(ID: 2026-3436)

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 the Bethesda, MD

Benefits We Offer:

• 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)

Position Overview

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 timeframes, maintaining auditable training records, generating compliance reports, and supporting internal and external audits with documentation of employee qualifications and training adherence.

Deliverables

• 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 need
• Document Review & Approval of Routing Records — Continuous, reported monthly
• Document Expiration/Review Forecast Report — Monthly
• Controlled Distribution Confirmation Records — Continuous
• Personnel Training Status & Training Quiz/Assessment Report — Monthly
• Quarterly Program Status Report — Quarterly
• Annual Program Summary — Annually
• QMS Account Management Report — Monthly

Statement of Work Details

• 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 timeframes
• 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 controlled document
• Track approval status (pending, approved, rejected, returned for revision) for each document in the workflow
• Record and monitor effective dates for all approved documents
• Monitor document expiration timelines and proactively initiate review or archival processes as review/expiration dates approach
• Coordinate cross-functional reviews involving relevant subject matter experts and stakeholders to ensure document accuracy
• Verify that document content is consistent with current DFOM policies and procedures
• Verify that document content aligns with applicable industry standards and regulatory requirements
• Oversee controlled distribution processes to ensure only the most current, approved versions of documents are accessible to relevant personnel
• Remove or restrict access to superseded or expired document versions
• Link Training Modules to the specific SOPs and WIs they support
• Track individual employee training status against required modules
• Monitor to ensure all employees complete required training within designated timeframes
• Maintain up-to-date, auditable training records for all applicable personnel
• Generate compliance reports summarizing training completion status across DFOM/APF/BSL personnel
• Support internal and external audits by providing documentation of employee qualifications and training adherence upon request

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: [email protected]

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.