CReW leads the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB, in line with the project communication strategy, and ensure quality and efficiency in delivery
Job Summary
CReW leads the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB, in line with the project communication strategy, and ensure quality and efficiency in delivery.
For CSP/MICF/IB, CReW centralize and coordinate those developments using external vendors across clinical studies.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
Matching Summary
CReW leads the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB, in line with the project communication strategy, and ensure quality and efficiency in delivery.
Skills & Requirements
Must-have
Authoring clinical-regulatory documents
Drug development processes
Key regulations/guidelines (GCP, ICH GLs)
Medical writing skill
Logical thinking/Presentation skill
Interpersonal and communication skills
Facilitation skill
Nice-to-have
Leading preparation of clinical documentation
Regulatory submissions (CTN, JNDA/sJNDA)
Response to PMDA/MHLW queries
Supervising internal communications
Outsourced writing experience
Digital tools and technologies
Key Requirements
Medical Writing Skill/Experience
Knowledge of drug development processes and regulations
Bachelor’s Degree in Science or related discipline