Job Description

Regulatory Information Management (RIM) Specialist
Job Number: 19-10299
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Regulatory Information Management (RIM) Specialist 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!
 
Responsibilities:
  • Ensure RIM Inbox requests for correspondence, commitments and registrations are entered in the Veeva system to meet data quality standards in the timelines established
  • Create, modify and run reports, as needed
  • Perform any ad hoc data entry requests in Veeva as they arise
  • Partner with the Data Stewardship team and users worldwide to insure that data quality standards in Veeva are met and support the resolution of any issues that are identified, striving for continuous improvements
  • Drive data quality and user engagement by advising Customer Engagement Liaison’s (CEL’s) and functional area colleagues on their use of the system
  • Communicate effectively with internal and external stakeholders
  • Provide training and support to Veeva users as needed
  • Assist in the creation and maintenance of work instructions, Quick Reference Guides (QRG’s) and other procedural documents on key Veeva processes
  • Support and maintain SharePoint sites. Insure that the appropriate usernames are mapped to security groups in Veeva in a timely manner
  • Support the resolution of any issues that are identified
  • Actively participate and lead cross-functional teams in the matrix
  • Take steps to obtain and understand other functional area perspectives
  • Provide support for internal audits, HA inspections and corrective action plans
  • Shares their expertise and knowledge through the teaching, coaching and mentoring of various colleagues
  • Manage personal assignments
  • Embraces a healthy work environment with sensitivity to the balance between personal and professional life
  • Demonstrates flexibility to work simultaneously on multiple projects and meet ambitious timelines
  • Establishes and executes plans for managing workload within their assigned project(s) through efficient resource utilization and within designated timeframes
  • Effectively adjusts plans to deal with changes and obstacles
  • Collaborate across cultural and organization boundaries to achieve business results
  • Refined attention to detail and critical thinking capabilities
  • Follow specific and stringent standards and processes
  • Thinks in a clear, decisive manner, remains calm under adverse conditions
  • Develop knowledge of Client' products, development and business process and key therapeutic areas
  • Participates in personal development of self with supervisor by providing and asking for continuous and honest feedback
 
Required Experience:
  • BS in a relevant scientific or technical field and 4-8 years of pharmaceutical industry experience
  • Experienced with the drug development process
  • Solid regulatory knowledge and previous experience in the Regulatory Information Management area
  • Demonstrated experience and understanding of the procedures and decision-making process of the Health Authorities, as it relates to RIM
  • Clear knowledge and experience with electronic submission standards and requirements such as eCTD.
  • Firm, detailed knowledge and experience with computer systems in an R&D environment. Expert with desktop applications (MS Excel), R&D systems and all integration points with RIM systems
 
Required Skills:
  • Follows technology trends
  • Excellent command of English language, both written and oral
  • Good presentation skills
 
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:
Chris Sta Juana
christian.sta.juana@eclaro.com
2128047469
Chris Sta Juana | 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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