoring documents following established processes and templates.

• Familiarity with lean authoring techniques and structured content management practices.

• Understanding of the requirements for key clinical and regulatory documents, including ICH and US regulatory standards.

• A working knowledge of ex-US regulatory requirements is preferred.

• High proficiency in Microsoft Word and other Microsoft applications.

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

• Ability to adapt to new tools and technologies as needed.

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

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

• Excellent skills in conflict management and negotiation.

• Comfortable providing insights based on past experiences.

• Strong written and verbal communication abilities.

• Must reside in South Africa and be legally authorized to work in South Africa.

🏝️ Benefits

• 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.