(Sr) Medical Writer (Home Based - South Africa)

Location: Home-based anywhere in South Africa; listed locations include Bloemfontein, Johannesburg, Pretoria, Cape Town, and Durban.

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission services.

What you will do

• Critically evaluate and interpret medical literature to support study design, statistical significance, scientific rigor, and unbiased source selection.
• Write and edit clinical development and regulatory documents, including clinical protocols, investigator’s brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2 documents, presentations, and journal publications.
• Manage writing assignments, timelines, workflows, and delivery under minimal supervision.
• Coordinate independently with clients, project teams, and other departments to gather information and support project execution.
• Contribute to or manage interpretive guides and mentor medical writers and project team members.

Requirements

• At least 5 years of regulatory and clinical medical writing experience, including at least 3 years in the pharmaceutical industry.
• Substantial oncology experience and clinical study protocol experience as a lead author are required.
• Experience leading and managing teams while authoring regulatory documents under aggressive timelines.
• Bachelor’s, master’s, or Ph.D. in a scientific, medical, or clinical discipline is preferred.
• Strong understanding of clinical data, exceptional writing skills, organization, multitasking, and project leadership.
• Expert proficiency with MS Word, Excel, PowerPoint, client templates, and style guides.

Nice to have

• Experience with regulatory submissions, including clinical study reports presented to regulatory authorities.
• Understanding of federal regulations, Good Clinical Practices, and ICH guidelines.
• Experience with orphan drug designations and PSPs/PIPs.

Culture & Benefits

• Home-based work arrangement within South Africa.
• Collaborative and inclusive working environment.
• Opportunity to work with pharmaceutical, biotech, and medical device clients on clinical research programs.
• Full-time position within a global clinical research organization.