Quality is not an act, it's a habit.
Over de functie
For our client, a multinational pharmaceutical company, Yacht Life Sciences is looking for a senior Quality Control (QC) Reviewer willing to work from home.
The primary role of the QC Reviewer is to perform scientific quality review of regulatory documents to ensure data integrity and compliance with applicable regulatory requirements.
- Perform 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.
- 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 multiple medical writing QC 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.
- Bachelor/ Master Degree
- Understanding of the pharmaceutical drug development process
- Minimum of 4 years of Quality Control Experience in the medical writing field for the pharmaceutical industry
- Experience with a broad range of regulatory documents and if possible disclosure documents
- Good working knowledge of ICH and CFR regulatory guidelines
- 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
If you match our criteria, please send in your motivation and resume. Based on the incoming applications, we select and invite candidates for an interview.
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.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.