Manager, Medical Ethics
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and ignite your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
AstraZeneca in Canada
Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, entrepreneurial thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
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 andBlueSky Hubin 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.
Build and maintain positive working relationship across TAs in support of internal processes and practices.
Act as an advisor on the application of internal/external code of practices (internal policies, IMC Code, PAAB, requirements related to corporate compliance)
Act as Nominated Signatory business units and for non-brand and above brand material and activities as per global and local policies and SOPs.
Maintain a broad knowledge of Onc/RIA/CVRM brand data, messaging and undertakings and integrate the detailed input of Medical Advisors on scientific content and Regulatory for alignment with label into final recommendations and guidance and to inform sign-off as appropriate.
Promote best practice by sharing successes and by helping to identify/resolve issues with Brand and Scientific Affairs teams
Collaborate cross-functionally with Subject Matter Experts (SMEs) in Medical Scientific Affairs and Brand supporting the team with advice on internal review/approval processes (including material review, pre-market authorization Advisory Board Governance)
Support the Fair Market Value requests via the Nominated Signatory platform and Canadian Fair Market Value assessments through assisting verification of qualification, licence validity, and application of the FMV guidance when requested
Support Scientific Affairs First Line Monitoring, as well as internal audits, risk assessments and other Medical Ethics needs
Support Patient Assistance Program through compliance review and documentation.
Act as a role model and ensure ethical/professional behaviour
Support training and communication in relevant SOPs and local market ethical standards and practice
Bachelor’s Degree is required. Minimum 3 years of experience in quality, compliance or regulatory in a regulated environment such as pharmaceutical, clinical, or medical devices
In-depth knowledge of the IMC code, Health Canada regulations and associated guidance documents
Experience in process mapping, project management skills, ensuring projects are executed on time
Excellent communications skills (written, spoken and presentation)
High level of attention to detail is required
Ability to work highly collaboratively with a solution-oriented mindset and to prioritize a matrixed environment
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 8 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
Best Workplace Culture Award at the 2018 Canadian HR Awards:https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
Browse AstraZeneca's YouTube channel to find out more about us:https://www.youtube.com/user/astrazeneca
Are you interested in working at AZ, apply today!
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.
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 AZCHumanResources@astrazeneca.com.
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 authorisation and employment eligibility verification requirements.