Regulatory Document Coordinator - NIH

Global Solutions Network Inc; Bethesda (MD); On-site; USD 87,000 - 115,000; Full time

Benefits offered by this job

Paid Time Off

Paid Holidays

401K/Profit Sharing Plan

Flexible Spending Accounts

Pretax Parking & Transportation Plan

Short-Term & Long-Term Disability

Life & AD&D Insurance

Professional Development/Education

Employee Discount Program

Employee Assistance Program

Travel Assistance Program

Job summary

Global Solutions Network Inc is seeking a Regulatory Document Coordinator to support NIH. The role involves managing SOPs, WIs, and training modules, ensuring proper version control, approvals, and controlled distribution within the DFOM/BSL environments.

Candidate should have a Bachelor's degree, experience in biomedical labs, and knowledge of GMP regulatory documents, with strong organizational and communication skills.

Qualifications

• Bachelor's degree in a relevant field is required.
• Experience working in biomedical laboratory settings is required.
• Knowledge of regulatory documents related to Good Manufacturing Practice (GMP) is required.
• Strong organizational, written, and interpersonal skills are essential.

Responsibilities

• Document lifecycle management for SOPs, WIs, and Training Modules.
• Coordinate periodic reviews to keep documents current and technically accurate.
• Manage revision tracking and incorporate approved edits.
• Facilitate approvals within established time-frames.
• Distribute documents to ensure access to current versions.
• Archive superseded or obsolete documents.

Skills

Regulatory document management

Attention to detail

Cross-team communication

Education

Bachelor's degree

Job description

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Regulatory Document Coordinator - NIH

Professional Bethesda, MD, US

3 days ago Requisition ID: 1755

Salary Range: $87,000.00 To $115,000.00 Annually

Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

Responsibilities:

1) Document Lifecycle Management

The contractor staff shall manage the full lifecycle of Standard Operating Procedures (SOPs), Work Instructions (WIs), and Training Modules for Division of Facilities Operations and Maintenance (DFOM) Aseptic Processing Facilities (APF) and Biosafety Level (BSL) operations, including:

• Initial creation and drafting of new SOPs, WIs, and Training Modules in accordance with DFOM templates and formatting standards.
• Coordination of periodic review cycles to ensure documents remain current and technically accurate.
• Management of the revision process, including tracking requested changes and incorporating approved edits.
• Facilitation of the approval process, ensuring required approvers review and sign off within established time-frames.
• Management of distribution to ensure approved documents reach relevant personnel (see Requirement Area 3 for controlled distribution specifics).
• Management of document retirement and expiration, including archival of superseded or obsolete documents.

2) Document Control and Records Management

The contractor staff shall utilize the NIH document control system that ensures compliance with organizational and regulatory record keeping requirements, including:

• Maintenance of detailed version control records for all SOPs, WIs, and Training Modules.
• Tracking of authorship for each document and revision.
• Maintenance of complete revision history for each controlled document.
• Tracking of approval status (pending, approved, rejected, returned for revision) for each document in the workflow.
• Recording and monitoring effective data for all approved documents.
• Monitoring of document expiration timelines and proactive initiation of review or archival processes as review/expiration dates approach.

3) Cross-Functional Review Coordination and Controlled Distribution

The contractor staff shall coordinate document review activities and manage controlled access to current documentation, including:

• Coordination of cross-functional reviews involving relevant subject matter experts and stakeholders to ensure document accuracy.
• Verification that document content is consistent with current DFOM policies and procedures.
• Verification that document content aligns with applicable industry standards and regulatory requirements.
• Oversight of controlled distribution processes to ensure that only the most current, approved versions of documents are accessible to relevant personnel.
• Removal or restriction of access to superseded or expired document versions.

4) Personnel Training Management and Compliance Tracking

The contractor staff shall track and manage personnel training status in direct linkage with the document control system, including:

• Linking of Training Modules to the specific SOPs and WIs they support.
• Tracking of individual employee training status against required modules.
• Monitoring to ensure all employees complete required training within designated time-frames.
• Maintenance of up-to-date, auditable training records for all applicable personnel.
• Generation of compliance reports summarizing training completion status across DFOM/APF/BSL personnel.
• Support of internal and external audits by providing documentation of employee qualifications and training adherence upon request.

Qualifications:

• Bachelor's degree in a relevant field.
• Experience working biomedical laboratory settings.
• Demonstrated knowledge of regulatory documents related to Good Manufacturing Practice.
• Strong organizations, written, and interpersonal skills.
• Paid Time Off and Paid Holidays
• 401K/Profit Sharing Plan
• Flexible Spending Accounts (Healthcare & Dependent Care)
• Pretax Parking & Transportation Plan
• Short-Term & Long-Term Disability Insurance
• Life & AD&D Insurance
• Professional Development/Education
• Employee Discount Program
• Employee Assistance Program
• Travel Assistance Program

Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.