Associate Director, R&I Clinical Regulatory Writing (CReW)

Job description preview

From AstraZeneca’s original posting

We are now recruiting an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical delivery or submission team, the Associate Director provides strategic communications leadership to projects, establishes communication standards and best practice, and continuously advocates for quality and efficiency. The Associate Director also authors strategic clinical-regulatory documents and provides critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery. What You will Do The Associate Director, CReW, is expected to: • Independently manage clinical regulatory writing activities across a portfolio of work. • Author clinical-regulatory documents within a program by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied. • Drive the development of the clinical Submission Communication Strategy. • Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality. • Drive the clinical interpretation of complex data and information and condense it into…