Bristol-Myers Squibb Company

RIM Specialist

Location
Princeton, NJ, United States
Posted
Oct 16, 2019
Ref
R1517655
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The RIM Specialist will be a subject matter expert in the Regulatory Information Management (RIM) system with a focus on Labeling/ Company Core Data Sheet (CCDS) for all products. Workflows are used to distribute CCDS updates globally. The RIM labeling lead uses data quality reports to assess local market compliance to this critical process. Autonomous interaction with regulatory managers is necessary to troubleshoot and resolve issues. Metrics are reported to management for the each stage of the process from decision to revise labeling through to final distribution of new labeling in the local market.

Purpose/Objective

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. Enable data-centric submissions. Function as a super-user and RIM expert on all 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, CMC, country 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 regulatory processes that are enabled in the RIM system, including

Submissions and approvals for marketed products

Global dossier planning at the macro level and to the submission table of contents detail

Global labeling /core data sheet updates, distribution and tracking through country-level implementation of changes

Monitor CMC change control tracked to country-level submissions

Plan and track safety aggregate reporting and related submissions

Ensure information is logged for health authority (HA) interaction, correspondence and commitments

Accuracy of licensing and product specific details

Generation of portfolio and process metrics regarding BMS products. Create ad-hoc queries to support business decisions. Teach others to use this functionality. Assess reporting trends and utilize info to improve data quality or cycle time.

Communicate compliance issues to appropriate stakeholders, facilitate remediation, resolve complex issues and strive for continuous improvements. Review successes and failures and provide input on new approaches. Capture lessons learned.

Actively participate in cross-functional teams. Take steps to obtain and understand other functional area perspectives. Participate in Global submission plan (GSP) status meetings and/or safety reporting asset reviews. Capture minutes and ensure RIM updates reflect current data and status.

Utilize in-depth knowledge of data standards to work with data stewards. Recommend changes and updates based on interaction with end-users and in product teams. When agreements are reached with data owners and stewards ensure that revisions are implemented in data dictionaries, pick-lists, and naming conventions.

Function as a primary point of contact for the RIM system, provide support to R&D associates. Prioritize RIM issues and escalate technical problems to IT.

Facilitate data quality and ensure problems are tracked to closure. Analyze system usage against service agreements. Prepare metrics reports and present SLA issues to management and the governance BRIDG form with recommendations.

Maintain Frequently Asked Questions (FAQs). Author knowledge articles and approve materials drafted by junior associates. Hold periodic meetings to share tips and maintain regular communication with stakeholders and end-users.

Provide support for internal audits, HA inspections and corrective action plans.

Assist in review, approval, implementation and maintenance of work instructions and procedural documents. Review existing practices and propose updates based on changing regulations and trends.

Contribute regularly on special projects and initiatives that drive improvement.

Participate in RIM system updates and releases by interacting with IT to recommend system enhancements. Utilize in-depth knowledge of the integrations with R&D systems, the direction and frequency of data exchanged to ensure accuracy of RIM content. Monitor data exchange for potential issues. Collaborate on system validation necessary in a GxP environment. Review and execute test scripts. Train others on testing methods and ensure that documentation captured meets regulatory business needs

Working Practices

Manage personal assignments. Shares their expertise and knowledge through the teaching, coaching and mentoring of various colleagues. 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 BMS' products, development and business process and key therapeutic areas. Understands key Research and Development projects and initiatives.

Participates in personal development of self with supervisor by providing and asking for continuous and honest feedback.

Experience and Educational Requirements

A 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

Demonstrate 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, SPL, EVMPD, IDMP. Able to navigate content of Investigational and Marketing Application structure, or instruct others. Capable of maintaining internal standards and templates.

Firm, detailed knowledge and experience with computer systems in an R&D environment. Expertise in system validation, testing methods, GAMP guidelines and electronic records regulations (FDA Part 11 compliance). Posess the ability to evaluate user acceptance criteria.

First-hand experience in dealing with internal customers as well as outside contractors.

Expert with desktop applications, R&D systems and all integration points with RIM systems. Easily capable with new software and procedures. Follows technology trends.

Excellent command of English language, both written and oral. Good presentation skills.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.