Document Control Manager
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POST DATE 8/10/2016
END DATE 12/19/2016
JOB DESCRIPTIONThe position is responsible for execution of secure cloud based document management and control processes. Research Clinical/Regulatory secure cloud-based document management systems, choose appropriate system, drive the implementation, and assist with adoption through training and the general administrator function for accuracy and completeness.
* Experience with data migration to secure environment.
* Selection of cloud based document management system, implementation and training.
* Experience with document organization, and data migration of Regulatory and CMC documents.
* Perform overall technical and developmental editing reviews of clinical, regulatory, and development document types; protocols, amendments, clinical study reports, Investigator's Brochures, Investigational Medicinal Product Dossiers, INDs and IND amendments, briefing books, patient narratives, abstracts, and manuscripts.
* Perform data verification and consistency.
* Perform full editorial reviews.
* Work with Medical Writing department and other authors to resolve issues and answer questions about style, guidance, regulations, etc.
* Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) and department guidelines.
* Review documents being logged within the quality document system to verify completeness, legibility, formatting, etc.
* Assist with document control activities, as assigned, including electronic and paper logging, filing, and archiving of qualitysystem documents; document change management; training documentation management, etc.
* Assist with document logistics during regulatory inspections (e.g., retrieval, logging, review, notifications).
* BS/BA or higher in a relevant field.
* 4+ years of document QC experience in an FDA (or equivalent) regulated industry.
* Experience in document management system selection and implementation.
* Experience in quality control and/or quality assurance review of regulatory submissions / aggregate reports within the pharmaceutical/regulated industry is critical, including review of documents in an eCTD system.
* Demonstrated analytical skills and extremely high attention to detail.
* Experience with cloud based electronic document management systems (e.g., Veeva Vault, Documentum, NextDocs).