Document Quality Specialist, Reg Affairs
Posted on Jun 26, 2021 by Michael Bailey Associates - Zurich
We have an exciting role for a Regulatory Operations consultant to support Submission team in assessment, quality control and publishing of scientific documents for high-quality submissions for Global Health Authorities.
1. Perform source data verification (SDV) and technical quality control (QC) of submission documents to ensure both content and format fulfil requirements.
2. Compile, integrate and publish applicable documents with state-of-the-art word pro-cessing, electronic publishing and document management systems in collaboration with the responsible author.
3. 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 to reconcile findings and finalize the submission documents
4. Resolve technical document or workflow issues as applicable on the documents being processed.
5. Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of document management systems.
Undergraduate degree preferably in a scientific discipline
* prior 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 (eg MS Word).
* Self-starter with a proven ability to prioritize work, mulita task, display customer centricity and manage time appropriately, in a fast paced/high volume environment.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.