Clinical Regulatory Writer (CReW) is responsible for authoring clinical-regulatory documents that communicate product knowledge credibly and compliantly
Job Summary
Clinical Regulatory Writer (CReW) is responsible for authoring clinical-regulatory documents that communicate product knowledge credibly and compliantly.
CReW leads the authoring of clinical parts of documents such as CSP, MICF, CSR, and IB in line with project communication strategies, ensuring quality and efficiency.
AstraZeneca embraces diversity and equality of opportunity and is committed to building an inclusive and diverse team representing all backgrounds.
Matching Summary
Clinical Regulatory Writer (CReW) is responsible for authoring clinical-regulatory documents that communicate product knowledge credibly and compliantly.
Skills & Requirements
Must-have
Medical writing skill
Knowledge of drug development regulations
Logical thinking and presentation skills
Interpersonal and communication skills
Facilitation skill in discussions
Nice-to-have
Experience leading clinical regulatory documentation
Experience with regulatory submissions and PMDA/MHLW queries
Supervising internal and outsourced writing
Experience with digital tools in medical writing
Key Requirements
Bachelor’s Degree in Science or related discipline
Medical Writing Skill/Experience
Comprehensive knowledge of drug development processes including GCP and ICH guidelines