Posted to MedZilla on 11/14/2019

Takeda Pharmaceuticals

US-MA, Inspection Readiness & Sponsor Oversight Mgr R0013008-MZ


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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Inspection Readiness & Sponsor Oversight Manager in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.


  • Manage development and implementation of new sponsor oversight capability for GDO
  • Manage development and execution of strategy and process changes required to ensure compliance with ICH E6 R2; maintain and/or evolve associated risk assessment tools and processes as required
  • Manage Inspection Readiness Activities, including development of processes and tools related to Sponsor Oversight at CROs and third party vendors; support Clinical Operations and other GDO functions to ensure appropriate documentation is in place and assess compliance
  • Manage oversight of compliance with sponsor oversight activities via review of documentation and metrics


  • Manage development of strategy and implementation for new sponsor oversight capability
  • Manage the development of strategies and measurable action plans with GDO functions to ensure compliance with ICH E6 R2; support maintenance of risk assessment tools and processes
  • Manage and/or lead Inspection Readiness planning and execution in partnership with CQA
  • Manage development of strategy and plans for targeted, centralized reviews for monitoring oversight
  • Contribute to efforts for establishing and maintaining risk based monitoring approach for Takeda R&D including evaluating methodology and technology to support oversight
  • Create documentation, such as plans, timelines, progress reports, measuring oversight compliance and quality communicating actions to stakeholders
  • Identify and highlight risks and issues within project(s) and escalate appropriately. Identify, develop, and implement effective mitigation and escalation strategies for projects to address risks and issues
  • Work with internal and external stakeholders as needed to share capability and operational framework
  • Represent GDO on inspection and oversight activities/initiatives
  • Present on oversight and associated plans, quality metrics as needed to a variety of audiences
  • Active participation on oversight/IR team ensuring timely completion of deliverables as per agreed upon timelines
  • Manages identification and implementation of improvements to optimize Sponsor Oversight, Inspection Readiness and ICF E6 R2 compliance
  • Ensure trial oversight compliance for GDO according to all company and departmental policies, procedures, and standards
  • Develop, contribute and support the implementation of change programs supporting the overall project


  • Solid project management and problem-solving skills with the ability execute on plans with limited direction and support
  • Proven conceptual thinking and strategic problem-solving ability
  • Ability to prioritize and lead various team members at various levels to achieve goals
  • People management skills
  • Strong communication skills
  • Strong strategic and analytical thinking
  • Solid knowledge and experiences with GCP regulatory inspections
  • Proven ability to adapt to change and manage cultural change in an evolving environment.


  • Minimum of 8+ years clinical research experience in pharmaceutical or biotechnology field
  • Solid knowledge of clinical trials management and clinical trial lifecycle and processes
  • Experience in problem solving, negotiations and collaborative team-building with non- direct reports and other stakeholders is required
  • Comprehensive knowledge of regulatory requirements governing clinical trials and industry best practices
  • BS, MS or equivalent in scientific field


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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

Empowering Our People to Shine

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Boston, MA

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Full time

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