Document Quality Manager

vor 2 Wochen

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**_The Life Science Career Network_**

**Document Quality Specialist (4621 - ETH)**

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are currently looking for a** Document Quality Specialist **in **Basel, Switzerland **on a **12 months contract.**

**Main Responsibilities**:

- Performance of source data validation (SDV) and technical quality control of submission documents to ensure content and format fulfil requirements while collaborating with scientific personnel to ensure finalization of the documents, according to timelines and quality requirements
- Compilation, integration and publication of documents with state-of-the-art word processing, electronic publishing and document management systems in collaboration with the responsible authors
- Collaborating with external consultants to coordinate outsourced QC activities related to the processed tasks. Responsible for verifying and consolidating the QC recommendations from the external consultants and partners with the respective document authors to reconcile findings and finalize the submission documents
- Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of the document management systems
- Stay abreast of current processes, regulatory guidelines and legal requirements, as relevant.

**Qualifications and Experience**:

- 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.
- Relevant working/residency permit or Swiss/EU-Citizenship required

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