Randstad Professional has a vacancy for a Senior Quality Control Reviewer willing to work from home.
The primary role of the Senior Quality Control Reviewer is to perform scientific quality review of regulatory documents to ensure data integrity and compliance with applicable regulatory requirements.
Furthermore:
- Performing quality reviews of global regulatory documents and submissions including: clinical study reports (CSR), CSR appendices, CSR amendments, synopses, patient narratives, statistical analysis plans, investigator brochures, Investigational Medicinal Product Dossiers (IMPDs) and Common Technical Documents (CTDs) for content and data accuracy with sources.
- Reviewing document text, as required in consistency documentation, to ensure that all documents meet designated requirements for formatting, consistency, grammar, style guidelines and publishing guidelines.
- Effectively project managing multiple medical writing QC projects, meeting deliverable dates and ensuring quality documents per client’s SOPs
- Performing electronic quality control check (eQC) per clients SOPs ensuring hyperlinks work correctly and literature references are linked properly.
Apply now and receive a WhatsApp message within 15 minutes with a few short questions, so we can help you quickly.
Don't have WhatsApp? We'll contact you by phone or email!
Functie-eisen
- Minimum of 4 years of Quality Control Experience in the medical writing field for the pharmaceutical industry
- Understanding of the pharmaceutical drug development process
- Experience with a broad range of regulatory documents and if possible disclosure documents
- Good working knowledge of ICH and CFR regulatory guidelines
Competenties
- High proficiency with Windows-based application and medical/scientific publication databases/resources, CTD submission applications, DocX, Quosa, and SharePoint
- Ability to manage multiple priorities and meet deadlines
- Excellent organizational, time-management, and project management skills
- Strong oral and written communication skills
- Team player with excellent interpersonal skills
- Strong detail orientation
- Willing to work from home and must be located in Europe
Arbeidsvoorwaarden
We will offer a competitive benefits package in line with the seniority of the position. This is a full-time position (32h or 36h per week can be discussed).
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 network of Randstad professional, which stretches the Life Science industry.
Bedrijfsinformatie
A multinational pharmaceutical company providing innovative medicines in areas of health where there is urgent need for better treatments.
Good to know: You'll receive a WhatsApp message from us within 15 minutes of applying. We'll ask you a few short questions about your application to help you more quickly. Don't have WhatsApp? No problem! We'll contact you by phone or email.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Anastassia Blechko
anastassia.blechko@randstadprofessional.nl
06-53941731
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Je sollicitatie en cv worden doorgenomen door Anastassia Blechko
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