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Manager, MDM Substance Data Steward

Location Warsaw, Mazovia, Poland Krakow (City), Lesser Poland, Poland Job ID R-213824 Date posted 21/11/2024

Be empowered to be innovative and creative where difference is valued

Would you like to be a part of a Data Science & Artificial Intelligence (DS&AI) group that has direct strategic impact on drug development, playing a key role in getting medicines to patients?  

At AstraZeneca, we are constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a real passion for discovery and a pipeline to show for it. Here, you’ll have the opportunity to make a difference in people’s lives every single day. 

AstraZeneca is investing in data management and analysis capabilities, through its long-term Growth Through Innovation Strategy.  The DS&AI team collaborates across R&D to drive innovation through data science and AI. Together we seek to:

  • Improve our understanding of disease and uncover new targets 
  • Transform R&D processes 
  • Speed the design and delivery of new medicines for patients  

This is the place that’s investing in the latest technology, data and innovative ways of working. Here you’ll be backed with everything you need to be at the forefront of digitising our organisation. Whether that’s working on the leading-edge, defining the future of Pharma or upskilling yourself in our Digital and Data Academy.

The R&D Data Office, within DS&AI, is a key organization to deliver upon AstraZeneca’s strategy. Data Office operates a central capability, with R&D wide accountability, to ensure that we harness the power of data to drive innovative science. Data Office will govern data, drive data quality and ensure our data is readied for analytics, creating paved-paths for scientists to perform data-driven research, without compromising our legal restrictions or ethical principles.

Within Data Office, you will work in the Reference and Master Data team. The team owns the development, deployment and subsequent oversight of the end-to-end process of stewarding, curating and provisioning quality Reference and Master data. Our mission is to support R&D users with the highest quality of Reference and Master Data within the rigor of the appropriate compliance framework.

MDM Substance Domain Data Steward Manager holds a pivotal role in overseeing Master Data Stewardship services and actively engaging in diverse MDM projects. This position demands a strong scientific background, especially in the field of molecular biology and drug discovery, as it involves registering new Active Pharmaceutical Ingredients and collaborating with Scientist Leads to ensure substances are registered in the requisite format. Moreover, the role demands proficiency in data generation and the capacity to categorize and describe chemical and biological substances according to approved formats. Responsibilities extend to providing leadership, offering strategic guidance, ensuring data quality, managing data risks, and upholding data protection requirements. Additionally, the role encompasses refining processes, guiding stakeholders on effective data practices, and collaborating with them to establish and enforce data standards.

Essential Requirements:

  • Scientific Background and ISO IDMP Standards: Candidates must possess a strong biological background with a deep understanding of ISO IDMP standards. Demonstrated experience in the pharmaceutical/healthcare industry or drug discovery sector, with a focus on biological sciences, is essential.
  • Technology Proficiency: Familiarity with data management tools, and tools used in scientific research and MDM processes is important. Understanding how product data flows and connects between different systems is also valuable.
  • Cross-functional Collaboration: Experience in collaborating with cross-functional teams, including R&D, manufacturing, quality, and regulatory affairs, to ensure alignment of formulation data within the broader context of drug product development.
  • Data Analysis and Problem-solving Skills: Strong ability to analyze complex chemical and biological data, identify gaps, and suggest data-driven solutions to improve the MDM system for better substance registration.
  • Communication and Leadership: Candidates should have strong leadership skills, including the ability to solve complex problems involving multiple decision-makers and develop various options or recommendations. They must have good networking skills and be able to interact effectively across different departments and disciplines within the company. Excellent verbal and written communication skills are necessary, as well as the ability to build strong relationships with Stakeholders.
  • Continuous Improvement Mindset: Proactive approach to continuous improvement, including the ability to identify opportunities for optimizing MDM processes and enhancing data quality within the Substance Domain of Science MDM

Desirable Requirements:

  • Master Data Management (MDM) Knowledge: Understanding of Master Data Management principles and practices, including data governance, data quality management, data integration, and data lifecycle management.
  • Experience in Technology Implementation: Proven experience in implementing technology solutions.
  • Experience in Project Management: Demonstrated experience in managing projects effectively.
  • Experience in Process Development: Skilled in developing and optimizing processes.
  • Regulatory Compliance: Solid understanding of regulatory requirements related to drug new drug registration, including knowledge of relevant guidelines such as ICH, FDA, and EMA regulations.
  • Experience with Clinical Data Curation: Familiarity with curating clinical data and adhering to industry standards.
  • Operational Understanding of Data Models and Standards: Familiarity with common data models, standards, vocabularies, and ontologies, and their implementation within a centralized repository.
  • Good Facilitator, Communicator, Negotiator, and Enforcer: Strong skills in facilitating discussions, communicating clearly, negotiating agreements, and enforcing policies.
  • Experience in Data Warehousing and Modeling: Proficiency in data warehousing, data modeling, data profiling, and relational databases.
  • Understanding Compliance Regulations: Knowledge of external and internal compliance regulations to ensure data is organized, maintained, and safeguarded against theft or misuse.

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.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.