Quality Control Specialist – Clinical Regulatory Documentation
Location: Remote
Contract Length: 6–12 months
Pay Rate: $45–$48/hour (based on experience)
Overview
We are seeking a Quality Control Specialist to support the review and verification of clinical regulatory documents within the Medical Writing department. The ideal candidate will ensure accuracy, compliance, and consistency of regulatory submission materials, working closely with medical writers, regulatory teams, and cross-functional stakeholders to uphold documentation quality standards and business processes.
Key Responsibilities
- Define the scope of quality control activities with document authors and identify required source documents and data.
- Conduct independent QC reviews of regulatory documents per established checklists, verifying data accuracy against source materials.
- Ensure QC documentation is complete, accurate, and uploaded to the master file per established business processes.
- Maintain strong working knowledge of clinical regulatory documents and relevant business processes.
- Collaborate daily with medical writers and medical writing managers to review deliverables, communicate findings, and ensure timely completion of QC activities.
- Support preparation and inspection of technical documents for both domestic and international regulatory submissions, incorporating text, graphs, charts, tables, and statistical content as needed.
- Proofread, edit, and compile product submissions ensuring adherence to templates and style standards.
- Operate independently with limited oversight, effectively managing multiple projects and competing priorities.
Qualifications
- Education:
- Bachelor’s degree required; preferred fields include Science, English, or Communications.
- Experience:
- 2–3 years of relevant industry experience in quality control/review of clinical regulatory documents, or related areas such as quality assurance, clinical research, medical writing, regulatory affairs, or product development/R&D.
- Higher education may offset required years of experience, and vice versa.
- Technical Skills:
- Strong understanding of the organization and content of clinical documents, including eCTD structure and Common Technical Document (CTD) templates.
- Familiarity with regulatory submission standards and drug development processes.
- Core Competencies:
- Exceptional attention to detail, analytical and critical-thinking skills.
- Excellent written and verbal communication; strong interpersonal and organizational skills.
- Ability to manage conflict and prioritize multiple tasks/projects.
- Demonstrated success working cross-functionally in collaborative team environments.