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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.

The Senior Director, GRA OCM, Training & Knowledge Management is a senior strategic leader within Global Regulatory Affairs (GRA), responsible for shaping and executing the vision for organizational change, capability development, and knowledge stewardship across the regulatory function. Reporting to the Executive Director, Head of Operational Excellence, this role drives enterprise-aligned transformation by embedding change management strategies, scalable training programs, and centralized knowledge systems that enable regulatory excellence and operational agility.

As a key partner to cross-functional teams, including the GRA Initiatives PMO, GRA Center of Excellence, and GRA Compliance—the Senior Director ensures that change initiatives are effectively communicated, adopted, and sustained. This role also leads the development of role-based learning frameworks, AI-enhanced training content, and the GRA Academy, fostering a culture of continuous learning and improvement. The ideal candidate brings deep expertise in regulatory operations, strategic delivery, and people leadership, with a proven ability to influence at all levels of a global matrixed organization.

How you will contribute:

• Lead GRA’s representation in the R&D Change Management Coalition, sharing methodologies and best practices with the GRA Community.

• Develop and oversee execution of change management strategies for GRA and enterprise-level initiatives.

• Guide change management and communications planning and delivery for change initiatives, including awareness sessions, hypercare, and stakeholder engagement.

• Own the training profile and assignment management process, ensuring alignment with role-based learning and regulatory requirements.

• Drive the development of eLearning content and functional guides, integrating AI-driven summaries and Veeva QualityDocs binders.

• Own and further curate the GRA Academy as a centralized SharePoint library of training materials and knowledge assets.

• Collaborate with PMO and Business Process Office (BPO) leads to ensure change management and training strategies are embedded in project planning and execution.

• Define and monitor KPIs for training effectiveness and change adoption, including risk tracking for delayed implementations.

• Serve as a key partner to GRA Compliance for continuous improvement and CAPA resolution.

Minimum Requirements/Qualifications:

• Bachelor’s degree in Life Sciences, Business, or related field; advanced degree preferred.

• 12+ years of experience in pharmaceutical/biotech industry, with 8+ years in regulatory affairs, change management, or learning development.

• Demonstrated success in leading OCM and training functions within a global matrix organization.

• Experience in applying change management methodologies (ADKAR, Kotter, Prosci, etc.).

• Experience with Veeva, SuccessFactors LMS, and SharePoint-based knowledge systems.

• PMP or equivalent certification preferred.

• Strategic Leadership: Ability to set vision and direction for change management, training, and knowledge initiatives aligned with GRA and enterprise goals 

• Organizational Influence: Skilled in engaging senior leaders and driving consensus across diverse stakeholder groups, especially in matrixed environments 

• Change Leadership: Expertise in leading organizational change, embedding agile methodologies, and fostering adoption of new initiatives across GRA and enterprise programs 

• Business Acumen: Deep understanding of regulatory affairs, enterprise strategy, and operational excellence frameworks 

• Project & Portfolio Management: Ability to manage complex initiatives, including training rollout, knowledge asset curation, and change adoption tracking

• Storytelling & Communication: Proficient in crafting compelling narratives to convey strategic value, change rationale, and training impact 

• Training Strategy & Execution: Skilled in designing role-based learning paths, developing eLearning content, and managing training profiles and assignments 

• Knowledge Management: Ability to curate and maintain centralized repositories like the GRA Academy, integrating AI-driven summaries and functional guides 

• Digital Dexterity: Comfortable leveraging digital tools (e.g., Veeva QualityDocs, AI summarization) to enhance training delivery and knowledge access 

• Analytical Thinking: Capable of synthesizing data and insights to inform decision-making, especially around KPIs for training effectiveness and change adoption 

• Continuous Improvement: Experience in CAPA resolution, risk tracking, and embedding feedback loops into training and change management processes 

• Talent Development: Commitment to mentoring and growing high-performing teams, including instructional designers and change agents 

• Stakeholder Engagement: Ability to build trust and collaboration across functions, including the GRA senior leadership, PMO, Compliance, and Business Process Excellence teams 

• Adaptability & Resilience: Demonstrated ability to navigate evolving priorities, resource constraints, and organizational transitions.

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 "remote" following Takeda's Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$208,200.00 - $327,140.00

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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