Labeling Compliance Coordinator

3 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.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Labeling Compliance Coordinator role will make an impact:
- Responsible for oversight of compliance with global labelling processes and supporting associated regional labelling for inspection readiness.- CoE Subject matter expert across all Regulatory and Document management systems.- Tracking of labelling updates, deviations, and management of change control records.- Data entry, corrections, and manipulation across pertaining to Labelling documents and data.- Develop metrics and reporting that support Global Labelling Compliance monitoring.- Creating and managing a dashboard to make visible that labelling deliverables have appropriate KPI’s which are tracked reviewed and communicated according to plan.- Assist with producing and maintaining training material, SOPs and other written standards outlining labelling procedures and best practices to guarantee international compliance.- Support global and regional efforts to improve labelling processes, which may include establishing a repository of process documentation, data entry and remediation exercises, developing process maps, and assessing appropriateness of Viatris written standards.- Serve as SME in charge of offering direction on artwork labelling interphase and needs, labelling change controls and E2E tracking timelines and actions.- Any other assigned duties as appropriate.

About Your Skills & Experience- Must possess:
- Proficiency in speaking, comprehending, reading and writing English.-
- IT literate with excellent proficiency in using word, excel, power point, Visio.Preferred Qualifications

If you have the following characteristics, it would be a plus:
- Previous experience of Document Management Systems and Regulatory Information Systems.- Understanding of GLC requirements/ processes and EU/ US regulatory requirements.- The ability to influence effectively in a matrixed, cross functional team environment.- completed a minimum of their first university degree year and be currently enrolled in an accredited college or university in a life sciences degree course.

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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