- Lead and work with functional business data stewards on data quality initiatives
- Collaborate with the data stewardship community members of functional units globally and ensure community team members are trained on the data governance methodologies, frameworks, and processes. This person will be expected to collaborate with many stakeholders in the data area including functional representatives, corporate representative, IT, privacy, legal, compliance, IT security, etc.
- Collaborate with an extensive cross functional team including business stakeholders from multiple functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital transformation unit, IT, data architects and digital technology teams to support data stewardship and governance processes, data cataloging data standards, data quality, and data management.
- Develop and implement strategies for cleansing and standardizing data, with a focus on e.g., clinical, product, and vendor data and Identify and rectify data anomalies, inconsistencies, and errors through effective data profiling and analysis
- Support the creation of automated, scalable approaches for data quality issue identification, support mitigation, the development and implementation of data quality standards and data protection standards, processes, and procedures within the organization.
- Partner with business data stewards across functional areas and technology stakeholders to resolve data conflicts, process issue, and oversee the implementation and documentation of the appropriate governance structure to prescribe data handling, protection, and user provisioning controls
- Identify, assess, monitor, document, and communicate potential quality issues in the way data is collected, stored, processed, or used as part of data capability enablement. Bachelor's Degree Computer Science, Marketing, Communications or a related field from an accredited college or university required
- 4 or More Years Previous experience with a data governance program, data stewardship program or similar intent data management program focused on setting standards, policies, and guidelines for active governance of organizational data ideally around the R&D Pharmaceutical or Healthcare industry required required
- 4 or More Years Experience with data capabilities such as modern data catalogs, metadata managers and lineage capabilities. 4 or More Years Experience with data quality tools e.g., Precisely Trillium, Informatica Data Quality, required
- 4 or More Years Experience in life sciences, pharma or informatics industry working with Pharmaceutical R&D data across the organization including corporate entities such as financial, HR, etc., and some functional related R&D or Commercial type data. 4 or More Years Understanding of principles, practices, theories, and/or methodologies associated with the professional disciplines, as outlined in Data Management Body of Knowledge (DMBOK2) required
- 4 or More Years Familiarity with and understanding of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the following: o 21 CRF § 11: 32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs – Improving Human Subject Protection (January 2009) o FDA Guidance for Industry and Investigators Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan Ministry of Health, Labor and Welfare artifacts o Security and protection of organizational data assets o Access Control leveraging administrative controls of data access rights for crossfunctional users of Data Enrichment services, including data standardization, natural language processing o Data Quality operations that standardize data definitions, implements quality rules, and aligns with quality management system required
- 4 or More Years Some handson experience with contemporary data governance platforms/technologies like Collibra, Informatica DG, Alation, Erwin DG, DATUM, Precisely etc required
- 4 or More Years Strong handson data manipulation skills through excellent Excel, SQL, python etc. and any data preparation tools like Alteryx and other data quality tools required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Manager, Medical Compliance - New Jersey, United States - Daiichi Sankyo, Inc.
Description
Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.
With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
The Manager of Data Governance Stewardship will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, data quality, metadata management, lineage capabilities and the data governance processes surrounding these capabilities, and the data governance program in general.
This role will help support the overall data governance effort by providing data stewardship guidance across the business functions including advocating for good data governance, stewardship, data identification, and data quality to enable business outcomes.
Expand and lead our Data Stewardship Working Group (DSWG) across functional areas.This includes:
oFacilitating and coordinating data issues across business functional areas in conjunction with the business data stewards oCreating and executing the processes around the data and resolving any data issues, registering, updating, managing lineage, and adding context metadata in a structured fashion
In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data stewardship community and set of practices to manage data as corporate assets.
Communicate and help the community manage good data governance and their importance / relevance to key constituents, information stewards, system owners, stakeholders, and data users.