RIM Specialist

Job Post Index 2378F6-Sy##
Location Lawrenceville, NJ
Description: Description
  • The RIM Specialist will be a subject matter expert in the Regulatory Information Management (RIM) system with focus on activities like planing , tracking and monitoring activities related to commercial and investigational products, applications/ submissions and registrations.
  • Interact with regulatory associates globally with main focus on Intercontinetal region .
  • Maintain departmental procedural documents.
  • Solve problems, support users, address questions and capture data related to system inquires.
  • Maintain data accuracy in the authoritative RIM system(s).
  • Interact with regulatory liaisons, global regulatory managers, and International Strategy leads ( ISLs) 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:
    • 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
    • Ensure information is logged for health authority (HA) interaction, correspondence and commitments
    • Manage the creation and QC of all HA queries and interactions with SMEs
    • Support other regulatory processes when needed including the Global Submission Plan, Risk Management Plan and Submission Content Plan
    • 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.
  • 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.
  • Guide/train others on the use of reports and queries.
  • 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.
  • Independently manages daily responsibilities and complex project assignments.
Skills: 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.
  • Demonstrate an understanding of dossier requirements for major and compliance submissions and be able to articulate this to peers.
  • 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.
  • Possess knowledge of regulatory practices, business rules and departmental procedures.
  • Exercise organizational skills and close attention to detail.
  • Adapt to a higher work load and multiple projects with clear focus on quality.
  • Ability to operate within an organization composed of technically and culturally diverse people and experience in Intercontinental region ( MOW ) is highly desirable .
  • Experienced dealing with internal customers as well as outside contractors.
  • Demonstrated ability to follow specific and stringent standards and processes.
  • Has an understanding of company goals and objectives and supports a multifunctional team.
  • Mature time and project management skills, resolve issues and align expectations on timelines with clear communication.
  • Seek opportunity to work on project teams and interact with clients.
  • Enhance coaching, leadership skills.
  • Proactively mentors colleagues.

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