Regulatory Document Coordinator and Training Manager

Axle

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a Regulatory Document Coordinator and Training Manager to join our vibrant team at the National Institutes of Health (NIH) supporting Bethesda, MD.

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  Healthcare (FSA), Parking Reimbursement Account (PRK), Dependent Care Assistant Program (DCAP), Transportation Reimbursement Account (TRN)

This position provides critical support for federal-regulation-mandated documentation and quality control/assurance necessary to operate and maintain NIH's Aseptic Processing Facilities (APFs) and Biosafety Level (BSL) containment facilities. The Regulatory Document Coordinator and Training Manager will manage the full lifecycle of Standard Operating Procedures (SOPs), Work Instructions (WIs), and Training Modules for DFOM's APF and BSL operations — from initial drafting through periodic review, revision, approval routing, controlled distribution, and eventual retirement or archival.

The role maintains detailed version control, authorship, revision history, and approval-status records within NIH's document control system, and monitors document expiration timelines to proactively trigger review or archival.

The position also coordinates cross-functional document reviews with relevant subject matter experts to verify content accuracy and alignment with DFOM policy and applicable regulatory and industry standards, and oversees controlled distribution so that only current, approved document versions remain accessible. In addition, the Coordinator tracks and manages personnel training status in direct linkage with the document control system — linking training modules to their supporting SOPs/WIs, monitoring completion against required time frames, maintaining auditable training records, generating compliance reports, and supporting internal and external audits with documentation of employee qualifications and training adherence.

• SOP/WI/Training Module Master Index & Status Log — Monthly / on-demand
• New/Revised SOP, WI, and Training Module Drafts — As triggered by review cycle or business needli>
• Document Review & Approval of Routing Records — Continuous, reported monthly
• Document Expiration/Review Forecast Report — Monthlyli>
• Controlled Distribution Confirmation Records — Continuousli>
• Personnel Training Status & Training Quiz/Assessment Report — Monthlyli>
• Quarterly Program Status Report — Quarterlyli>
• Annual Program Summary — Annuallyli>
• QMS Account Management Report — Monthlyli>

• Manage initial creation and drafting of new SOPs, Work Instructions, and Training Modules in accordance with DFOM templates and formatting standards
• Coordinate periodic review cycles to ensure documents remain current and technically accurate
• Manage the revision process, including tracking requested changes and incorporating approved edits
• Facilitate the approval process, ensuring required approvers review and sign off within established time frames
• Manage distribution to ensure approved documents reach relevant personnel
• Manage document retirement and expiration, including archival of superseded or obsolete documents
• Utilize the NIH document control system to maintain detailed version control records for all SOPs, WIs, and Training Modules
• Track authorship for each document and revision
• Maintain complete revision history for each…