(Sr) CSR Narrative Writer

TL;DR

(Sr) CSR Narrative Writer (Oncology): Writing safety documents and patient CSR narratives for regulatory agency submissions with an accent on ICH guideline compliance and advanced MS Word techniques. Focus on leading complex projects, managing document revisions, addressing client comments, and ensuring high-quality deliverables under limited oversight.

Location: South Africa (Remote)

Company

hirify.global is a data-focused CRO supporting pharmaceutical, biotech, and medical device industries with scientific solutions for complex trial data and regulatory submissions, maintaining a global footprint across four continents.

What you will do

• Write safety documents and patient CSR narratives for regulatory submissions.
• Produce high-quality documents compliant with ICH and regulatory guidelines.
• Address client comments, manage revisions, and review deliverables with limited mentor oversight.
• Interact directly and independently with clients.
• Follow hirify.global and sponsor processes while practicing excellent customer service and leadership.

Requirements

• College degree in scientific, medical, or clinical discipline (Master’s or PhD preferred).
• 1-3 years in regulated scientific/clinical, pharmaceutical, biotech, or clinical research environment.
• Experience leading complex CSR narratives projects (Oncology background preferred).
• Prior medical, narrative, or safety writing experience.
• Excellent written English skills, proficient in MS Word and Adobe Acrobat.
• Understanding of ICH guidelines, high organization, attention to detail, and strong communication skills.
• Experience with Electronic Document Management systems.

Culture & Benefits

• Emphasis on enthusiasm, collaboration, teamwork, and diverse global talent pool.
• Focus on identifying top talent, continual training, and strengthening core skills.
• High customer satisfaction (97%) through quality service and technology solutions.