Title: RIM Database Associate Location: Lawrenceville, NJ Schedule: 8am to 5pm Mon – Fri. Start date: ASAP Responsibilities: The RIM Database Associate will be a subject matter expert in the Regulatory Information Management (RIM) system with a focus on Chemistry Manufacturing Change Control (CMC). They will utilize Veeva Vault RIM software to manage global distribution of CMC Change Control events for both commercial and investigational products, and manage drug product and drug substance details for submissions, in all markets. Accuracy of CMC data is essential since it is transitioned for related processes via system integration. Autonomous interaction with local markets is necessary to troubleshoot and resolve issues. Prompt attention to business critical activities ensures release of clinical supplies to market and appropriate documentation of regulatory approvals that impact supply chain. Plan, track and monitor activities related to commercial and investigational products, applications/ submissions and registrations. Function as a super user across 3-6 areas (such as labeling and commitments, CMC change management). Interact with regulatory associates globally. Maintain departmental procedural documents. Solve problems, support users, address questions and capture data related to system inquires. Track and monitor regulatory activities related to commercial and investigational products, applications/ submissions, and correspondence. Update FAQs and draft knowledge articles for the system operations site. Support system upgrades by executing test scripts and being directly involved in validation. Maintain data accuracy in the authoritative RIM system(s). Interact with regulatory liaisons, global regulatory managers, and dossier leads to maintain accurate registrations in all countries that market company products. Create and monitor workflows to progress regulatory activities. Expand knowledge and skills to develop expertise across all areas of RIM system functionality. Submissions and approvals for marketed and investigational products. Accuracy of licensing and product specific details Global labeling /core data sheet updates, distribution and tracking through country-level implementation of changes CMC change control distribution and tracking to country-level submissions, including the tracking of CMC/ product details Process data and QC information for health authority (HA) interaction, correspondence and commitments. Resolve data issues with SMEs to ensure completeness and accuracy Track submitted US investigator documents in eTMF Plan and track US safety aggregate reporting and related submissions Support ad hoc requests and resources when needed for the Global Submission Plan, Risk Management Plan and Submission Content Plan Generate reports for portfolio and process metrics regarding company products. Communicate effectively with internal customers, proactively seize opportunities to improve user effectiveness. Raise potential service level issues to management. Prepare reports for BRIDG data governance review. Maintain full proficiency of data standards, dictionaries, and naming conventions used with regulatory data. Understand the relationship to company business rules and departmental procedures. Demonstrate an understanding of dossier requirements for major and compliance submissions. Be able to articulate this to peers. Utilize knowledge of the integration with R&D systems, the direction and frequency of data exchange as it pertains to RIM attributes. Monitor data quality and support remediation to ensure accuracy of the RIM content. Leverage data views and evaluate results to confirm process compliance. Metrics are provided to management regularly. Coach and guide others on the use of reports and queries. Train other staff and RIM end-users. Guide and motivate others on basic technical, regulatory department documents and/or submissions. Participate in improvement initiatives and special projects lead by others. Test RIM system upgrades with validation practices supporting a GxP environment. Document outcomes, highlight script issues or technical errors. Train others on testing methods, as needed. Recommend FAQ updates and topics for user groups. Draft knowledge articles for the RIM operations site.
Requirements: Bachelor’s degree in scientific or technical subject with 2-4 years of industry experience. Solid understanding of drug development processes and regulatory knowledge. Experience with the procedures and decision-making process of government Health Authorities and it relates to RIM. Firm knowledge and experience with eCTD, SPL, submission standards and requirements. Ability to navigate Investigational and Marketing Application submission structure and content. Knowledge of computer systems validation (GAMP guidelines) and electronic records (FDA Part 11 compliance) Expertise in essential desktop applications (MS Office suite) Practical knowledge of R&D systems and able to learn new software easily. Good command of English language, both written and oral.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.