Regulatory Information Management Systems ( RIM) Consultant
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our Client is a leading Pharmaceutical company is hiring a Sr. RIM Consultant ( Regulatory Information Management ) on a contracting Basis.
Location: Lawrenceville, NJ
Duration: 6 Months
Sr. RIM Consultant - Correspondence/HAQ/Commitments/Registrations
Division: Research and Development / Global Regulatory, Safety and Biometrics /
Global Submissions and Regulatory Policy - Global Regulatory Business Capabilities
Functional Area Description Global Regulatory Business Capabilities
In collaboration with the business, sets the strategic business direction for the development and maintenance of systems used in GRS, including responding to any needs for regulatory data from other parts of the Major Pharmaceutical Company enterprise
Oversees the strategic direction of the data quality programs necessary to achieve and maintain high data quality in GRS systems
Oversees and leads the development, data readiness, process development and country onboarding of Major Pharmaceutical Company medical product data management program
Establishes and maintains a set of regulatory standards for data and processes in scope
Responsible for the leadership and oversight of operational activities for implemented systems and processes
Evaluates internal and external requirements and guidance with impact to Major Pharmaceutical Company compliance and processes, especially where systems are impacted
Position Summary / Objective The RIM Consultant is accountable for entering and managing regulatory information in the authoritative system. Specifically, this individual will fulfill RIM requests for the upload of correspondence, the data entry and tracking of health authority queries to closure, as well as the tracking of commitments and registrations in the Veeva system to meet data quality standards in the timelines established.
The RIM Consultant will interact regularly with global regulatory managers, country managers and other regulatory associates to ensure that data in the RIM tool is available in a complete, accurate, and timely manner.
As a subject matter expert in Veeva reporting, be able to create, modify and run reports, as needed. Perform ad hoc data entry requests in Veeva as they arise.
The RIM Consultant will drive efficiency by advising functional area colleagues on their use of the system and recommend process improvements from a functional area perspective.
Position Responsibilities Functions as a process expert for correspondence, health authority queries, commitments and registrations in the RIM system.
Executes operational aspects of assigned regulatory processes to ensure compliance.
Partners with the Data Stewardship team to insure that data quality standards in Veeva are met and supports the resolution of any issues that are identified, striving for continuous improvement. Drives data quality and user engagement by advising Customer Engagement Liaisons (CELs) and functional area colleagues on their use of the system.
Provides training and support to Veeva users as needed.
Assists in the creation and maintenance of work instructions, Quick Reference Guides (QRGs) and other procedural documents on key Veeva processes.
Supports and maintains SharePoint sites, as needed.
Provides support for internal audits, HA inspections and corrective action plans, as needed.
Degree Requirements: Minimum of a BS/BA in a relevant scientific or technical field
Minimum of 3 years work in Regulatory Affairs
Minimum of 5 years of pharmaceutical industry experience
Key Competency Requirements
Experienced in managing correspondence, tracking HA queries, commitments and registrations in a pharmaceutical environment.
Demonstrates excellent critical thinking skills and attention to detail in daily work, in alignment with group/company objectives.
Demonstrates an understanding of the procedures and decision-making process of relevant Health Authorities.
Strong understanding and practical experience in regulatory operations
Demonstrates flexibility to work simultaneously on multiple projects and meet ambitious timelines. Effectively adjusts plans to deal with changes and obstacles.
Microsoft office - intermediate knowledge of Excel, PowerPoint and MS Word
Intermediate knowledge of SharePoint
Report and dashboard creation experience, preferred (Veeva Vault)
Strong communication and change management skills
Excellent command of the English language, including the ability to communicate in both written and oral forms.
Strong presentation skills, including presentation to senior leaders. Able to summarize key messages appropriately for different audiences
Experience instructing/ training end-users
Experienced in the development of work instructions and QRGs
Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested.