RIM Database Associate

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose/Objective of the job


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 ensure that the registration status is up-to-date and accurate in all countries that market BMS products.
Resolve contacts with end-users within the expected time frames or escalate appropriately.
Proactively seize opportunities to improve user effectiveness. Communicate potential service level issues to management. Prepare reports for BRIDG governance review. Communicate effectively with internal customers.
Create and monitor work flows that progress regulatory objectives and activities. Expand knowledge and skills to develop expertise across all areas of system functionality.
Function as a super user with at least 3-6 of the following regulatory processes enabled in the RIM system:
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, incuding the tracking of CMC/ product details
Plan and track US safety aggregate reporting and related submissions
Ensure information is logged for health authority (HA) interaction, correspondence and commitments
Manage the creation and QC of all HA queries and interactions with SMEs
Track submitted US investigator documents in eTMF
Support other regulatory processes when needed including the Global Submission Plan, Risk Management Plan and Submission Content Plan
Generate portfolio and process metrics regarding BMS products.

Utilize RIM knowledge to identify problems and lead problem solving efforts. Engage with stakeholders while resolving issues, ensure they understand data related procedures to achieve data accuracy.
Maintain full proficiency of data standards, dictionaries, and naming conventions used with regulatory data.
Verify and ensure correctness of submission data in the RIM system related to investigational trials and commercial product details. Utilize knowledge of the integration with R&D systems, the direction and frequency of data exchange as it pertains to RIM attributes.
Demonstrate an understanding of dossier requirements for major and compliance submissions and be able to articulate this to peers.
Monitor data quality by running RIM reports on applications, submissions and registrations. Provide information or metrics when requested. Utilize data views and evaluate query or report results to check process compliance and completeness of the data. Remediate issues. As needed, guide others on the use of reports and queries.
Possess knowledge of regulatory practices, business rules and departmental procedures.
Guide and motivate others on basic technical, regulatory department documents and/or submissions. Train other staff and RIM end-users.
Participate in improvement initiatives and special projects lead by others.
Participate in RIM system testing and upgrades with expertise in validation practices that support a GxP environment. Run test scripts and 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.


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

Experience and Educational Requirements


Bachelor's degree in scientific or technical subject with 2-4 years of regulatory & 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.


Additional Information:


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.
Ability to operate within an organization composed of technically and culturally diverse people.
Experienced dealing with internal customers as well as outside contractors.
Demonstrated ability to follow specific and stringent standards and processes.
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.
Enhance coaching, leadership skills. Proactively mentors colleagues.


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Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1526949_EN

Updated: 2020-06-29 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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