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Takeda Pharmaceuticals DIRECTOR, Lead GRO ANALYTICS in Boston, Massachusetts

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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 Director, Lead GRO Analytics where you will be responsible for analytical and reporting services in support of the Regulatory Affairs business. With a specific focus on regulatory compliance and data quality, data science, and innovative development of systems, solutions, and tools, the RIM Analytics and Reporting team is accountable for maximizing the business value of Takeda’s RIM data and structured/unstructured information. Provide leadership, strategic thinking, and expert execution for engaging with global business stakeholders to understand business capability needs and drive value-driven innovations.

You will also ensure delivery of analytical and reporting services in support of the Regulatory business with a specific focus on regulatory compliance and data quality. Deliver high-quality analytics and reports based on a thorough knowledge of global regulatory processes and business unit requirements, an understanding of the range of available data/information assets, and in-depth analytical expertise to exploit information and data assets.

As part of the Regulatory Information Management and Digital Innovation team, you will report to Head, Regulatory Information Management and Digital Innovation and work with supporting the Regulatory Affairs business.

How you will contribute:

  • Development of the data analytics, reporting and visualization strategy to support GRA and operations functions.

  • Work cross-functionally to align with other data analytics functions, R&D, and Enterprise-wide analytics efforts.

  • Oversee a team responsible for the development and maintenance of reports and dashboards

  • Drive innovation and strategic development of analytical solutions that address business future challenges and needs, ensuring Regulatory business can gain full value from the available information to enable compliance and deliver competitive advantage.

  • By providing critical information in support of business strategy and performance, enterprise-wide regulatory compliance tracking, data quality improvement, externalization, benchmarking, trend analysis, process improvements, and decision support.

  • Have a robust understanding of regulated procedures, systems, and data, and an ability to interpret, integrate and present complex data analysis to a broad range of customers, preferably in the Pharmaceutical industry.

  • Represents Takeda at industry forums regarding data analytics, quality and standards.

  • Responsible for managing and overseeing vendor(s) in relation to information management projects and deliverables

  • Provides independent leadership and direction to external partners on regulatory specifications for submissions and the associated systems to support them, consistent with Takeda and Health Authority expectations.

Minimum Requirements/Qualifications:

  • Bachelor's degree or related experience is required. Scientific or closely related field preferred.

  • At least 8years of experience in Pharmaceutical industry, with 6 years in Regulatory Affairs, research and development, quality assurance/compliance.

  • Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.

  • Knowledge and experience with industry standards is required. Experience with applying knowledge of information management involving undefined frameworks with medium technical complexity and defined scope. Proven ability to liaise with Regulatory Agencies having served as lead in successful Agency Interactions related to data standards, international experience preferred.

  • Understanding regulatory Information management tools is preferred.

  • Experience managing vendors and contracts is strongly preferred.

  • Project Management qualification is strongly 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 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.

Base Salary Range: $160,300 – 229,000, based on candidate 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.

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

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


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.


Boston, MA

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Full time