Yacht Life Sciences has a vacancy for a Quality Control (QC) Manager. For the Medical Writing team of our client, we are looking for a QC Manager who is willing to work from home (from the Netherlands, Belgium, UK, France or Germany).

As a QC Manager, your primary role is to perform scientific quality review of regulatory documents to ensure data integrity, and compliance with applicable regulatory requirements. Furthermore, you are responsible for QC workload oversight and assignments, ensuring all work has been assigned and deliverable dates met. Also, you will manage QC Reviewers and ensures staff is meeting expectations.

Responsibilities:

• Manage QC workload and assignments ensuring all work is assigned and deliverables met
• Manage QC Reviewers, has oversight for staff and ensures staff are meeting expectations
• Perform quality reviews of global regulatory documents and submissions including: clinical study reports (CSR), CSR appendices, CSR amendments, synopses, protocols, protocol amendments, synopses, investigator brochures, Investigational Medicinal Product Dossiers (IMPDs) and Common Technical Documents (CTDs) for content and data accuracy with sources
• Review document text, as required in consistency documentation, to ensure that all documents meet designated requirements for formatting, consistency, grammar, style guidelines and publishing guidelines
• Ability to effectively project manage medical writing QC workload and projects, meeting deliverable dates and ensuring quality documents per client’s SOPs
• Perform electronic quality control check (eQC) per clients SOPs ensuring hyperlinks work correctly and literature references are linked properly.
• Attend management and client meetings as required