Digital Regulatory Project Manager

Company: Hornet Staffing
Location: Cambridge
Posted on: June 19, 2022

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