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 Manager, 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 the Company\xe2\x80\x99s core therapeutic areas in 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 Manager is encouraged to:

With limited mentorship, lead document authoring, author and ensure the timely delivery of high-quality clinical regulatory documents such as CSPs, CSRs, IBs, Module 2.7 submission documents, briefing documents, pediatric plans, regulatory response, and specific documents supporting established brands.

Ensure that relevant regulatory, technical and quality standards are achieved, and that relevant processes and standard methodology are applied.

Can balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.

Drive the clinical interpretation of data and information and condense it into clear, concise, and accurate messages that address customer information requirements.

Provide critical review of documents for correctness, clarity, completeness, and compliance.

Proactively collaborative with other functions and external service providers/contractors during document development.

As part of a clinical delivery team, provide communications support to projects, establish communication standards, and best practice, and continuously advocate for quality and efficiency.

Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required.

Work independently but with the mentorship and support of more senior members of the group.

Minimum Qualifications:

Life Sciences degree in an appropriate subject area.

We require a minimum of 3 years\xe2\x80\x99 experience

Experience in medical writing.

Strong communication and leadership skills.

Knowledge of the technical and regulatory requirements related to the role.

Essential Qualifications:

Advanced degree in a scientific field (PhD)

Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.

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!

Why AstraZeneca?

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\xe2\x80\x99re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

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 30-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