Specialist, Rim Data Maintenance, Global Regulatory

2 weeks ago

Hatfield, United Kingdom Viatris Full time

1478 Generics [U.K.] Ltd.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the Specialist, RIM Data Maintenance role will make an impact:
Key responsibilities for this role include:

- Partner with the Regulatory teams on the creation/revision of records, objects, activities, etc. in the Regulatory Information Management (RIM) system for a large, global portfolio of pharmaceutical products.
- Collaborate with the Regulatory Affairs team to address queries related to RIM data.
- Support the verification that information submitted to/coming from the Health Authorities (HA) is entered into the RIM system accurately and within established timelines using various queries and reports.
- Participate in data cleansing operations to facilitate appropriate and timely access to data for key systems.
- Support the evaluation of data quality issues through the evaluation of system generated reports and trigger data corrections, as appropriate.
- Submit master data requests for dictionary updates for the RIM system.
- Provide support for data queries required by the various business units and escalate to the support team as needed.
- Propose improvements to the RIM system, processes, or procedures based on experience with use of the system.
- Contribute to the development and implementation of departmental Standard Operating Procedures (SOPs), user manuals, and data standards.
- Perform other duties as assigned.

The minimum qualifications for this role are:

- Bachelor’s degree or equivalent.
- Pharmaceutical industry experience in Regulatory Affairs or Regulatory Operations is strongly preferred. Other pharmaceutical related experience will be considered.
- Experience with Regulatory Information Management Systems and eCTD backbone structure is preferred.
- Ability to multi-task and manage multiple requests and deadlines.
- Ability to understand complex IT tools and software.
- Proficient with the use of Microsoft Office tools (Excel, PowerPoint, Word)
- Ability to work in a global and highly cross functional team environment.
- High attention to detail.
- Excellent written and verbal communication skills.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

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