Project Coordinator, Regulatory Operations & Compliance

Cambridge, MA, United States
Sep 05, 2018
Required Education
Masters Degree/MBA
Position Type
Full time
bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio's product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinically meaningful options. bluebird bio has three clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD), one for beta-thalassemia major and another for sickle cell disease. bluebird bio is also engaged in an early-stage oncology program including a partnership with Celgene Corporation.

Join bluebird bio's enthusiastic, collaborative team and contribute to the overall success of our novel gene therapy approaches. bluebird bio seeks an outstanding Project Coordinator to support the growing Regulatory Operations and Compliance team. The role will be responsible for coordinating project activities with the Project Manager in the successful submission of major marketing applications to health authorities. It will also be responsible for keeping project schedules on track and ensuring on-time completion of task that impact the success of each project.

Impact on Business
  • Support major department projects and programs ensuring project details are planned, coordinated according to plan, and successfully implemented
  • Aid in the development of Project timelines and maintain in MS Project
  • Coordinate and assist in managing meetings, outcomes and follow ups
  • Follow up with project resources on assigned tasks and status
  • Compile and distribute management summaries, standard reports for communicating task status, and key performance indicators (KPI)
  • Support Regulatory Operations team projects as needed

Innovation and Change
  • Participate in special process improvement projects as requested
  • Make recommendations on improvements to procedures or processes

Other Skills
  • Strong interpersonal and team skills
  • Strong verbal and written communication skills
  • Highly organized and proactive
  • Ability to analyze issues and develop solutions
  • Demonstrated ability to effectively manage multiple priorities and meet deadlines
  • Self-motivated
  • Work independent within a team
  • Strong computer skills; Comprehensive knowledge and experience in MS Office 365 Platform (Project, Word, Excel, PowerPoint, and PowerBI)

  • Bachelor's degree required
  • A minimum of 1 years' experience as a Project Coordinator or Project Management professional
  • Prefer experience in biotech/pharmaceutical industry a plus if experience in Regulator