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Regulatory & Medical AffairsConsultant

  • Location: Lawrenceville
  • Job Type:Contract

Posted 7 months ago

  • Expiry Date: 06 February 2022

​​​​​​Job Description:

  • 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.

Position Responsibilities

  • 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.

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

  • 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.

About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.