Manager Data Governance, Regulatory Data Quality

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Join Takeda as a Manager OF Data Governance - Regulatory Data Quality, where you will provide quality oversight (data error detection and correction) on business processes where data is collected, stored, transformed, or used. Strong data analysis skills and an understanding of international data standards will ensure clean data that can be enacted upon by analytic systems and transactional applications, thereby maintaining our high-quality standards for Master and transactional Data.

You will also assist the team in integrating data assets from a variety of systems and sources (external and internal) into Company’s RIM systems, ensuring and monitoring the final quality of our internal data stores and flows. As part of the Regulatory Affairs Operations team, you will report to the Director of Regulatory Affairs Operations.

How you will contribute:

• Responsible for monitoring data quality and implementing data controls and remediating data quality issues.
• Leads efforts in defining appropriate metrics to measure the quality of the data relative to usability and compliance with internal and regulatory policies.
• Create, review, and maintain data quality standards and controls within Data Catalog.
• Assist in developing and implementing data classifications and access policies.
• Ensure that standard project methodology is followed, and that policies, procedures, and metrics are in place for maintaining/improving data quality and the creation, capture, and maintenance of metadata.
• Ensure that sensitive data is always protected by using approved controls.
• Communicate escalations, concerns, and issues with data to the individuals that can influence change.
• Participate in cross-business unit resolution of data definition, production, and usage issues.
• Support root causes analysis on data issues and recommends data quality controls to resolve gaps/issues.
• Define process, frequency, and responsibility for identification of metadata discrepancies and resolution.
• Oversee the maintenance of the Data Quality issues Tracker.
• Communicate the importance of data quality problems and their potential impacts and take the lead in resolving them via data integration and/or business process improvement.
• Identify and document regulatory and legal risks for data issues and escalate as needed.
• Analyze data for compliance to design specification (source-to-target) and expected/anticipated behaviors, identifying quality issues and recommending solutions.
• Support and share knowledge with other stewards, trustees, etc.
• Performs data quality analysis, data profiling, evaluation, and issues root-cause analysis of the data in diverse platforms including MS SQL, Excel, Oracle, Informatica, and third-party applications.
• Investigate, troubleshoot, and document data issues from internal and external customers.
• Establish, monitor, and report on Service Level Agreements of external outsourcing vendor as it relates to data quality assurance and production data maintenance performance.

Minimum Requirements/Qualifications:

• BS degree required, advanced degree preferred.
• 5 years of experience in the Healthcare/Pharmaceutical industry.
• 5 years of relevant work experience in data management/data governance role.
• Strong experience and advanced understanding of the collection and management of regulatory metadata (as it relates to the governance of data and data quality).
• Should have experience with, and understanding of, implementing, and measuring Data Quality and Controls.
• Must be able to identify, analyze and address problems to resolve issues whenever possible in a way that minimizes negative impact and risk to the organization.
• Understanding of Pharmaceutical Data Standards; US and International (IDMP, SPOR, EDQM, XEVMPD, PQ CMC…).
• Ability to work with Technical and Non-Technical business owners.
• Familiarity with Veeva RIM Data Model.
• Experience with Labeling, CMC, and Regulatory processes.
• Familiarity with industry-standard data management frameworks such as DAMA DMBOK, EDM DCAM, and/or CDMC.
• Experience with Collibra or similar data management solutions.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and a company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $ 102,000 - 146,000, based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time