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
Job Summary
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.
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
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.
Skills & Requirements
Must-have
Medical writing skill
Drug development processes knowledge
Key regulations/guidelines knowledge
Logical thinking and presentation skill
Interpersonal and communication skills
Facilitation skill for innovative solutions
Nice-to-have
Significant medical writing experience
Leading clinical regulatory documentation
Regulatory submissions delivery
Supervising internal and outsourced writing
Digital tools and technologies in medical writing
Key Requirements
Medical Writing Skill/Experience
Bachelor’s Degree in Science or related discipline