Job Description

This opportunity is available at our Waltham, MA, Gaithersburg, MD and Munich, DE locations.

Would you like to apply your expertise to impact the compliance principles and standards in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you\xe2\x80\x99re our kind of person.

The Oncology Data Science (ODS) organization has recently been established to centralize data, engineering, analytics, and AI expertise to drive the early and late Oncology drug development portfolio with data science-driven insights. As such, there is a heightened emphasis for this central ODS organization to enable collaborative analytics across Oncology teams and support the development of analytics focused strategic alliances with academic and technology industry leaders to enhance our portfolio. The Compliance Program Manager will be an integral part of a developing team that works across this dynamic landscape translating ODS objectives into strategic initiatives, creating business cases, and providing compliant frameworks supporting highly talented teams in achieving their goals. Specifically, the Compliance Program Manager will be responsible for creating a culture of ethics and integrity while developing a centralized compliance program for Oncology Data Science.

Major Duties and Qualifications:

Develop and maintain a balanced risk based compliance program for Oncology Data Science partnering with the Data Office, Data Privacy Office, Human Biosamples, IT, and Quality to ensure our data use, analytics methodologies, and platforms adhere to company policies, relevant laws, regulations, and ethical standards

Develop a compliance evidence management strategy; provide evidence reports to senior leaders and/or regulators; and lead ODS audits, inspections, and remediation efforts

Act as the central point of contact in Oncology Data Science in answering compliance questions navigating the complex landscape of internal policies and evolving external regulations in various countries

Guide risk based data strategy and technology discussions infusing quality and privacy by design in our systems and processes

Contribute to the development and enablement of external strategic alliances with academic and technology industry leaders; establish and execute a playbook ensuring data transfer, data privacy, security, and other regulatory requirements are met

Maintain relationships with key stakeholders and close awareness of corporate initiatives and industry standards/regulations

Actively contribute to ODS\xe2\x80\x99s fun and innovative culture, bring your authentic self, take time for community, celebrate the diversity of thought and identity, take risks, and accept failures

Contribute to the evangelism of ODS\xe2\x80\x99s prowess and accomplishments through targeted communications, celebration of achievements, conferences, and/or external communication

Minimum Qualifications:

Bachelor\xe2\x80\x99s degree from an accredited university in a relevant scientific and/or technical field

Demonstrated 5+ years of experience managing data privacy, clinical development, diagnostic development, translational science, and/or IT systems compliance evidence in the biotech/pharmaceutical industry

Experience developing a program; establishing ways of working, risk management strategy, policies and procedures, evidence management strategy, training strategy, networking and communications strategy

Working knowledge of relevant laws and regulations including intellectual property, data privacy, human biosamples, GCP and GLP, and/or responsible AI standards

Demonstrated working knowledge of software development lifecycle (SDLC) and system qualification/validation criteria

Proven ability to tackle the unknown and translate compliance questions into an actionable plan

Ability to guide risk based data strategy and technology discussions infusing quality and privacy by design

Highly collaborative with experience influencing and communicating cross-functionally with stakeholders

Energized by leading talented and diverse teams toward a common goal, often translating through communication gaps

Understanding of R&D, data science and AI, informatics, records management, and system development in the biotech/pharma industry

Desirable Qualifications:

Established network in Oncology R&D, Data Office/DSAI, Data Privacy Office, Human Biosamples, IT, and/or Quality

Clinical, diagnostic, or translational science operations experience desirable

Experience with data and AI regulations in China is highly desirable

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we\xe2\x80\x99re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what\xe2\x80\x99s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it\xe2\x80\x99s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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Date Posted 25-Apr-2023

Closing Date 24-May-2023

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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca