Document Quality Specialist (5177)
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Document Quality Specialist –(5177-LBD)
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an Document Quality Specialist for 12 month contract role with the possibility for a extension based in Basel, Switzerland. This is a hybrid role.
This purpose of the role is to perform assessment, quality control and publishing of scientific documents to ensure consistency with source data and to achieve the technical quality to comply with internal and external guidelines and requirements. Collaborate with external service providers as related to areas of responsibility. Collaborate to support timely compilation of high-quality submissions for Global Health Authorities.
- Perform source data verification (SDV) and technical (Novstyle) quality control (QC) of submission documents (simple to medium complexity) to ensure both content and format fulfil requirements. Collaborate with globally located scientific personnel to ensure finalization of the documents, according to timelines and quality requirements.
- Compile, integrate and publish applicable documents with state-of-the-art word processing, electronic publishing and document management systems in collaboration with the responsible author(s).
- Work with external consultants (vendors) to coordinate outsourced QC activities related to the processed tasks. Responsible for verifying and consolidating the QC recommendations from the external consultants and partner with the respective document author(s) to reconcile findings and finalize the submission document(s).
- Resolve technical document or workflow issues as applicable on the documents being processed.
- Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of document management systems.
- Remain abreast of current processes, regulatory guidelines and legal requirements, as relevant.
- Collaborate with Submissions Management team on specialized projects, to support key submission deliverables.
- Collaborate to provide metrics, KQIs and KPIs.
Qualifications and Experience:
- Swiss working/residency permit and/or Swiss/EU-Citizenship required
- Undergraduate degree preferably in a scientific discipline or equivalent work experience
- English fluent (oral and written)
- Relevant work experience with electronic document management systems and document review.
- Basic understanding of clinical and nonclinical information contained in a submission dossier.
- Demonstrated ability to work successfully within a matrix environment and influence cross-functional teams.
- Flexible and detail oriented approach to documentation 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 Microsoft office programs (e.g. MS Word).
- 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.