Yacht Life Sciences has a vacancy for a Lead Quality Control (QC) Reviewer. For the Medical Writing team of our client, we are looking for a Lead Quality Control (QC) Reviewer who is willing to work from home (from the Netherlands, Belgium, UK, France or Germany).
As a Lead Quality Control (QC) Reviewer, 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 Lead Quality Control (QC) Reviewer:
- 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
- Finished Bachelor or Master degree in a Medical/Scientific field
- > 5 years of Quality Control Experience in the medical writing field
- Good understanding of the pharmaceutical drug development process
- Good working knowledge of International Conference of Harmonization (ICH) and Code of Federal Regulations (CFR) regulatory guidelines
- High proficiency with Windows-based applications and medical/ scientific publication databases/ resources, CTD submission applications, DocX, Quosa, SharePoint
- Ability to manage direct reports
- >3 years project management experience
- Experience with metrics reporting
- Ability to manage multiple priorities and meet deadlines
- Excellent organizational, time-management
- Strong oral and written communication skills
- Team player with excellent interpersonal skills
- Strong detail orientation
This concerns a temporary secondment contract for 1 year (extension is possible) via Yacht, full-time (40h) is required. We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A multinational pharmaceutical company providing innovative medicines in areas of health where there is urgent need for better treatments.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.