Labeling Compliance Coordinator Hatfield, East of England, England
Viatris
Full Time
Hatfield, East of England, England
38092 - 50016 GBP ANNUAL Today
Job description
1478 Generics [U.K.] Ltd.
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.
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.
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
The Labelling Compliance Lead is a member of the Global labelling organisation and responsible for monitoring and supporting compliant labelling processes across all regions and markets.
In this role the individual will be responsible for E2E labelling tracking and driving continuous process improvement processes for all regions through establishing a consistent culture of labelling quality and compliance.
Every day, we rise to the challenge to make a difference and here’s how the Labelling Compliance Lead role will make an impact:
- Responsible for oversight of compliance with global labelling processes and supporting associated regional labelling for inspection readiness. This includes tracking of labelling updates, deviations, and management of change control records.
- Develop metrics and reporting that support Global Labelling Compliance monitoring. This will require managing a dashboard to make visible that labelling deliverables have appropriate KPI’s which are tracked reviewed and communicated according to plan.
- Identify potential risks, along with rationales and anticipated likely outcomes, facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified goals through an agile way of working and active collaboration with team leads
- Proactively identify challenges and facts that are subject to applicable laws, regulations, guidelines, and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines, and enforcement trends; fraud and abuse laws and HCC policy) and help develop alternatives to avoid any misperception in the respective communication while achieving the desired communication outcome outcomes
- Assist with producing and maintaining SOPs and other written standards outlining labelling procedures and best practices to guarantee international compliance
- Direct and support global and regional efforts to improve labelling processes, which may include establishing a repository of process documentation, 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
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Science, Medicine or Pharmacy, or another related field
- 3 or more years Labelling, Regulatory Operations experience
- Regulatory experience including in depth Labelling knowledge
- Highly developed interpersonal, presentation and communication skills
- High level of confidence in manipulating Regulatory datasets and creating reporting solutions from Regulatory Information Management Systems.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
If you have the following characteristics, it would be a plus:
- Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy.
- Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
- Understand GLC requirements/ processes and EU/ US regulatory requirements.
- The ability to influence effectively in a matrixed, cross functional team environment.
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.
What we offer:
- Top Employer Accreditation, demonstrating that we provide excellent people policies and practices
- Competitive compensation package inclusive of annual discretionary bonus
- Focus on career progression with growth and development opportunities
- Hybrid work model
- Emphasis on Health and Wellness programmes
- 100% paid medical insurance and Employee Assistance Programme
- Life cover
- Excellent employer-matched pension scheme with Viatris contributing up to 11%
- 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.
Viatris
www.viatris.com
Pittsburgh, United States
Scott A. Smith
Unknown / Non-Applicable
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
2020
