- Expiry Date: 06 February 2022
RIM Consultant - Correspondence, HAQDivision
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 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 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 CLIENT compliance and processes, especially where systems are impacted
Position Summary / Objective
The RIM Consultant will be accountable for entering and managing regulatory information in a Veeva RIM System. This individual will upload Correspondence and create/track Health Authority queries through to closure. This individual will have cross-functional knowledge of Commitments from a regulatory operations perspective.
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.
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.
Function as a process expert for correspondence and health authority queries in the RIM system.
Execute operational aspects of assigned regulatory processes to ensure compliance.
Partner 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 Liaison’s (CEL’s) 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 (QRG’s) and other procedural documents, as needed.
Supports and maintains SharePoint sites, as needed.
Minimum of a BS/BA in a relevant scientific or technical field
Minimum of 3 years work in Regulatory Affairs or
Minimum of 5 years of pharmaceutical industry experience
Key Competency Requirements
Strong understanding of Health Authority Correspondence and HA Query tracking in a pharmaceutical environment.
Strong understanding and practical experience in regulatory operations.
Demonstrates excellent critical thinking skills in daily work, in alignment with group/company objectives.
Demonstrates an understanding of the procedures and decision-making process of relevant Health Authorities.
Regulatory Data Management experience and an understanding of electronic records management rules, including ALCOA+.
Microsoft office - intermediate knowledge of Excel, PowerPoint and Word
Strong communication and change management skills
Excellent command of the English language, including the ability to communicate in both written and oral forms.
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