Specialist, RIM Data Maintenance, Global Regulatory Operations
Position Title: Specialist, RIM Data Maintenance, Global Regulatory Operations
Location: Remote / Greenbag Road
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, Global Regulatory Operations 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 the RIM system for field definitions, data entry standards, system workflows, dashboards, searches, etc..
- Support the verification that information submitted to/coming from the Health Authorities (HA) is entered into the RIM system accurately and within established timelines by generating and analyzing complex system 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 review/analysis of system generated compliance reports. System corrections will be communicated to the data owners or corrected by Regulatory Operations, as appropriate.
- Submit master data requests for dictionary updates to the RIM system.
- Provide system support to generate complex 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.
The minimum qualifications for this role are:
· Must possess knowledge in data entry and data management. Must possess basic knowledge of Regulatory Affairs, with experience in Regulatory Information Management Systems and eCTD backbone structure a plus.
· Must possess ability to multi-task and manage multiple projects and deadlines. Ability to understand complex IT tools and software. Ability to read and interpret complex business and/or technical documents. Ability to work in a highly cross functional team environment. Must possess excellent attention to detail and propensity to learn. Must be proficient in Microsoft Word and Excel. Experience with Document Management Systems (e.g. D2) and/or Regulatory Information Management systems is preferred.
· Minimum of a Bachelor's degree (or equivalent) and 3 years of pharmaceutical industry experience. Experience in Regulatory Affairs or Regulatory Operations is strongly preferred. Other pharmaceutical experience (e.g. Research & Development, Quality Assurance/Compliance) will be considered
· Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
· Proficiency in speaking, comprehending, reading and writing English is required
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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.