SOP Support - Clinical Operations
Remote · United States
Job Summary
SOP Support - Clinical Operations is a consulting role focused on remediation and compliance for combination products. The consultant will review and assess Clinical Operations SOPs and quality documents (templates, forms, and work instructions), evaluate alignment with combination product development and clinical execution, conduct gap assessments to identify missing or conflicting procedures, and provide remediation recommendations to support compliance, inspection readiness, and operational efficiency. The work requires collaboration across Quality, Regulatory Affairs, Clinical Operations, and other stakeholders, with clear documentation of findings, risk areas, and corrective actions. Qualifications include a Bachelor’s degree, 7+ years in regulated medical device/pharma/biotech/combo products, hands-on SOP review and remediation experience, knowledge of 21 CFR Part 4 and global regulations, and strong communication and technical writing skills.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related discipline
- 7+ years of experience in the medical device, pharmaceutical, biotechnology, or combination products industry
- Demonstrated experience with combination product quality systems and Clinical Operations processes
- Strong working knowledge of 21 CFR Part 4 and applicable global regulations related to combination products
- Hands-on experience performing SOP reviews, gap assessments, remediation activities, and procedural harmonization projects
- Experience supporting global or multi-regional regulatory and quality compliance initiatives
- Familiarity with regional regulatory considerations across the US, EU, UK, Australia, Japan, South Korea, Canada, and Switzerland preferred
- Strong understanding of design controls, risk management, and clinical development processes for combination products
- Excellent technical writing, communication, and stakeholder collaboration skills
- Ability to work independently and provide strategic recommendations in a consulting environment
- Prior experience supporting combination product clinical development programs
- Experience preparing organizations for inspections or regulatory audits
- Background in quality system remediation or quality transformation initiatives
- Experience working within highly regulated environments supporting both device and pharmaceutical requirements
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