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
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 and CMC data. As required, this includes locating and confirming the validity of such information.
- Updating the SmPC, confirming compliance with mandated safety triggers, 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 team to learn Regulatory submission strategy relating to proposed changes to the PI texts.
- As required, supporting Regulatory Leads with, but not limited to, responses to questions and requests for further information, which impact PI texts.
- As required, other Labelling activities required to support the business.
About you
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.
- Previous experience of databases and document management systems are 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
