AstraZenecaR&DClinical Regulatory Writer (CReW),
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Job Summary
職務内容 Job Description
Clinical Regulatory Writer (CReW) is responsible for the authoring of clinical-regulatory documents that communicate the evidence base of product knowledge in a credible consistent and compliant way.
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.
Requirements
経験 Experience
<必須 Mandatory>
Medical Writing Skill/Experience
A comprehensive knowledge of the drug development processes including key regulations/guidelines(e.g. GCP ICH GLs) and knowledge on a need to know basis in relevant therapeutic area
<歓迎 Nice to have>
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.
資格 License
<必須 Mandatory>
Bachelors Degree in Science or related discipline
能力 Skill-set
<必須 Mandatory>
Medical writing skill
Logical thinking/Presentation skill to express intention in an efficient way in Japanese & English
Interpersonal and communication skills with team member or stakeholders
Facilitation skill to lead an innovative solution in conflicting discussion
語学 Languages
<必須 Mandatory>
日本語 JapaneseNative level
英語 EnglishReading & Writing
Date Posted
01-4月-2026Closing Date
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. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Key Skills
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
