Regulatory Documentation & Training Lead

Axle; Bethesda (MD); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Paid Time Off and Paid Holidays

401K match up to 5%

Educational Benefits for Career Growth

Employee Referral Bonus

Flexible Spending Accounts

Job summary

Axle, a bioscience and information technology company, seeks a Regulatory Document Coordinator and Training Manager to support NIH facilities in Bethesda, MD. The role covers SOP/WI/training lifecycle, version control, and cross-functional reviews.

You will ensure compliant document processes, manage approvals, distribution, training linkage, and audit readiness, while maintaining accurate records and timelines across APFs and BSL operations.

Responsibilities

• Draft SOPs, WIs, and Training Modules per DFOM templates
• Coordinate periodic document reviews for accuracy
• Track changes and incorporate approved edits
• Manage document approvals within set timeframes
• Distribute current documents to relevant personnel
• Archive superseded/expired documents
• Maintain version control records in NIH system
• Track authorship and revision history
• Record and monitor document effective dates
• Monitor expiration timelines and trigger reviews
• Coordinate cross-functional reviews for accuracy
• Ensure content aligns with DFOM policies and regulatory standards
• Oversee controlled distribution to current versions only
• Remove access to superseded documents
• Link Training Modules to SOPs/WIs
• Track training status and completion within timeframes
• Maintain auditable training records
• Generate compliance reports for DFOM/APF/BSL personnel
• Support audits with documentation of qualifications and training adherence

Job description

Axle, a bioscience and information technology company, seeks a Regulatory Document Coordinator and Training Manager to support NIH facilities in Bethesda, MD. The role covers SOP/WI/training lifecycle, version control, and cross-functional reviews.

You will ensure compliant document processes, manage approvals, distribution, training linkage, and audit readiness, while maintaining accurate records and timelines across APFs and BSL operations.