Job Description :
Position Details:
Job Title: Regulatory Information Management (RIM) Consultant
Location: Lawrenceville, NJ, 08648
Duration: 12 Months
Job Description
Experience and Educational 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.
o Experience with the procedures and decision-making process of government Health Authorities and it relates to RIM.
o 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)
Purpose/Objective of the job
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
Key Responsibilities and Major Duties
Interact with regulatory liaisons, global regulatory managers, and dossier leads to ensure that the registration status is up-to-date and accurate in all countries that market products.
Resolve contacts with end-users within the expected time frames or escalate appropriately.
Proactively seize opportunities to improve user effectiveness. Communicate potential service level issues to management. Communicate effectively with internal customers.
Create and monitor work flows that progress regulatory objectives and activities. Expand knowledge and skills to develop expertise across all areas of system functionality.
Function as a super user with at least 3-6 of the following regulatory processes enabled in the RIM system:
o Submissions and approvals for marketed and investigational products
o Accuracy of licensing and product specific details
o Global labeling /core data sheet updates, distribution and tracking through country-level implementation of changes
o CMC change control distribution and tracking to country-level submissions, incuding the tracking of CMC/ product details
o Ensure information is logged for health authority (HA) interaction, correspondence and commitments
o Manage the creation and QC of all HA queries and interactions with SMEs
o Track submitted US investigator documents in eTMF
o Support other regulatory processes when needed including the Global Submission Plan, Risk Management Plan and Submission Content Plan
o Generate portfolio and process metrics regarding products.
Utilize RIM knowledge to identify problems and lead problem solving efforts. Engage with stakeholders while resolving issues, ensure they understand data related procedures to achieve data accuracy.
Maintain full proficiency of data standards, dictionaries, and naming conventions used with regulatory data.
Verify and ensure correctness of submission data in the RIM system related to investigational trials and commercial product details. Utilize knowledge of the integration with R&D systems, the direction and frequency of data exchange as it pertains to RIM attributes.
Demonstrate an understanding of dossier requirements for major and compliance submissions and be able to articulate this to peers.
Monitor data quality by running RIM reports on applications, submissions and registrations. Provide information or metrics when requested. Utilize data views and evaluate query or report results to check process compliance and completeness of the data. Remediate issues. As needed, guide others on the use of reports and queries.
Possess knowledge of regulatory practices, business rules and departmental procedures.
Guide and motivate others on basic technical, regulatory department documents and/or submissions. Train other staff and RIM end-users.
Participate in improvement initiatives and special projects lead by others.
Participate in RIM system testing and upgrades with expertise in validation practices that support a GxP environment. Run test scripts and 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.