Medical Ethics Manager
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, we've been recognized as one of Greater Toronto Area's Top Employers for 7 straight years. Our collaborative work environment champions knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we're working towards making a positive impact where society needs it - health. We know the health of people, the planet and our business are interconnected, each impacting the others.
Act as Nominated Signatory across TAs 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.
Drive intelligent compliance through adherence to the IMC Code of Practice utilizing Nominated Signatory experience.
Promote best practice by sharing successes and by helping to identify/resolve issues with Brand and Scientific Affairs teams.
Support cross functional teams with advice on signatory process management
Pre Market authorization Advisory Board Governance.
Support and approve International FMV requests via the Nominated Signatory platform
Support Canadian Fair Market Value assessments through assisting verification of qualification, licence validity, and application of the FMV guidance when requested
Coordination of Scientific Affairs First line Monitoring
Participation in, monitoring and tracking of, activities to ensure audit readiness of all processes and associated activities listed above
Support Patient Assistance Program through compliance review and documentation, including PIA assessments
Act as a role model and ensure ethical/professional behaviour
Support training in relevant SOPs and local market ethical standards and practice.
Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures
Masters in a relevant field. Relevant fields are inclusive of Pharmacy/Life Sciences/Medical areas
At least 5 years experience in the pharmaceutical industry and at least 2 years working in a compliance related function
In-depth knowledge of the IMC code, the Health Canada Food and Drug Act and associated guidance documents
Ability to work highly collaboratively with a solution oriented mindset.
Ability to prioritize work in a matrixed environment.
Strong interpersonal and influencing abilities.
Excellent communications skills (written, spoken and presentation)
Doctoral degree (MD, Pharm. D, or Ph.D)
Fluency in French an advantage
Experience in a at least one of the AstraZeneca therapeutic area an advantage
Here you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 7 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!
AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.AstraZenecais 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.