
Senior Clinical Document Specialist
3 days ago
Regulatory Medical Writer Position
">We are seeking an experienced regulatory medical writer to join our team at either a senior or junior level. You can work remotely from anywhere in Australia.
">Job Overview">The successful candidate will be responsible for coordinating, writing, and editing clinical documents including investigator brochures, clinical study protocols, participant information forms, and clinical study reports. They will also serve as a primary technical contact for other departments and clients, mentor junior writers, and uphold quality standards.
">Main Responsibilities:
">- Coordinating, writing, and editing clinical documents
- Serving as a primary technical contact for other departments and clients
- Mentoring junior medical writers
- Upholding quality standards
Required Skills and Qualifications:
">- Bachelor's degree in a scientific or relevant discipline
- Higher degree (desirable)
- At least 2 years of medical writing experience, including clinical trial documents
- Minimum 3 years in the biotech/pharma/clinical research industry
- Strong report writing skills and experience with peer-reviewed publications
- Knowledge of ICH GCP, ICH E3 guidelines, medical terminology, and clinical trial processes
- Knowledge of statistics and data analysis (desirable)
- Knowledge of pharmacokinetics (desirable)
Benefits:
">We offer a supportive employee-centric culture with excellent long-term career prospects. We promote work-life balance with options for 100% remote work and hybrid arrangements.
"] ,-
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