Synterex is seeking an organized, motivated individual to provide a vision for the future of our document quality control (QC) group. This individual would be responsible for leading the group of QC reviewers, establishing resourcing for all projects across clients, and working directly with Synterex management to provide top-level document QC services to clients.
Essential Duties & Responsibilities
Attend client meetings to understand resourcing needs
Proactively plan for resourcing in a dynamic, data-driven environment
Assist with archiving of essential documents and forms
Review and analyze metrics for QC performance, including accuracy and timing of reviews
Provide GxP-based and editorial QC review of regulatory, clinical, and nonclinical content
Coordinate varied resources based on experience, availability, and geography
Provide project-based training to the QC team and coordinate QC project kickoffs
Collaborate cross-functionally to ensure efficient collection of source documentation, document delivery, and completion of reviews
Bachelor’s degree in a relevant field
5 years of experience in CRO/biotech/pharmaceutical field
Experience in GxP Quality Control supporting drug development
Knowledge of ICH/GxP guidelines
Attention to detail
Service-oriented and proactive approach to document QC coordination
Familiarity with Microsoft applications
Telecommuting is allowed.
About Synterex, Inc.
Synterex, Inc. is a Woman-Owned Small Business (WOSB), Woman-Owned Enterprise (WBE), and Disability-Owned (Disability:IN) consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.