Regulatory Data Governance Lead

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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 in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Regulatory Data Governance Lead where you will ensure Regulatory information and data standards are aligned with Takeda's strategic business requirements (e.g. MDM, Regulatory strategy, Industry standards, HA expectations). Working closely with our Regulatory Operations team, you will have the opportunity to assist the team in integrating data assets from a variety of systems and sources into Takeda’s RIM systems, ensuring and monitoring the final quality of our internal data stores and flows.

You will also be a strong collaborator and partner, focused on process improvement, and navigate a highly federated organization. Your experience with metadata and data catalog management within a large organization will allow you to be an advocate for best practices in metadata creation, management, and distribution across all Regulatory functions and partners. As part of the Regulatory Operations team, you will report to the Director of Regulatory Operations.

How you will contribute:

• Oversee the establishment of Regulatory data governance policies.
• Identify and assign data standard roles (Data Quality, stewards, owner) for the regulatory data domain.
• Owner of the Regulatory Data Catalog: Document Data classification and quality rules.
• Oversee Regulatory Documents data classification rules, compliance/retention rules, and business rules and access policies.
• Lead efforts in defining appropriate metrics to measure the quality of the metadata relative to usability and compliance with internal and regulatory policies.
• Define process, frequency, and responsibility for identification of metadata discrepancies and resolution.
• Establish the data management practice and process: Own, lead, and manage all aspects of RIM/eDMS metadata management practice including capture and maintenance, lineage, sensitive data tagging and management, metadata standards, and data discoverability.
• Ensure that the metadata framework captures all relevant metadata needed for regulatory needs as well as data management compliance.
• Represent Regulatory team in cross-functional Data Governance initiatives and participate in the cross-business unit resolution of data definition, production, and usage issues.
• Drive adoption of metadata management practice through training and effective change management across stakeholder groups.
• Participate in forums (with other domain trustees/stewards, etc.) to communicate change management and address specific issues related to their domain and business unit.
• Support Change Management and Regulatory Intelligence assessment processes to evaluate the impact on Regulatory Data.
• Support the definition of the RIM data Roadmap, RIM Architecture diagrams, and Interface Specifications.

Minimum Requirements/Qualifications:

• BS degree required, advanced degree preferred.
• 8 years of experience in the Healthcare/Pharmaceutical industry.
• At least 5 years of relevant work experience in a data management/data governance role.
• Must-Have strong experience and an advanced understanding of the collection and management of regulatory data and regulatory documents.
• A desire to be a hands-on contributor, proactive, and able to drive the direction of work that needs to be completed.
• Knowledge of Metadata Management and Master Data Governance best practices.
• 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.
• Familiar with Data Catalog and Data Catalog / Data Management Tools (Collibra or other).
• Understanding of Pharmaceutical Data Standards; US and International (ISO, ICH, IDMP, SPOR, EDQM, XEVMPD, PQ CMC).
• Familiarity with industry-standard data management frameworks such as DAMA DMBOK, EDM DCAM, and/or CDMC.
• Familiarity with Veeva RIM Data Model.
• Experience with Labeling, CMC, and Regulatory processes.
• Experience implementing technology solutions either as a project, technical, or functional lead.
• Experience with public and hybrid cloud environments.
• Experience working in a GxP environment is preferred.

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: $ 143,500 - $205,000, 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