George Washington University
Technical Writer
🇺🇸
Hybrid - Rockville, MD
🕑
Full-Time
💰
$64K - $106K
💻
Other
🗓️
March 9th, 2026
FERPA
LMS
Edtech.com's Summary
George Washington University is hiring a Technical Writer for the Biostatistics Center at the Milken Institute School of Public Health. The role involves creating and maintaining detailed technical documentation and managing the Learning Management System to support compliance with FDA, NIH, NIST/FISMA, and SOC standards for multi-center clinical trials and epidemiological studies. The Technical Writer collaborates with various experts to produce regulatory, system, user, process documentation, and training materials for large-scale clinical research projects.
Highlights
- Create and maintain regulatory and compliance documentation meeting FDA and NIH standards.
- Develop system documentation, architecture diagrams, and user training materials.
- Manage the Learning Management System (LMS) with scheduled content reviews.
- Collaborate with subject matter experts to produce IT documentation including policies, procedures, and user instructions.
- Assist documentation related to Software Development Life Cycle (SDLC) and Commercial Off-The-Shelf (COTS) software implementation.
- Use knowledge of FDA 21 CFR Part 11, NIST/FISMA cybersecurity frameworks, and CDISC data standards.
- Preferred experience with statistical software (R, SAS, STATA), clinical trial management systems (REDCap, Medidata, Oracle Clinical), and electronic data capture.
- Bachelor’s degree plus 2 years relevant experience or equivalent; Master’s degree preferred.
- Supports 10-20 concurrent large-scale clinical studies impacting public health nationwide.
- Compensation range: $64,483.58 - $106,415.52 annually.
Technical Writer Full Description
Technical Writer
Please see Special Instructions for more details.
Employer will not sponsor for employment Visa status
Posting Details
I. JOB OVERVIEW
Job Description Summary: | The Biostatistics Center of the Milken Institute School of Public Health is an off-campus medical research center of the George Washington University located in Bethesda, Maryland. The Biostatistics Center (Center) serves as the coordinating center for large scale multi-center clinical trials and epidemiological studies funded by federal agencies including the National Institutes of Health. The Center is a leader in the statistical coordination of major medical research programs of national and international scope. Visit our website at: https://biostatcenter.gwu.edu/ .
The Center seeks an Information Technology (IT) Technical Writer to create and maintain comprehensive technical documentation and oversee our Learning Management System supporting clinical research operations. This hybrid position focuses on developing high-quality documentation that ensures our IT infrastructure and compliance programs meet the rigorous standards required for FDA-regulated clinical trials and NIH-funded research, including NIST/FISMA, and SOC audit requirements. The successful candidate will create documentation that enables regulatory compliance and develop training materials to support multi-million-dollar clinical trials that impact public health nationwide. This role reports to the IT Director and collaborates closely with biostatisticians, data managers, clinical research coordinators, systems administrators, and regulatory specialists to document systems and processes supporting 10-20 concurrent large-scale clinical studies.
Essential duties:
-Regulatory and compliance documentation.
-System documentation and architecture.
-User documentation and training materials.
-Process and procedure documentation.
-Manage the Learning Management System (LMS) and documentation content on a predetermined review cycle.
-Work with subject matter experts (SMEs) to develop IT documentation including policies, procedures, plans, diagrams, and user instructions.
-Assist with documentation related to the Software Development Life Cycle (SDLC) and Commercial Off-The-Shelf (COTS) software evaluation and implementation processes.
-Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Minimum Qualifications: | Qualified candidates will hold a Bachelor’s degree in an appropriate area of specialization plus 2 years of relevant professional experience, or, a Master’s degree or higher in a relevant area of study. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.
Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:
Preferred Qualifications: | Experience in academic biostatistics centers, clinical trial data coordinating centers, or pharmaceutical research environments Knowledge of FDA 21 CFR Part 11 requirements for electronic records and signatures Familiarity with FISMA/NIST cybersecurity frameworks Knowledge of CDISC data standards (SDTM, ADaM, CDASH) Familiarity with statistical software environments (R, SAS, STATA) and their documentation requirements Experience with clinical trial management systems or electronic data capture platforms (REDCap, Medidata, Oracle Clinical) Previous work supporting NIH-funded research or FDA-regulated clinical trials Experience with API documentation and technical specification writing Knowledge of single-source documentation and DITA (Darwin Information Typing Architecture) Proficiency with version control systems and collaborative documentation platforms Experience with video production and e-learning development tools Understanding of research data security requirements (FERPA, 45 CFR 46)
Hiring Range | $64,483.58 - $106,415.52
GW Staff Approach to Pay | How is pay for new employees determined at GW?
The Center seeks an Information Technology (IT) Technical Writer to create and maintain comprehensive technical documentation and oversee our Learning Management System supporting clinical research operations. This hybrid position focuses on developing high-quality documentation that ensures our IT infrastructure and compliance programs meet the rigorous standards required for FDA-regulated clinical trials and NIH-funded research, including NIST/FISMA, and SOC audit requirements. The successful candidate will create documentation that enables regulatory compliance and develop training materials to support multi-million-dollar clinical trials that impact public health nationwide. This role reports to the IT Director and collaborates closely with biostatisticians, data managers, clinical research coordinators, systems administrators, and regulatory specialists to document systems and processes supporting 10-20 concurrent large-scale clinical studies.
Essential duties:
-Regulatory and compliance documentation.
-System documentation and architecture.
-User documentation and training materials.
-Process and procedure documentation.
-Manage the Learning Management System (LMS) and documentation content on a predetermined review cycle.
-Work with subject matter experts (SMEs) to develop IT documentation including policies, procedures, plans, diagrams, and user instructions.
-Assist with documentation related to the Software Development Life Cycle (SDLC) and Commercial Off-The-Shelf (COTS) software evaluation and implementation processes.
-Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Minimum Qualifications: | Qualified candidates will hold a Bachelor’s degree in an appropriate area of specialization plus 2 years of relevant professional experience, or, a Master’s degree or higher in a relevant area of study. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.
Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:
Preferred Qualifications: | Experience in academic biostatistics centers, clinical trial data coordinating centers, or pharmaceutical research environments Knowledge of FDA 21 CFR Part 11 requirements for electronic records and signatures Familiarity with FISMA/NIST cybersecurity frameworks Knowledge of CDISC data standards (SDTM, ADaM, CDASH) Familiarity with statistical software environments (R, SAS, STATA) and their documentation requirements Experience with clinical trial management systems or electronic data capture platforms (REDCap, Medidata, Oracle Clinical) Previous work supporting NIH-funded research or FDA-regulated clinical trials Experience with API documentation and technical specification writing Knowledge of single-source documentation and DITA (Darwin Information Typing Architecture) Proficiency with version control systems and collaborative documentation platforms Experience with video production and e-learning development tools Understanding of research data security requirements (FERPA, 45 CFR 46)
Hiring Range | $64,483.58 - $106,415.52
GW Staff Approach to Pay | How is pay for new employees determined at GW?
Healthcare Benefits
GW offers a comprehensive benefit package that includes medical, dental, vision, life & disability insurance, time off & leave, retirement savings, tuition, well-being and various voluntary benefits. For program details and eligibility, please visit https://hr.gwu.edu/benefits-programs.
GW offers a comprehensive benefit package that includes medical, dental, vision, life & disability insurance, time off & leave, retirement savings, tuition, well-being and various voluntary benefits. For program details and eligibility, please visit https://hr.gwu.edu/benefits-programs.
II. JOB DETAILS
Campus Location: | Rockville, Maryland
College/School/Department: | The Biostatistics Center
Family | Comm, Mktg & Media
Sub-Family | Writing and Editing
Stream | Individual Contributor
Level | Level 2
Full-Time/Part-Time: | Full-Time
Hours Per Week: | 40
Work Schedule: | Monday-Friday, 9am-6pm
Will this job require the employee to work on site? | Yes
Employee Onsite Status | Hybrid
Telework: | Yes
Required Background Check: | Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search
Special Instructions to Applicants: | Employer will not sponsor for employment Visa status
Internal Applicants Only? | No
Posting Number: | S014073
Job Open Date: | 03/02/2026
Job Close Date: |
If temporary, grant funded, Sponsored Project funded or limited term appointment, position funded until: |
Background Screening | Successful Completion of a Background Screening will be required as a condition of hire.
EEO Statement: | The university is an Equal Employment Opportunity employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.
College/School/Department: | The Biostatistics Center
Family | Comm, Mktg & Media
Sub-Family | Writing and Editing
Stream | Individual Contributor
Level | Level 2
Full-Time/Part-Time: | Full-Time
Hours Per Week: | 40
Work Schedule: | Monday-Friday, 9am-6pm
Will this job require the employee to work on site? | Yes
Employee Onsite Status | Hybrid
Telework: | Yes
Required Background Check: | Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search
Special Instructions to Applicants: | Employer will not sponsor for employment Visa status
Internal Applicants Only? | No
Posting Number: | S014073
Job Open Date: | 03/02/2026
Job Close Date: |
If temporary, grant funded, Sponsored Project funded or limited term appointment, position funded until: |
Background Screening | Successful Completion of a Background Screening will be required as a condition of hire.
EEO Statement: | The university is an Equal Employment Opportunity employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
Documents needed to Apply
Required Documents
- Resume
- Cover Letter
Optional Documents
Human Resource
Management & Development
Management & Development
2013 H Street, NW, 3rd Floor
Washington, DC 20006
Phone: 202-994-8500
Fax: 202-994-9680
Email: askhrmd@gwu.edu
Recognition_Toolkit
Talent@GWLogin
Washington, DC 20006
Phone: 202-994-8500
Fax: 202-994-9680
Email: askhrmd@gwu.edu
Recognition_Toolkit
Talent@GWLogin
Similar Jobs
Associate Dean for Strategic Partnerships and Workforce Advancement - 528786
University of Alabama
🇺🇸 Tuscaloosa, AL
Crimson Scholars Program Coordinator I - 528501
University of Alabama
🇺🇸 Tuscaloosa, AL
Editorial Writer and Content Strategist
Illinois State University
🇺🇸 Normal, IL
Supervisor, Writing & AI Literacy Services
College of Western Idaho
🇺🇸 Nampa, ID
Provost/Vice President, Academic Affairs
West Valley College
🇺🇸 Saratoga, CA
