Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

We are now recruiting a Director, Clinical Regulatory Writing (CReW). The Clinical Regulatory Writing team provides experienced 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 essential communication excellence to achieve successful submissions and approvals.

The Clinical Regulatory Writing Director provides authoritative 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 experienced leadership to deliver submission communication strategies and drive the authoring of large clinical submission packages and other sophisticated clinical documents that are aligned with project development plans, regulatory requirements, and communications standard methodologies.

Be a proactive, independent, and innovative leader of large, sophisticated 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 standard methodology 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.

Steadfast in the pursuit of excellence, driven to improve standards across the business. Recognize opportunities and orchestrate 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.

Minimum Qualifications:

Life Sciences degree in an appropriate subject area.

We require a minimum of 7 years\xe2\x80\x99 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!

Great People want to Work with us! Find out why:

So, what\xe2\x80\x99s next!

Are you already imagining yourself joining our team? Good, because we can\xe2\x80\x99t wait to hear from you.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 06-Jul-2023

Closing Date 28-Dec-2023

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 authorization and employment eligibility verification requirements.

AstraZeneca