Global Medical Device and Testing Firm

Job Description
Software Program Project Manager

Company Description
Our company is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. We designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.

Essential Duties and Responsibilities:

• Own project management activities: timeline management, meeting arrangement, minutes, risk management, partnering activities management, issues resolution and team dynamic management
• Lead a cross functional product development core team in the execution of deliverables. Work closely with RWC, Lab, Quality, Marketing, Regulatory, Medical Affairs and other departments to ensure project priorities and decisions are consistent between teams and corporate strategic plans
• Lead a cross functional joint project team with external partners to align and execute the project per contractual milestones
• Communicate program updates to the core team, to functional management and to executive leadership both internally and externally
• Ensure timely team completion of documents required for the product design history file
• Lead team efforts to mitigate risks and resolve issues quickly as they arise
• Lead the team through problem resolution including root cause analysis and corrective action
• Lead the team to prepare for phase gate reviews and other go/no go decisions required by executive leadership
• Lead the program planning process
• Ensure effective communications with the Core Teams using a variety of tools and channels
• Define program resource needs, negotiate program resourcing plans and track resource usage over the course of the program
• Perform other related duties and assignments as required
Qualifications:
• Bachelor’s degree in a business or a technical discipline. An advanced degree in either business or a technical field is desired. Relevant experience of 4 to 7 years with BS/BA and 3-5 years with Master’s degree
PMP or similar certification is highly desired
• Experience working in team environments is required. Knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, time and cost reporting is required.
• Experience working in MHLW/PMDA-regulated environments is preferable
• Industry experience in medical diagnostics, next-gen sequencing and/or biotech is strong preferred
• Experience leading core teams to successfully launch medical devices or in vitro diagnostic products is highly desired
• Position requires the ability to collect information from multiple sources, sort through, integrate, and resolve often conflicting requirements, and drive an organization through the various issues to result in a successful product launch
• Experience with program management software and PMP certification preferred

Additional Information
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.