CSR Narrative Writer - Project Based (South Africa, Remote)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
CSR Narrative Writer (Project Based): Writing patient CSR narratives and safety documents for regulatory submissions with an accent on compliance with ICH guidelines and oncology background. Focus on managing document revisions, addressing client comments, and producing high-quality deliverables with limited oversight.
Location: Remote from South Africa
Company
is an innovative data-focused CRO supporting pharmaceutical, biotech, and medical device industries with scientific solutions for trial data and regulatory submissions.
What you will do
- Write safety documents and patient CSR narratives for regulatory agency submissions.
- Address client comments, manage revisions, and review deliverables with limited mentor oversight.
- Ensure compliance with ICH and regulatory guidelines.
- Interact directly and independently with clients.
- Follow and sponsor processes while practicing excellent customer service.
Requirements
- Remote from South Africa.
- Experience leading complex CSR narratives projects, preference for oncology background.
- College graduate in scientific, medical, or clinical discipline (Master’s or PhD preferred).
- 2-3 years in regulated scientific/clinical, pharmaceutical, biotech, or clinical research environment.
- 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
- Project-based up to 40 hours per week until end of June 2026.
- Global and diverse talent pool fostering enthusiasm, collaboration, and teamwork.
- Focus on continual training to strengthen core skills.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →