Beschreibung
Document Quality Manager (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Perform source data verification and technical quality control (QC) of submission documents (simple to medium complexity) to ensure adherence to content and format quality standards. Collaborate with globally located scientific and operational personnel, to ensure finalization of the documents, according to timelines and quality requirements.
- Provide advice when required to authors on requirements, technical formatting processes and the use of Novartis’ document management systems.
- Compile, integrate and publish applicable documents with word processing, electron-ic publishing, and document management systems in collaboration with the responsible au-thor(s).
- Work with external consultants (vendors) to coordinate outsourced activities related to the processed tasks.
- Serve as a Business Administer for the Non-Clinical documentation repository, thus providing support for new user account creation and troubleshooting of routine system workflow issues.
- May contribute to the generation of ideas on areas for optimization and innovation and assist in process improvement activities related to document quality management and submission management.
- Support with Merger and Acquisition actives, as it relates to the integration of acquired assets/documents into electronic Document Management Systems.
- May provide input to DQM onboarding and training materials.
Main qualifications
- Undergraduate degree preferably in a scientific discipline or business vocation or equivalent work experience.
- Elevant work experience with electronic document management systems (Documentum, Veeva Vault etc.) and document review.
- Basic understanding of non-clinical, clinical and regulatory deliverables relevant to submission dossiers.
- Demonstrated ability to work successfully within a matrix environment and influence cross functional teams.
- Flexible and detail-oriented approach to documenta-tion management, as appropriate.
- Experience with and ability to understand compliance practices which include GxPs and Standard Operating Procedures.
- Strong oral and written communication skills and customer service mindset.
- Proficient in the use of Microsoft office suite (e.g. MS Word, Excel, PowerPoint).
- Self-starter with a proven ability to prioritize work, multi task, display customer centricity and manage time appropriately, in a fast paced/high volume environment.
Main advantages:
- International company
About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
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