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Digital Regulatory Project Manager

Katalyst Healthcares & Life Sciences
Cambridge, MA Contractor
POSTED ON 11/24/2023 CLOSED ON 12/14/2023

Job Posting for Digital Regulatory Project Manager at Katalyst Healthcares & Life Sciences

Responsibilities:
  • Identify project deliverables such as content model and taxonomy, components artifacts
  • Monitor and manage project risks as needed
  • Facilitate governance meetings and status updates
  • Coordinate activities and timelines with external vendors and Digital Centers of Excellence (Cloud operations, cyber security)
  • Lead Artificial Intelligence (AI) projects in for regulatory in collaboration with our Data Science and AI team:
  • Collect and organize AI project artifacts
  • Work with AI team to scope and assign the relevant project team members
  • Lead Integration projects which entail a solid understanding of different technical workstreams and dependencies and incorporate them in overall project timelines
  • Establish and manage project timelines and project deliverable.
  • Work collaboratively across the organization to gain alignment on project goals and deliverables
  • Engage with Computer Systems Validation team to support validation activities (as needed)
  • Report on projects progress and status
Requirements:
  • 7 years' experience in digital project management (GxP experience a plus)
  • Proven experience with Regulatory processes and platforms (Veeva preferred).
  • Tangible record of accomplishment in using Agile approaches in a regulated environment
  • As a technologist, you know your craft and you are fluent in the digital world. You have first-hand knowledge of SaaS (Software as a Service) technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.
  • You have a working knowledge of regulatory business processes in a drug development context
  • You work independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive projects forward.
  • You do not hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity and lead a team effectively
  • You put team before tasks by collaborating actively with all team members and supporting them.
  • Bachelor's degree in Computer Science, Biotechnology or equivalent required.
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