SharePoint Consultant
San Mateo, CA - USA
Job Summary
This work will have a particular focus on cGXP documents IND-related workflows and regulatory submission processes.
- 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
- 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
Required Experience:
Contract
About Company
BigHat Biosciences designs safer, more effective biologic therapies for patients using machine learning and synthetic biology. BigHat integrates a wet lab for high-speed characterization with machine learning technologies to guide the search for better antibodies. We apply these desig ... View more