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Posted: 10/15/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory compliance for consent forms, with a strong foundation in technical and medical writing. Proficient in editing and quality control, while maintaining knowledge of human subject protections and relevant regulations.
Highest-signal resume keywords
Regulatory ComplianceTechnical/Medical WritingEditing Consent FormsHuman Subjects Research TrainingCertified IRB Professional (CIP)
About the role
Key responsibilities & impact- Conduct accurate pre-review of new and revised consent forms for regulatory compliance with FDA, HHS, Health Canada, TCPS2, and ICH GCP requirements and Advarra procedures
- Edit new and revised consent forms for regulatory compliance and alignment with Advarra standards
- Apply negotiated sponsor and site language documented in mandatory language documents
- Collaborate with Board members and staff to incorporate necessary stakeholder edits
- Complete informed consent quality-control checks for personal and team documents
- Mentor new team members as requested
- Maintain and increase regulatory knowledge related to human subject protections, drug, device, and cosmetic research
- Complete recurring Human Subjects Research Training, such as CITI
- Complete organizational training as required
- Attend one IRB meeting monthly, or two monthly during initial training
- Offer process-improvement suggestions to management
- Perform other duties as assigned
Requirements
What you’ll need- 2+ years of experience in technical/medical writing and/or editing
- Bachelor’s degree
- Experience writing and/or editing consent forms or other research documents
- Proficiency in word processing and editing, including Tracked Changes and Compare Merge functions
- Familiarity with Excel, PowerPoint, Slack or similar direct messaging applications, Zoom or RingCentral or similar remote meeting applications, and web-based proprietary software
- Ability to communicate clearly and professionally in English, verbally and in writing
- Preferred: 1+ years of IRB experience
- Preferred: Certified IRB Professional (CIP) or completion of CIP within two years of eligibility
- Knowledge of U.S. and/or Canadian regulations and guidelines concerning human subject protections, drug research, device research, and cosmetic research
- Familiarity with scientific/medical terminology and ability to convert scientific/medical information to lay terms
- Ability to edit technical and/or medical documents
- Ability to read and comprehend advanced technical/medical documents, including medical protocols and informed consent forms
- Ability to manage multiple editing projects under conflicting demands and priorities
- High attention to detail, accuracy, thoroughness, and problem-solving skills
- Ability to follow written and verbal instructions and work independently
- Must be able to sit or stand for extended periods at a stationary workstation
- Must regularly carry, raise, and lower objects up to 10 lbs.
Benefits
Comp & perks- Variable bonus eligibility in addition to base salary
- Health coverage
- Paid holidays
- Other benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical WritingEditingQuality ControlRegulatory KnowledgeMedical TerminologyDocument ManagementAttention to DetailProblem-SolvingProject Management
Soft Skills
Clear CommunicationMentoringCollaborationIndependence
Tools & Technologies
Word ProcessingExcelPowerPointSlackZoomRingCentralWeb-Based Software
Certifications & Qualifications
Certified IRB Professional (CIP)
Industry Keywords
FDAHHSHealth CanadaICH GCPHuman Subject ProtectionsDrug ResearchDevice ResearchCosmetic ResearchIRB Experience