Senior Medical Writer (Pharma)

TL;DR

Senior Medical Writer (Clinical Research): Writing and editing clinical development documents for pharmaceutical and biotech industries with an accent on regulatory submission challenges, clinical protocols, and oncology. Focus on critically evaluating medical literature, managing aggressive timelines, and leading teams through complex authoring processes.

Location: Home-based, must be located in South Africa

Company

hirify.global is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with scientific approaches to trial data and regulatory submissions.

What you will do

• Critically evaluate and analyze medical literature to ensure study design scientific rigor and absence of bias.
• Author and edit clinical development documents, including protocols, investigator’s brochures, and clinical study reports.
• Coordinate directly and independently with clients to manage all facets of project delivery.
• Maintain timelines and workflow for various complex writing assignments.
• Mentor other medical writers and project team members involved in the writing process.

Requirements

• Must be based in South Africa.
• Minimum 5 years of industry regulatory and clinical medical writing experience.
• At least 3 years of previous experience in the pharmaceutical industry.
• Degree (Bachelors, Masters, or Ph.D.) in a scientific, medical, or clinical discipline.
• Substantial experience in Oncology and as a lead author for clinical study protocols.
• Expert proficiency in MS Word, Excel, and PowerPoint.

Nice to have

• Experience with orphan drug designations and PSP/PIPs.
• Experience in regulatory submissions presented to regulatory authorities.
• Strong understanding of federal regulations, Good Clinical Practices (GCP), and ICH guidelines.

Culture & Benefits

• Great Place to Work certified organization with an exceptional employee retention rate.
• Collaborative and inclusive work environment with a global footprint.
• Flexible home-based work arrangement.
• Supportive team culture focused on professional advancement.