Posted 1 month ago
SharePoint Consultant
San Mateo, CARemote
AI Summary
A SharePoint Consultant designs and builds SharePoint-based program management infrastructure for a drug development organization, creating sites, document control workflows, and Power Automate integrations focused on cGXP and IND processes.
About this role
The role: BigHat Biosciences is looking for an experienced and detail-oriented SharePoint Development Consultant to support the design, build-out, and configuration of SharePoint-based program management infrastructure for our drug development organization.
This is a project-based contract engagement, performed remotely through project completion. The consultant will partner directly with our Operations and Program Management teams to build document control workflows, program-facing SharePoint sites, and Power Automate automations that replace manual, email-based document review and adjudication processes.
This work will have a particular focus on cGXP documents, IND-related workflows, and regulatory submission processes.
Key Responsibilities
- Design and build SharePoint program management landing pages that surface program documentation, risk communications, and action items for cross-functional stakeholders
- Integrate Smartsheet outputs or data feeds into SharePoint splash pages to support real-time, redundant visibility into program risks and actions
- Configure document control workflows using SharePoint and Power Automate, including assignment of document authors, reviewers, and adjudicators for IND-related regulatory submissions
- Build automated review and adjudication routing for IND chapter documents (e.g., modules submitted to FDA or ex-US health authorities), replacing manual email-based review chains
- Configure access controls and library permission structures appropriate for a regulated drug development environment
- Provide SharePoint site administration support — including troubleshooting and user access management — on an as-needed basis throughout the engagement
- Lead knowledge transfer and handoff to internal stakeholders upon project completion
- Optionally: assess and recommend opportunities to incorporate Microsoft 365 Copilot or SharePoint AI agent features
Skills, Knowledge & Expertise
- Demonstrated experience designing and building SharePoint sites for program management use cases, ideally in a biotech, pharma, or regulated health sciences environment
- Proficiency in Power Automate workflow configuration within SharePoint
- Hands-on experience with document control systems and regulated document lifecycle management, including IND authoring pipelines or FDA submission workflows
- Working knowledge of SharePoint access controls, library permissions, and compliance-aware configuration
- Experience in clinical or drug development operational settings strongly preferred
- Ability to work independently, manage deliverables across a remote engagement, and communicate clearly with non-technical stakeholders
- A collaborative, solution-oriented approach and comfort operating in a fast-moving startup environment
- Must be based in the United States
Skills
CGxPDocument ControlIND WorkflowsLibrary PermissionsMicrosoft 365 CopilotPower AutomateRegulated Document Lifecycle ManagementSharePointSharePoint Access ControlsSmartsheet
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