We have a current opportunity for an Associate Director, Regulatory Systems on a 6-month contract basis. The position will be based in San Diego. For further information about this position please apply.
The Temporary Associate Director, Regulatory Systems will support the management, maintenance, and implementation of new systems, tools, and processes for document management, regulatory publishing, and regulatory information management. Under the supervision of the head of Regulatory Operations, this position will work closely with Information Technology and Quality Assurance to develop and implement configuration changes and updates to Veeva Vault, RIM, and IQVIA RIM Smart systems. Additionally, this role will work closely with operational functions within R&D (e.g., Medical Writing, Translational Sciences Operations, Clinical Operations, etc.) to develop and implement updated/new processes to refine and expand R&D document management and regulatory information management capabilities.
Requirements:
- In partnership with IT and QA, and the head of Regulatory Operations, manages and develops system design and validation documentation for R&D's document management system (Veeva Vault RIM) and publishing system (IQVIA RIM Smart) including but not limited to: user requirements specifications, performance qualification/UAT scripts, and traceability matrices
Works with colleagues in Regulatory Affairs and other functions to define user requirements, new/updated processes in support of R&D document management and regulatory information management.
* Assists in evaluation of potential new regulatory systems and publishing/document authoring tools
* Leads Regulatory Operations-driven projects including implementation of MS Word CTD authoring templates and macro functionality
* Develops new and updated end-user training for regulatory systems
* On an as-needed basis, works with Regulatory Operations and other users of regulatory systems to identify and troubleshoot issues (engaging IT where necessary)
Education:
Bachelor's degree in a related discipline (e.g., life sciences, information technology, business) with a minimum of 5-7 years of experience in pharmaceutical/biotechnology/medical device environment (regulatory affairs or information technology or related function) preferred
Must possess:
Strong knowledge of pharmaceutical regulatory affairs processes related to submission preparation/publishing/archival and regulatory information management
* Experience implementing and supporting validated regulatory/R&D systems including document management, regulatory publishing, and regulatory information management systems
* Demonstrated knowledge of the overall computerized systems validation process
* Strong project management and verbal/written communication skills
* Ability to work cross-functionally to develop new processes and identify gaps/opportunities for improvement in existing processes
* Ability to problem solve and troubleshoot user-reported and potential technical issues related to document management, regulatory publishing, and regulatory information management systems (in collaboration with IT as needed)
* Previous experience developing end-user training for regulatory systems preferred
* Experience implementing CTD authoring tools/templates preferred