Posted to MedZilla on 8/22/2019

Takeda Pharmaceuticals

US-MA, Medical Device Safety Project Manager R0010567-MZ


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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Safety Project Manager in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Device Safety Project Manager the Pharmacovigilance team, you will be empowered to Innovate and Strategize. A typical day will include:


The Medical Device Safety Project Manager is a position in the Center of Excellence (CoE) for Medical Device Safety of the Global Patient Safety Evaluation. The position will support the mandatory safety reporting requirements for devices used for the delivery of Takeda products. The incumbent will work closely with colleagues in Clinical Development, Technical Operations, Quality Compliance, and the Device Center of Excellence. This position will be based in the Cambridge office.


  • Work closely with the Head of CoE for Medical Device Safety and the Medical Device Safety Specialist to ensure that the CoE for Medical Device Safety deliverables are met
  • Be the liaison for the CoE for Medical Device Safety with internal and external stakeholders, including Device Center of Excellence.
  • Maintain and update the company s devices and combination products and communicate the same to stakeholders.
  • Responsible for identifying activities, monitoring progress, and ensuring timely project delivery for medical safety projects associated with the EU Medical Device Regulation including EUDAMED and supporting technologies including Product Data Management and relational artifact management a required by MDR.
  • Maintain knowledge of relevant regulations and guidance related to devices and combination products to ensure the company is compliant them
  • Creates and maintains all project plans (High-level and detailed project schedule) and presents project status reports to a range of audiences
  • Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion
  • Coordinates with multiple departments to accomplish project objectives by facilitating meetings and follow up activities to ensure timelines are met
  • Coordinates activities concerned with technical developments with Device Center of Excellence and Technical Operations
  • Ensures that all the documents needed for a project are complete per an already established Product Development Procedure
  • Proactively manages changes in project scope, identify potential issues, and devise contingency plans
  • Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization.


  • Bachelor s Degree (or equivalent combination/training and experience)
  • 5 years of project management experience
  • Proven experience applying project management best practices
  • Proficiency with MS Project for planning, monitoring and control, reporting, and critical path analysis
  • High degree of analytical and critical thinking, independent judgment and discretion
  • Superior written and verbal communication skills and the ability to facilitate management and team meetings for issue resolution
  • Demonstrated ability to manage complex network of relationships
  • Experience assembling and leading project teams across multiple functions
  • Experience and/or working knowledge of compliance requirements associated with EU Medical Device Regulation, FDA Unique Device Identification (UDI) and Device Vigilance standards preferred
  • Experience with MS Project, Microsoft Excel, Word, PowerPoint and/or other standardized project management tools/documentation preferred


  • Estimated 5-10 times per year including international travel


  • 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

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Cambridge, MA

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Full time

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