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Job Description

Takeda is advancing an exciting product pipeline and wants to ensure that we have the infrastructure and talent in place to support it. Our overall goal is to get our therapeutics to patients quickly by having the right operational model and integrated clinical data pipeline to support delivery.

As a Senior Business Analyst (Veeva), you will identify, align, and document business requirements and process improvements and you will contribute to Takeda’s mission by helping to define business priorities for changes and system implementation of Veeva Clinical suite.

In a typical day, you will:

• Lead business requirements documentation and alignment for complex system implementations.

• Translate technology solutions to business objectives, considering the implications of change for the organization and all stakeholders.

• Solve problems, advise about operational needs, and give expertise on business processes opportunities.

ACCOUNTABILITIES :

• Veeva Business Analyst is responsible for planning, design, configuration, deployment, and support of Veeva systems - eTMF/CTMS and CDMS

• Primary subject matter expert for support for teams using the Veeva Clinical (eTMF/CTMS) and Veeva CDMS Systems

• Author and refine system support processes, operational procedure documents, flow diagrams, configurations, and interdependencies

• Effectively translates business requirements into user stories for the agile development team

• Partner with the business product owner to prioritize the development team’s backlog

• Complete upgrades and enhancements to existing applications

• Provide technical leadership to a team delivering software solutions & release deployments

• Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure

• Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes

• Independently deliver projects and initiatives in a timely and qualitative manor

• Highlight potential risks and act proactively to resolve issues

• Follow company and departmental policies, procedures and ensure documentation according to the Takeda Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards.

• Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability.

• Establish relationships with colleagues across Takeda and analyze issues and guide the
  development of solutions within ongoing processes.

• Build and maintain relationships with key business stakeholders

CORE ELEMENTS RELATED TO THIS ROLE:

• Highly cross-functional role with a broad scope of responsibilities

• High visibility and critical impact on the future of the business

Technical/Functional (Line) Expertise

• Deliver expertise in project delivery approaches, tools, and methodologies

• Provide a comprehensive understanding of the pharmaceutical industry

Leadership

• Inspire, motivate, and drive results

• Clearly and persuasively communicate ideas and data, verbally and in writing

Decision-making and Autonomy

• Provide input to highly complex decisions that impact the overall product roadmap

• Seek diverse input from multiple constituents and stakeholders to drive innovative solutions

• Incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution

Interaction

• Negotiate and resolve conflicts in a constructive manner

• Build strong relationships and collaborate effectively with other interfacing Takeda functions

Innovation

• Recommend, innovate, influence, and implement organizational change and continuous innovation

• Identify opportunities and anticipate changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

• Serve as a role model for respect and inclusion, creating a culture that fosters innovation

Complexity

• Work in a global ecosystem (internal and external) with a high degree of complexity

• Discern and understand a broader, enterprise-level perspective

EDUCATION, BEHAVIORAL COMPETENCIES, AND SKILLS:

Required:

• Bachelor’s degree or equivalent in a science discipline or related field

• 7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions

• Experience in implementing and supporting Veeva Clinical across multiple modules – eTMF, CTMS, Study Startup and Site Connect

• Provide subject matter expertise on the Veeva Systems implementation, Vault R&D product suite, Vault Platform, technical design, and Software as a Service (SaaS) implementation best practices

• Proficient knowledge of Quality Assurance/Compliance, 21 CFR Part 11, and other regulations required

• Proficient in working within an SDLC framework (Delivery, Testing, Software Quality Assurance, Change Management)

• Ability to articulate complex technical problems and solutions to a wide business audience and communicate solution value

• Excellent written/verbal communication skills and presentation and project management skills

• Demonstrated ability to work well within a matrixed environment, and an ability to build solid relationships / make connections across the organization

• Must be able to identify operational weaknesses and implement corrective action/plan

• Experienced in managing projects toward process improvements

Preferred:

• Master’s or higher degree in Computer Science, Scientific Informatics, or related discipline.

• Experience working in R&D and/or Biotech preferred.

• Working knowledge of clinical data systems such as EDC, Clinical Data Management systems, eCOA, IRT, Statistical Analysis Environments, CTMS, and eTMF

• Experience working with global teams remotely

• Familiarity with change control and SDLC associated with computer system validation processes

Base Salary Range: $130,200.00 Range Min to $186,000.00 Range Mid. Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

ADDITIONAL INFORMATION

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.

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.

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