Remote Clinical Regulatory QC Specialist

The Fountain Group; New York (NY); Hybrid; USD 62,000 - 66,000; Full time

Job summary

The Fountain Group is seeking a Quality Control Specialist to support the review and verification of clinical regulatory documents within the Medical Writing department, ensuring accuracy, compliance, and consistency for regulatory submissions.

This remote, 6–12 month contract involves collaborating daily with medical writers and regulatory teams to perform QC checks, verify data against source materials, and prepare submissions with appropriate templates.

Qualifications

• 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.

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.

Skills

Attention to detail

Analytical skills

Communication

Organizational skills

Cross-functional collaboration

Education

Bachelor’s degree

Job description

The Fountain Group is seeking a Quality Control Specialist to support the review and verification of clinical regulatory documents within the Medical Writing department, ensuring accuracy, compliance, and consistency for regulatory submissions.

This remote, 6–12 month contract involves collaborating daily with medical writers and regulatory teams to perform QC checks, verify data against source materials, and prepare submissions with appropriate templates.