At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.
Our purpose is bold and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.
Are you curious about how pharmaceutical products are approved in Canada? Do you want to help improve patient access to life changing medications? Are you a passionate organizer with strong attention to detail? In this position, you will support the delivery of Health Canada clinical trial approvals, maintain product compliance and contribute to maximizing a product’s potential and lifecycle in the Canadian marketplace.
In this position you will learn about and be responsible for:
- Preparation, submission and support for timely filings and approvals of Clinical Trial Applications, Amendments and Notifications
- Support External Sponsored Research with filings and Health Canada review process
- Serve as local Clinical Study Team representative
- Assist with the development of responses to Medical Information, Clinical and Commercial requests (as required)
- Ensure regulatory submissions and documents are compliant with both Health Canada and AstraZeneca corporate requirements and standards (e.g., Electronic submission processes)
- Develop and foster positive relationships with stakeholders, including Health Canada
- Conduct therapeutic area-specific research (for Senior Manager/Project Manager, as required)
- Actively support the Regulatory Affairs department to maximize efficiency, performance and productivity.
- You have completed a University degree, in a related (health science) discipline
- You are available for an 8-month position from May 2019 to December 2019
- You have awareness ofthe Canadian regulatory environment and Health Canada regulations, policies and guidelines considered an asset
- You enjoy project management and have strong time management skills
- You take pride in your written and verbal communication skills
- Your interpersonal skills are a strength and you thrive with teamwork, taking a customer service approach to your work while working with others
- You are detail oriented
- You are savvy with Microsoft Office applications