Senior Medical Writer

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

📋 Description

• Oversee the planning and creation of top-notch clinical regulatory documents.

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

• Direct document execution and project management duties, which include establishing, updating, 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 a subject matter expert on client document management systems, tools, templates, and procedures.

• Spearhead document messaging development in collaboration with clients.

• Analyze data and create draft documents to assist in the writing process.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and manage comment resolution meetings.

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

• Maintain consistency in messaging, formatting, and presentation across various 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 in the CRO/biotech/pharmaceutical industry.

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

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

• Willingness to work across various therapeutic areas.

• Experience in drafting documents according to established protocols and document templates.

• Familiarity with lean authoring techniques and structured content management.

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

• Proficient in Microsoft Word and other Microsoft applications.

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

• Capability to adapt to new tools and technologies.

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

• A service-oriented and proactive attitude toward project management.

• Skills in conflict resolution and negotiation.

• Strong written and verbal communication abilities.

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

🏝️ 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 law.