Director, Clinical Regulatory Writing
Are you passionate about Clinical Regulatory Writing? Would you like to have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us!
We are now recruiting a Director, Clinical Regulatory Writing (CReW). The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support across all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.
The Clinical Regulatory Writing Director provides expert communications leadership for the most sophisticated and business-critical clinical activities by driving strategic content development in alignment with product strategy and communications excellence.
The Clinical Regulatory Writing Director is expected to:
Provide expert leadership to deliver submission communication strategies and drive the authoring of large clinical submission packages and other complex clinical documents that are aligned with project development plans, regulatory requirements, and communications best practices.
Be a proactive, independent, and innovative leader of large, complex teams delivering business needs of the highest priority.
Delegate and empower other internal and external writers, and ensure relevant regulatory, technical, and quality standards are achieved and the appropriate processes and best practice are applied.
Build robust clinical arguments through strong analytical and communications skills and critically evaluate clinical trial designs.
Effectively influence collaborators and colleagues at the highest levels of a program to establish the best communications practices.
Relentless in the pursuit of excellence, driven to improve standards across the business. Recognize opportunities and spearhead improvement initiatives at the TA or company-wide level.
Lead and prioritize multiple projects in parallel, often working under accelerated timelines to deliver.
Work independently and support the growth and development of the group by actively mentoring Clinical Regulatory Writing Associate Directors and Managers and serving as a role model for the function.
Life Sciences degree in an appropriate subject area.
We require a minimum of 7 years’ experience
Significant medical writing experience in the pharmaceutical industry.
Ability to advise and lead communication projects
Understands drug development and communication process from development, launch through life cycle management.
In depth knowledge of the technical and regulatory requirements related to the role
Extensive experience in clinical programs, study design and data analysis
If this sounds like the type of organization where you would like to grow your career and make a real difference to patients then we would like to hear from you; apply today!
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Where can I find out more?
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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 authorisation and employment eligibility verification requirements.