Associate Director, Clinical Regulatory Writing

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – 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’re 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 an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical delivery or submission team, the Associate Director provides strategic communications leadership to projects, establishes communication standards and best practice, and continuously advocates for quality and efficiency. The Associate Director also authors strategic clinical-regulatory documents and provides critical review to achieve high-quality standards, utilising best practices for document and accelerated submission delivery.

This opportunity is available at our office in Mississauga, Ontario, Canada .

We expect employees to be on-site for a minimum of three days per week, and are therefore unable to offer remote-based working.

What You Will Do

The Associate Director, CReW, is expected to:

·       Independently manage clinical regulatory writing activities across a portfolio of work. 

·       Author clinical-regulatory documents within a programme by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied. 

·       Drive the development of the clinical Submission Communication Strategy. 

·       Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality. 

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

·       Be a strategic thinker and demonstrate strategic review capabilities.

·       Proactively collaborate with other functions at the programme level.

·       Support the development of others in Clinical Regulatory Writing. 

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

Essential for the Role:

·       A Life Sciences degree in an appropriate discipline.

·       5-9 years of experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organisation environment.

·       Experience leading submission authoring and authoring submission-level documents.

·       Understanding of the drug development process from development through lifecycle management.

·       Experience in working within, and contributing to, large, diverse, matrix teams.

·       Excellent verbal and written communication skills in English.

·       In-depth knowledge of the technical and regulatory requirements related to the role. 

·       Flexibility in adapting to changing circumstances and latest information.

Desirable Qualifications:

·       Advanced degree in a scientific discipline, such as a PhD.

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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  View email address on careers.astrazeneca.com

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.