Bristol-Myers Squibb Company

RIM Specialist

Location
Princeton, NJ, US
Posted
Jan 18, 2019
Ref
R1512301
Required Education
Bachelors Degree
Position Type
Full time
The RIM Specialist will manage regulatory information (RIM) in the authoritative system for submissions, approvals and associated product data. Ensure data is available in a complete, accurate, and timely manor. Monitor data quality in BMS systems from planning of regulatory activities through Health authority interaction and to country/ regional implementation. Function as a super-user and RIM expert on all system-supported processes and data requirements. Drive efficiency by advising functional area colleagues on their use of the system

• Fluent with all RIM/ RA processes, developing stronger expertise in multiple.
• Works proactively in cross functional teams. Able to communicate compliance concerns and facilitate remediation.
• Recommend process simplification
• Capable of training and presenting to groups.
• Knows HA decision making processes related to RIM
• 4-8 yr RIM/ Pharma, drug development knowledge
• BS level degree - science or technology
• Clear knowledge of Regulatory standards. eCTD, SPL, EVMPD, IDMP. Able to navigate content of Investigational and Marketing Application structure, or instruct others
• Expert with desktop applications, R&D systems and all integration points with RIM systems. Easily capable with new software and procedures. Follows technology trends.
• Firm knowledge of system validation. Posses the ability to evaluate user acceptance criteria.

This group is grounded in Regulatory expertise with a firm understanding of Informatics.

Purpose/Objective of the job

Maintain regulatory information (RIM) in the authoritative system for submissions, approvals and associated product data. Ensure data is available in a complete, accurate, and timely manor. Monitor data quality in BMS systems from planning of regulatory activities through Health authority interaction and to country/ regional implementation. Enable data-centric submissions. Function as a RIM expert on the system-supported processes and data requirements. Drive efficiency by advising functional area collegues on their use of the system.

Key Responsibilities and Major Duties
  • Interact with regulatory liaisons, global regulatory managers, and dossier leads to create initial applications, plan submissions and track products throughout their lifecycle. Ensure that the registration status is up-to-date and accurate in all countries that market BMS products.
  • Create and monitor work flows that progress regulatory objectives and activities.
  • Support all RA processes that are enabled in the RIM system, including
    • Submissions and approvals for marketed products
    • Global dossier planning at the macro level and to TOC detail
    • Core data sheet updates, global distribution, through country-level implementation of labeling changes
    • CMC change control tracked to country-level submissions
    • Safety aggregate reporting
    • Health authority (HA) interaction, correspondence and commitments
    • Accuracy of registrations and product specific details
    • Generation of portfolio and process metrics regarding BMS products. Create ad-hoc queries to support business decisions.
  • Communicate compliance issues to appropriate stakeholders, facilitate remediation and strive for continuous improvements.
  • Function as a primary point of contact for the RIM system, provide support to R&D associates, and maintain Frequently Asked Questions (FAQs). Prioritize issues and escalate technical problems to IT. Hold periodic meetings to share tips and maintain regular communication with stakeholders and end-users.
  • Provide support for internal audits and HA inspections
  • Assist in review, approval, implementation and maintenance of work instructions and procedural documents
  • Work with data stewards to implement changes or updates to data standards, pick-lists, and naming conventions.
  • Participate in user acceptance testing for RIM system updates and releases. Interact with IT to recommend system enhancements.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship)

NA

Experience and Educational Requirements
  • A BS in a relevant scientific or technical field.
  • Two to four years of pharmaceutical industry experience
  • Experience with the drug development process and solid regulatory knowledge and experience in the Regulatory Information Management area
    • Basic knowledge and understanding of the procedures and decision-making process of the Health Authorities, as it relates to RIM .
    • Knowledge and experience with electronic submission standards and requirements such as eCTD, SPL, EVMPD, IDMP. Clear understanding of Investigational and Marketing Application structure, content and navigation
  • Attention to detail. Demonstrated ability to work in an organized and consistent manner even under pressure.
  • Demonstrated ability to operate effectively within an organization composed of technically and culturally diverse people.
  • First-hand experience in dealing with internal customers as well as outside contractors.
  • Thorough knowledge of desktop applications, comfortable learning new software and procedures.
  • Good command of English language, both written and oral.