Senior Business Systems Analyst, IT R&D Systems - Regulatory Affairs

Cambridge, MA

Description

bluebird bio seeks an outstanding Business Systems Analyst or Senior Business Systems Analyst, IT R&D Systems - Regulatory Affairs.  Reporting to the Associate Director of IT R&D, the primary function of this role will be to partner with the Regulatory Ops Business Owner to provide support in managing both ongoing and future projects within the Regulatory Affairs Portfolio. This will initially include but not be limited to: RIMS, Submissions Authoring, Publishing and Validation, and Electronic Submissions Gateway. We are interested in self-motivated candidates requiring little supervision, that embrace learning within challenging circumstances, and who will thrive in a fast-paced, dynamic environment.

Experience Qualifications

  • BS/BA; MBA preferred
  • 5-8+ years overall experience in drug development with at least 3 years program management experience in the biopharmaceutical industry
  • Experience in Regulatory Operations in a drug development environment.

Capabilities and Qualifications

  • Knowledge/experience in managing/implementing GxP projects and systems. Experience working within the framework of a validated project implementation plan and knowledge of validation deliverables
  • Knowledge/experience in working with Regulatory Information Management Systems, document management systems, authoring, validation and publishing tools.
  • Ability to effectively partner with Business Process Owners in driving project selection and implementation through effective gathering and analysis of user requirements and capabilities needs.

Key Responsibilities

  • Manage solution selection process through appropriate levels of due diligence (RFI or RFP)
  • Oversee contracting and negotiations, and manage product vendor
  • Manage a project team through the project lifecycle, providing guidance and support as necessary through all phases. Track and manage project using PMO tools ensuring that projects are delivered in a timely fashion within budget
  • Manage and track validation deliverables (risk assessments, validation plans, etc) through the project implementation period
  • System Administration - onboarding via SSO (R/O users)
  • Change Management / Configuration management- system upgrades (review release notes, risk assessment or change control as required)
  • Work in concert with the user community to actively manage and optimize solutions through their lifecycle
  • Work and manage external consultants as needed
  • Manage initiative/project portfolio and meet regularly with Business Sponsor/Owner to review initiatives and their respective budget/timeline/resources for prioritization.
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