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18 Feb 2021

Temporary Regulatory Information Management (RIM) Consultant(21-04298)

Axelon Services Corporation – Posted by iris.chen@axelon.com Lawrence Township, New Jersey, United States

Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description:
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 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 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

Experience Requirements:
• Minimum of 3 years work in Regulatory Affairs
or
• 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 QRG’s

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 76 days.

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