Clinical Regulatory Writer (Associate Director or Manager)

Job description

Job Title: Clinical Regulatory Writer, Associate Director or Manager Location: Boston, MA - Hybrid (3 days onsite) Introduction to role: Are you ready to be part of the solution, turning drug development strategies into reality? As a Clinical Regulatory Writer, you will play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities: As a Clinical Regulatory Writer, you will: Independently manage clinical regulatory writing activities across a complex portfolio of work. Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met. Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency. Drive the development of the clinical Submission...