Job Description

Regulatory Information Management Database Associate
Job Number: 20-00141
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Regulatory Information Management  Database Associate  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:
  • Will be a subject matter expert in the Regulatory Information Management (RIM) system with a focus on Chemistry Manufacturing Change Control (CMC).
  • Will utilize Veeva Vault RIM software to manage global distribution of CMC Change Control events for both commercial and investigational products, and manage drug product and drug substance details for submissions, in all markets.
  • Accuracy of CMC data is essential since it is transitioned for related processes via system integration.
  • Autonomous interaction with local markets is necessary to troubleshoot and resolve issues.
  • Prompt attention to business critical activities ensures release of clinical supplies to market and appropriate documentation of regulatory approvals that impact supply chain.
  • Plan, track and monitor activities related to commercial and investigational products, applications/ submissions and registrations.
  • Function as a super user across 3-6 areas (such as labeling and commitments, CMC change management).
  • Interact with regulatory associates globally.
  • Maintain departmental procedural documents.
  • Solve problems, support users, address questions and capture data related to system inquires.
  • Track and monitor regulatory activities related to commercial and investigational products, applications/ submissions, and correspondence.
  • Update FAQs and draft knowledge articles for the system operations site.
  • Support system upgrades by executing test scripts and being directly involved in validation.
  • Maintain data accuracy in the authoritative RIM system(s).
 
Responsibilities:
  • Major Duties:
    • Interact with regulatory liaisons, global regulatory managers, and dossier leads to maintain accurate registrations in all countries that market Client products.
    • Create and monitor work flows to progress regulatory activities.
    • Expand knowledge and skills to develop expertise across all areas of RIM system functionality.
    • These processes include:
    • Submissions and approvals for marketed and investigational products. Accuracy of licensing and product specific details
    • Global labeling /core data sheet updates, distribution and tracking through country-level implementation of changes
    • CMC change control distribution and tracking to country-level submissions, including the tracking of CMC/ product details
    • Process data and QC information for health authority (HA) interaction, correspondence and commitments. Resolve data issues with SMEs to ensure completeness and accuracy
    • Track submitted US investigator documents in eTMF
    • Plan and track US safety aggregate reporting and related submissions
    • Support ad hoc requests and resources when needed for the Global Submission Plan, Risk Management Plan and Submission Content Plan
    • Generate reports for portfolio and process metrics regarding Client products.
    • Communicate effectively with internal customers, proactively seize opportunities to improve user effectiveness.
    • Raise potential service level issues to management. Prepare reports for BRIDG data governance review.
    • Maintain full proficiency of data standards, dictionaries, and naming conventions used with regulatory data.
    • Understand the relationship to Client business rules and departmental procedures.
    • Demonstrate an understanding of dossier requirements for major and compliance submissions.
    • Be able to articulate this to peers.
    • Utilize knowledge of the integration with R&D systems, the direction and frequency of data exchange as it pertains to RIM attributes.
    • Monitor data quality and support remediation to ensure accuracy of the RIM content.
    • Leverage data views and evaluate results to confirm process compliance. Metrics are provided to management regularly.
    • Coach and guide others on the use of reports and queries.
    • Train other staff and RIM end-users.
    • Guide and motivate others on basic technical, regulatory department documents and/or submissions.
    • Participate in improvement initiatives and special projects lead by others.
    • Test RIM system upgrades with validation practices supporting a GxP environment. Document outcomes, highlight script issues or technical errors.
    • Train others on testing methods, as needed.
    • Recommend FAQ updates and topics for user groups.
    • Draft knowledge articles for the RIM operations site.
  • Working Practices:
    • Independently manages daily responsibilities and complex project assignments. Exercise organizational skills and close attention to detail.
    • Adapt to a higher work load and multiple projects with clear focus on quality.
    • Seek opportunity to work on cross functional project teams and interact with clients.
    • Align expectations on timelines with clear communication.
    • Handle complex assignments.
    • Adapt to a higher work load and multiple projects with clear focus on quality.
    • Demonstrated ability to follow specific and stringent standards and processes, understanding company goals and objectives.
    • Enhance coaching, leadership skills.
    • Proactively mentors colleagues.
    • Experienced dealing with internal customers as well as outside contractors.
    • Operate within an organization composed of technically and culturally diverse people.
    • Ability to operate within an organization composed of technically and culturally diverse people.
    • Has an understanding of company goals and objectives and supports a multifunctional team.
    • Mature time and project management skills, resolve issues and align expectations on timelines with clear communication.
    • Seek opportunity to work on project teams and interact with clients.
 
Required Qualifications:
  • Bachelor’s degree in scientific or technical subject with 2 - 4 years of industry experience.
  • Solid understanding of drug development processes and regulatory knowledge.
  • Experience with the procedures and decision-making process of government Health Authorities and it relates to RIM.
  • Firm knowledge and experience with eCTD, SPL, submission standards and requirements.
  • Ability to navigate Investigational and Marketing Application submission structure and content.
  • Knowledge of computer systems validation (GAMP guidelines) and electronic records (FDA Part 11 compliance)
  • Expertise in essential desktop applications (MS Office suite)
  • Practical knowledge of R&D systems and able to learn new software easily.
  • Good command of English language, both written and oral.
 
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:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | 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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