Job Title: Associate Director - Clinical Regulatory Writing
Job ID: R-215854
Date Posted: 01/13/2025
Career Level: E
Employer: AstraZeneca
At AstraZeneca, we’re pushing the boundaries of science and transforming drug development. As an Associate Director in Clinical Regulatory Writing, you will lead communications expertise across clinical drug programs, authoring critical regulatory documents and guiding strategic initiatives that ensure successful submissions and approvals. This is a high-impact, solutions-driven role, contributing to the global success of life-changing medicines.
AstraZeneca is a great place to work, offering an environment where you are empowered to drive innovation. We are committed to lifelong learning, growth, and development. At AstraZeneca, you'll be part of an inclusive culture that champions diversity and collaboration, all while making a meaningful difference to medicine, patients, and society.
The Clinical Regulatory Writing team is a diverse group focused on accelerating drug development. We leverage expertise from across AstraZeneca’s Therapy Areas to deliver rapid global approvals, bringing new medicines to patients. Our goal is to lead with communication excellence and ensure high-quality regulatory submissions across all phases of clinical development.
Leadership in Clinical Regulatory Writing:
Independently manage and lead clinical regulatory writing activities across a complex portfolio. Ensure that documents meet regulatory, technical, and quality standards.
Authoring Complex Documents:
Write the most complex clinical-regulatory documents such as clinical study reports, regulatory submission documents, and other critical documents that align with project strategies and regulatory requirements.
Strategic Communications Leadership:
Provide leadership in developing the Clinical Submission Communication Strategy (cSCS). Drive the strategic review of complex data and translate it into clear, concise, and impactful messages.
Team Leadership & Collaboration:
Lead internal and external authoring teams. Collaborate with vendor medical writers to ensure timely and high-quality deliverables. Continuously advocate for quality and operational excellence in all communications.
Support Development of Managers:
Support the development of Clinical Regulatory Writing Managers by offering guidance, mentorship, and leadership opportunities.
Continuous Improvement:
Drive continuous improvement initiatives for the Clinical Regulatory Writing function, ensuring alignment with industry best practices and regulatory requirements.
Essential:
Desirable:
At AstraZeneca, we’re committed to continuous improvement and find better ways to impact patients with serious diseases. Our innovative approach to regulatory writing allows us to influence drug development early in the lifecycle and continue to contribute to impactful submissions and approvals.
If you’re passionate about regulatory writing and shaping the future of drug development, we’d love to hear from you. Apply now and become part of a team dedicated to making a difference in the lives of patients.
AstraZeneca values diversity and equality of opportunity, striving to create an inclusive and diverse team that represents all backgrounds. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications from all qualified candidates, regardless of their characteristics. We comply with all relevant non-discrimination laws and regulations.
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