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.

• Collaborate across various functions, including Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management teams.

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

• Direct document execution and project management activities, which include establishing, monitoring, and communicating timelines.

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

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

• Act as a specialist in client document management systems, tools, templates, and procedures.

• Guide the development of document messaging with clients.

• Analyze data and create draft documents.

• Organize and lead kickoff meetings.

• Manage the review-feedback process and facilitate comment resolution meetings.

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

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

• Conduct literature searches as required.

• Perform peer quality-control reviews when necessary.

• Participate in medical writing operational initiatives including templates, style guides, and reference management.

⛳️ Requirements

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

• A bachelor's degree or higher in a relevant field.

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

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

• Flexibility to work across multiple therapeutic areas as necessary.

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

• Familiarity with lean authoring techniques and structured content management.

• Knowledge of key clinical and regulatory document requirements, including ICH and US regulations.

• Working knowledge of regulatory requirements outside the US is preferred.

• Proficient in Microsoft Word and other Microsoft applications.

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

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

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

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

• Strong conflict resolution and negotiation skills.

• Comfortable making suggestions based on prior experience.

• Excellent written and verbal communication skills.

• Applicants based in South Africa must be legally authorized to work in the country.

🏝️ 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.