Document Quality Specialist

Job Purpose

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.

Major Accountabilities

• Perform source data verification and technical quality control of submission documents (simple to medium complexity) to ensure both content and format fulfil requirements.
• Collaborate with globally located 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).

Ideal Background

• Education: Undergraduate degree preferably in a scientific discipline or equivalent work experience
• Languages: English fluent (oral and written)
• 3-5 years of relevant work experience with electronic document management systems and document review
• Basic understanding of clinical and nonclinical information contained in a submission dossier