Job Description

Regulatory Information Management (RIM) Consultant
JobDiva # 21-00850

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:
  • Research and Development / Global Regulatory, Safety and Biometrics / Global Submissions and Regulatory Policy - Global Regulatory Business Capabilities
  • 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.

Responsibilities:
  • 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 Client 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 Client’ 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
  • 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.

Qualifications:
  • 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
  • Experienced in managing correspondence, tracking HA queries, commitments and registrations in a pharmaceutical environment.
  • Experience instructing/ training end-users
  • Experienced in the development of work instructions and QRG’s

Preferred Skills:
  • 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

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:
 
Jane Bautista
froilyn.bautista@eclaro.com
2012858622
Jane Bautista | 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

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