Job Description

Regulatory Information Management (RIM) Consultant
JobDiva # 20-08892

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Regulatory Information Management (RIM) Consultant for our client in Lawrenceville, NJ.  

Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:
  • The RIM Specialist will be a subject matter expert in the Regulatory Information Management (RIM) system with focus on actlivties like planing, tracking and monitoring 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 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).

Responsibilities:
  • 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 Client 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 Client 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.
  • 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.

Preferred Skills:
  • Independently manages daily responsibilities and complex project assignments. 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.
  • Good command of English language, both written and oral.

Qualifications:
  • Bachelors 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.

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If interested, you may contact:
 
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | LinkedIn


Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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