Associate Director, Clinical Regulatory Writing Mississauga, Ontario, Canada
4 days ago
**Location** Mississauga, Ontario, Canada
**Job ID** R-220076
**Date posted** 28/05/2025
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.
As a team, **we author clinical and regulatory documents** that align with project strategies, regulatory requirements, and standard processes. 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**:
- Independently manage clinical regulatory writing activities across a portfolio of work.
- Author clinical-regulatory documents within a program by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and standard methodology are appliedDrive the development of the clinical Submission Communication Strategy (cSCS).
- Lead internal/external authoring teams and provide positive relationships with vendor medical writers to ensure delivery to time and quality.
- Drive the clinical interpretation of sophisticated data and information and condense it into clear, concise and accurate messages that address information 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.
Great People want to Work with us Find out why:
- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel
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