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Associate Director Data Governance
Join a Legacy of Innovation 110 Years and Counting!
Daiichi 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 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.
Daiichi 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 15,000 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.
This person will work with a cross-functional community, to enable good data stewardship based on rules and standards set supporting business ownership and data stewardship of critical corporate data assets. They will communicate the concepts and criticality of business data stewardship and ownership to all levels of the organization including those working with the data domains on a day-to-day basis as well as Senior IT & corporate business executives.
This role has the flexibility to function on a remote basis for those outside the region OR corporate Basking Ridge NJ site based.
- In conjunction with the Data Governance Lead, Develop & implement Data Stewardship community and set of practices to manage data as an asset. Communicate and help the community manage good data governance policies and their importance / relevance to key constituents, information stewards, system owners, stakeholders and data consumers acting as both a "traffic" cop to stop bad data and an active advocate for good data practices.
- Chairs a Data Stewardship community which reports to an existing R&D Data Governance governing body/council. This role will help build the community, establish good processes and structures and will consist of representatives from individual data domains representing a cross section of the organization. Reports individually to the R&D Data Governance lead and organizationally to the R&D Data Governance body.
- Lead and mentor the Data Stewardship community matrixed team members globally. Ensure community team members are trained on DG methodologies, frameworks, technologies and processes.
- Collaborates with domain experts in privacy, security, and compliance to ensure that the data platforms uphold privacy, security, and compliance requirements within the context of the individual data domains.
Collaborates with IT and Data Architects in contributing to requirements for enabling technologies to support data stewardship and governance processes, data standards and mastering, data quality and data management.
- Bachelor's Degree 7+ years of experience in life sciences, pharma or informatics industry working with Clinical Trials, Genomics / Bio Markers, Discovery , Real World data etc. required
- Master's Degree 5+ years of experience in life sciences, pharma or informatics industry working with Clinical Trials, Genomics / Bio Markers, Discovery , Real World data etc. preferred
- 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
- 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: Electronic Records, Electronic Signatures
o 21 CFR § 312.32: 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 cross-functional users
o 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 preferred - 4 or More Years Excellent communications skills (written, verbal) to express complex points to a variety of stakeholders and drive change through persuasion not organizational power. required
- 1 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) preferred
- 1 or More Years Previous experience with some aspect of data-focused capabilities such as Data Quality, Master Data Management, Reference Data Management, Data Retention & Archival , Data Access Control & Data Security software. preferred
- 1 or More Years Some hands on experience with contemporary data governance platforms/technologies like Collibra, Informatica DG, Alation, Erwin DG, DATUM, Infogix etc. preferred
- 1 or More Years Strong hands-on data manipulation skills through excellent Excel, SQL or data preparation tools like Alteryx. preferred
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.
Recommended Skills
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