About this role

Responsible for the authoring of clinical-regulatory documents that communicate the evidence base of product knowledge in a credible, consistent and compliant way.
Lead the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB, in line with the project communication strategy
Ensure quality and efficiency in delivery.
Centralize and coordinate developments using external vendors across clinical studies.

Medical Writing Skill/Experience
A comprehensive knowledge of the drug development processes including key regulations/guidelines(e.g. GCP, ICH GLs)
Significant medical writing experience in pharmaceuticals industry
Experience in leading the preparation of clinical regulatory documentation at the development strategy level.
Delivery of regulatory submissions including CTN, JNDA/sJNDA and response to PMDA/MHLW queries during review
Experience in supervising internal communications and outsourced writing.
Experience with digital tools and technologies in medical writing.
Bachelor’s Degree in Science or related discipline
Japanese: Native level
English: Reading & Writing

AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds.
Harnessing industry-leading skills.
Lifelong learning, growth and development for all.

Clinical Regulatory Writer, 研究開発本部薬事統括部薬事オペレーション部クリニカルレギュラトリーライティングスタディドキュメントグループ

Key skills