RIM Database Associate

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 Database Associate will be a subject matter expert in the Regulatory Information Management (RIM) system with a focus on Heath Authority Queries (HAQ). They will utilize Veeva Vault RIM software to manage timely data entry and linking of queries for investigational or marketed products. Workflows are used for task management and data verification by subject matter experts (SMEs) across the BMS Development organization. The RIM staff is responsible for data quality check on all HAQs and to monitor process compliance. They provide reports, metrics and maintain dashboards as needed.
To ensure business continuity this new associate will also function as a back-up for other RIM Services processes.

Purpose/Objective

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).

Key Responsibilities and Major Duties

Interact with regulatory liaisons, global regulatory managers, and dossier leads to maintain accurate registrations in all countries that market BMS 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, querriesand 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 BMS 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 BMS 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

Manage daily responsibilities independently, as a detail oriented individual with strong time management and organizational skills.

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.

Experience and Educational Requirements

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.

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.