Medical Writer (Clinical Regulatory)

Medical Writer (Clinical Regulatory)

Location: Mississauga, Canada

Competitive salary and benefits

A Diverse Set Of Minds. Bold Game-changers. Significant Impact.

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than just a leading pharmaceutical companies.

Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. 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.

Adopt an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term significant career.

As a team, we author clinical and regulatory documents that align with project strategies, regulatory requirements, and best practices. We support the company’s core therapeutic areas in all phases of clinical development, playing a key part in delivering medicines to patients as swiftly as we can.

Whichever role you’re successful in, you’ll be joining an extraordinary team who has an outstanding record of achieving successful submissions and approvals. Each role will afford you flexibility in ways of working.

Essential Requirements:

• Validated regulatory writing experience from within the pharmaceutical industry and a real passion for helping us to achieve our goal of changing lives

• Bachelor’s degree in life sciences; MSc or PhD preferred

• Solid understanding of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions

• Ability to drive collaboration with vendors

• Extensive knowledge of current regulatory guidelines relating to regulatory communications

• Consistent display of ability in project management, thinking (conceptual, analytical and integrative), influencing and team working.

• Flexibility in adapting to changing circumstances or new information.

To best support our employees in balancing personal and work commitments, we’ve embraced a hybrid model of working that gives employees flexibility in how they manage their time. 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 commitment 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 bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.