12 months contract position

About AstraZeneca

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.

Our Position

Reporting to the Director, Medical Evidence, the Medical Evidence lead will work across the business to:

• Plan and deliver observational research and Real World Evidence (RWE) studies across various therapeutic areas in Canada

• Lead the development and execution of comprehensive evidence plans for both pre-launch and launched products to address full breadth of internal and external stakeholder needs

• Identify and collaborate with key external experts to address identified evidence gaps, including academic-clinical investigators, health outcomes researchers and contract research organizations (CROs)

• Work collaboratively with Medical Advisors and Market Access colleagues to develop AstraZeneca-sponsored study protocols for local observational studies, as well as review and advise on externally sponsored research proposals

• Identify and evaluate new health database and disease registry opportunities in Canada that could be used for real world studies in therapy areas of interest

• Liaise with global counterparts for all evidence generating activities and lead the review and approval process for local studies at AstraZeneca Canada

• Drive local and global study teams in order to deliver project-specific milestones and resulting scientific publications (e.g., conference presentations, peer-reviewed journal manuscripts) according to deadlines (e.g., HTA submission target)

• Develop and manage communication and knowledge translation plan for all evidence generating activities and ensure presentation of study results to appropriate internal and external stakeholders (e.g., HTA meetings)

• Lead site start-up activities such as ethics submission, informed consent review, development and finalization of research study agreements and follow-up and maintenance of all study related activities, if required, in accordance with AstraZeneca and international regulatory requirements.

• Develop and maintain study budget, timelines and resources and ensure appropriate updates are made to internal tracking systems

• Prepare, execute, track, collect, review and assess study documents and ensure their completeness according to external guidelines and AstraZeneca SOPs

• Complete study feasibilities for Global Non Interventional Studies in collaboration with the local team and global counterparts

• Provide in-house epidemiology, statistics, and observational research methodology expertise to cross-functional partners, including Medical, Market Access and Regulatory teams

Qualifications:

• Master’s degree or PhD epidemiology, health research methodology and/or biostatistics required).

• Understanding of statistical principles and methodologies applicable to observational and other types of real-world studies (eg pragmatic trial design)

• Experience in data analytics and/or ability to work with different health databases an asset

• Excellent understanding of observational study methodology (design and interpretation) and externally sponsored research including clinical and pre-clinical research

• Demonstrated track record in observational research, demonstrating both strategic and tactical elements; experience in multiple therapy areas an asset, particularly respiratory, inflammation, with additional experience in infectious disease and vaccines

• Demonstrated leadership ability in a team environment

• Experience in project management

• Excellent interpersonal, verbal and written communication skills

• Self-motivated and able to display autonomy and initiative – for instance; able to take action, move actions forward and make decisions without the need for continual supervision or consultation.

• Ability to interact with key external customers, including governments, payers, academic researchers and physicians

• Effective time management skills

• Good knowledge of MS Office (Word, Excel, PowerPoint)

• Knowledge of French is an asset

• Experience leading or participating in observational research and real world evidence (RWE) studies

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!

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.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.