Digital Regulatory Project Manager
Company: Hornet Staffing
Location: Cambridge
Posted on: June 19, 2022
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Job Description:
The Role:
As a Digital Regulatory Project Manager, you will spearhead the
execution of digital for regulatory projects in support of Digital
roadmap. In this role, you will collaborate with various
stakeholders and contributors from regulatory operations, medical
writing, and regulatory strategy to advance digital projects for
regulatory.
This role will report into the Principal Project Manager, Clinical
Informatics.
Here's What You Will Do:
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Act as the project manager for structured content authoring (SCA)
platform deployment:
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
Here's What You Will Bring to the Table:
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.
Keywords: Hornet Staffing, Cambridge , Digital Regulatory Project Manager, Executive , Cambridge, Massachusetts
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