Do you have experience working with Regulatory Data Governance and Data Quality and would like to work in a global team environment?
Are you interested in a new challenge in the ever-changing environment called RIM (Regulatory Information Management) and in particular with Data Governance, Data Standards, Data Quality Management and Data Policy? Then this role is something for you!
At AstraZeneca we're dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. AstraZeneca has an inclusive culture that champions diversity and collaboration where we are always committed to lifelong learning, growth and development.
We are now looking for an Associate Director, Regulatory Data Governance and Data Quality to join us in Global Regulatory Operations (GRO) within Regulatory Affairs. This is a growing area within a globally connected business, and a place to share learnings and best practices with our leading Regulatory specialists. Working across our locations, therapy areas and external community means we're comfortable stepping up, willing to take ownership of our work, in an effort to find solutions for the business and our personal career development.
What you'll do
As an Associate Director, Regulatory Data Governance and Data Quality you will provide governance and stewardship of Regulatory Data, from within GRO to a global network, across the Chief Medical Office (CMO), Research and Development (R&D), Operations and externally. The role combines a comprehensive understanding of health authority requirements and standards applicable to regulatory data, business unit requirements and dependencies around these data, with the in-depth systems expertise that is critical to enable effective governance of data. You will coordinate the approach to data governance across our regulatory systems and in relation to allied systems in other functional areas, manage relationships with business customers and stakeholders, as well as IT support organisations, in order to ensure early insight into changing requirements and a timely response to them.
The role also encompasses work across AZ for regulating use of the RIM platform through the implementation and enforcement of standards and processes, including the successful implementation of, and ongoing compliance with, HA-driven data requirements and standards such as XEVMPD (Eudravigilance Medicinal Product Dictionary) and IDMP (Identification of Medicinal Product).
We are striving for technology adoption and automation to drive efficiencies and new innovations. In so doing, you will support, coach and provide guidance to other personnel in relation to regulatory data management. It's by delivering rapid and global approvals that we play our part in turning meaningful innovation in drug development strategies into reality.
The role also includes:
Implementing the Global Regulatory Data Governance strategy, goals and roadmap, within the Regulatory area, aligned to the AZ wide strategy.
Implementing the Global Data Governance Framework which supports the overall strategy.
Reporting on performance of data governance processes, standards, quality and compliance within Regulatory area.
Providing subject matter expertise for internal stakeholders to influence the overall direction for projects with a data component to achieve compliance with data policies and mitigate high level risks.
Harmonizing regulatory data across processes and systems, in alignment with enterprise data management initiatives
Implementing current and emerging data standards such as xEVMPD, IDMP, CTDir and FMD.
Working collaboratively with technical experts, process experts and data owners to ensure delivery of the Regulatory data strategy..
Operate and provide expert knowledge in some or all of the following areas: Data Governance, Data Standards, Data Quality Management, Data Policy and Compliance/Risk Management.
Essential for the role
Bachelor's/Master's degree in a scientific, business or information sciences discipline, and/or relevant experience in the bio-pharmaceutical industry
Proven experience and technical competence in developing and deploying solutions in support of regulatory information management (e.g. EVMPD)
In depth knowledge of procedures and compliance standards governing the management of regulatory and/or pharmacovigilance data (e.g. EVMPD, ICH M5, HL7).
A broad understanding of the Regulatory value chain and drug development activities and the challenges associated with managing data in support of critical business and compliance activities
Knowledge of procedures, processes and standards governing the submission and exchange of electronic information with Health Authorities and experience of implementing these in the business
Knowledge of current developments in the pharmaceutical industry and global regulatory environment and their potential impact on regulatory compliance