Fully Remote Contract - Associate Director, Regulatory Systems
Vacancy expired!
Title: Contract - Associate Director, Regulatory Systems
Location: Fully Remote
Duration: 6+ Month contract
About the Company: A global Pharmaceutical Company
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
About the Position: 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 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.
Your Main Responsibilities:
In partnership with IT and QA, and the head of Regulatory Operations, manages and develops system design and validation documentation for R&D 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)
Requirements
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
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
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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