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
Supporting creation, verification, maintenance and/or justification of Safety and Regulatory compliant Product Information (PI) texts (Labelling), and, as required, associated activities, for, but not limited to, Central Regulatory Affairs (CRA) managed group procedures.
Every day, we rise to the challenge to make a difference and here’s how the role will make an impact:
After successful onboarding main accountabilities will be:
- Reviewing of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data. As required, this includes locating and confirming the validity of such information.
- Updating the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.
- Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
- Working with a team to learn Regulatory submission strategy relating to proposed changes to PI texts.
- As required, supporting Regulatory Leads with, but not limited to, responses to questions and requests for further information, which impacts PI texts.
- As required, other Labelling activities were required to support the business.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
- The successful candidate will preferably be currently enrolled in an accredited university in a pharmacy or life sciences degree course or recently completed a similar degree course.
- Excellent IT skills with proficiency in Microsoft applications (especially Excel and PowerPoint).
- Strong written and verbal communication skills are important.
- Previous experience with databases and document management systems is an advantage.
- An interest in project management would be useful.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits At Viatris
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. Some of our benefits include the following on top of a competitive salary:
- Top Employer Accreditation, demonstrating that we provide excellent people policies and practices
- Hybrid work model
- Focus on career progression with growth and development opportunities
- Emphasis on Health & Wellness programmes
- 100% paid medical insurance and Employee Assistance Programme
- Life cover
- 2 paid volunteer days per year
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
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.
