Auf einen Blick
- Aufgaben: Überprüfe und verbessere medizinische Dokumente für klinische Studien.
- Unternehmen: Innovatives Bio-Pharma-Unternehmen mit Sitz in der Schweiz.
- Vorteile: 2 Jahre Vertrag mit hoher Möglichkeit auf Verlängerung oder Festanstellung.
- Weitere Informationen: Dynamisches Umfeld mit Möglichkeiten zur beruflichen Weiterentwicklung.
- Warum dieser Job: Gestalte die Zukunft der Medizin durch hochwertige Dokumentation.
- Qualifikationen: Mindestens 7-10 Jahre Erfahrung in medizinischem Schreiben oder Qualitätssicherung.
Das prognostizierte Gehalt liegt zwischen 99000 - 121000 CHF pro Jahr.
Medical Writer Documentation Specialist - 7103Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for an experienced Medical Writer Documentation Specialist to act as a subject matter expert for the quality of clinical, nonclinical, and regulatory documentation.
The role ensures that key deliverables are clear, accurate, consistent, compliant, and submission-ready, supporting development programs, health authority interactions, and global regulatory submissions.
This is a 2 years' contract based in Basel area with high possibilityof extension(s) or turning into a permanent role.
Main
Responsibilities: Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with internal procedures, templates, ICH guidance, and relevant health authority requirements.
Ensure documents are suitable for inclusion in critical regulatory submissions, including NDA, MAA, CSR, DSUR, and IND dossiers.
Partner with authors, contributors, and cross-functional stakeholders to continuously improve the quality of clinical and regulatory documents.
Contribute to the development and implementation of documentation templates, guidelines, standards, and best practices.
Manage collaboration with external documentation quality specialists, including work allocation, quality oversight, and timely delivery of outputs.
Coach and mentor external consultants and colleagues developing expertise in documentation quality control.
Support due diligence activities when required.
Qualifications and
Experience: Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required; Master's degree or equivalent qualification required; a science-related discipline is preferred.
At least 7-10 years of relevant experience in clinical and/or nonclinical quality assurance, medical or regulatory writing, or the editing and quality review of clinical and nonclinical documents.
Strong knowledge of regulatory documentation requirements, guidelines, submission standards, and document quality expectations.
Good understanding of experimental methods, research design, and statistical analysis.
Ability to analyze and interpret medical data generated in clinical trials.
Excellent attention to detail, accuracy, judgement, and quality orientation.
Ability to work independently, manage priorities, and deliver effectively within tight timelines.
Excellent communication and interpersonal skills, with confidence working across functions and with external partners.
Fluency in English, additional European Languages an advantage #J-18808-Ljbffr
Medical Writer Documentation Specialist – 7103 in Basel Arbeitgeber: CTC Resourcing Solutions
Unser Kunde bietet eine dynamische und unterstützende Arbeitsumgebung am Hauptsitz in Bern, wo Teamarbeit und Innovation gefördert werden. Als QA Associate haben Sie die Möglichkeit, aktiv zur Verbesserung von Qualitätsprozessen beizutragen und sich in einem spezialisierten Bereich der Biotherapeutika weiterzuentwickeln. Das Unternehmen legt Wert auf kontinuierliche Weiterbildung und bietet zahlreiche Möglichkeiten zur beruflichen Entfaltung, während es gleichzeitig ein starkes Engagement für die Patientenversorgung zeigt.
