Quality Review Specialist

Responsibilities

• Perform periodic TMF Quality Reviews for assigned projects to ensure completeness and audit readiness
• Generate and file TMF documentation related to periodic Quality Reviews
• Monitor and escalate document processing issues, inconsistencies, or missing documents to the TMF Lead
• Support updates to expected documents and opening of placeholders in the TMF
• Identify potential training needs for team members to encourage high-quality TMF maintenance
• Identify and escalate studies at serious risk based on poor quality

Requirements

• Bachelor’s degree or international equivalent
• 2 years of related experience
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
• Experience with eTMF systems and vendors
• Working knowledge of FDA and ICH/GCP regulations and guidelines

Preferred Qualifications

• Ability to work independently and as part of a team
• Strong organizational and time management skills
• Excellent verbal and written communication skills

About the Company

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, helping pharmaceutical and life-sciences clients conquer product development and commercialization challenges.