ViatrisSenior Manager, Core Labelling Strategy
McDermott Laboratories Limited
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
The position provides regulatory labelling leadership, governance, and expertise to Viatris products such that the Product Information texts (labelling) of existing and new products are successfully developed and maintained globally.
In this role the individual will have responsibility for the development, creation, and maintenance of compliant Core Labelling documents including Global Ad Promo review and approval, in alignment with Viatris principles and procedures.
Every day, we rise to the challenge to make a difference and here’s how the Senior Manager Core Labeling Strategy role will make an impact:
Accountable for management of the labelling process and labelling development.
Leads development, preparation, review and approval of global labelling documentation (e.g. Target Product Label, CCDS, Core Patient Information) as well as territorial labelling documentation (e.g. Common EU SmPC’s and USPI’s) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies
Leads labelling strategy in partnership with Global Regulatory in line with the overall regulatory Strategy by providing labelling expertise (labelling regulations, internal processes, and impact analysis of competitor profiles) for TPL, CCDS, USPI (including Abbreviated New Drugs Applications, New Drug Applications and Biologics License Applications) and group managed EU SmPC’s (Centralized / Mutual Recognition / Decentralized Procedures) as well as abbreviated PIs thereof.
Establishes close partnership of labelling leads with project leads and the regulatory matrix to ensure effective, strategic, and proactive labelling development. Interfaces directly with senior management, functional experts, on business strategy and labelling content.
Works closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labelling aspects for the defined portfolio.
Leads labelling updates and development, critically evaluating the data and principles upon which labelling statements are based to ensure clinical relevance and regulatory acceptance across the portfolio.
Chairs Product Labeling Team, ensuring appropriate membership by addressing need for ad hoc members from supportive functions as necessary and Working with Global Medical and Clinical Services and Global Product Safety and Risk Management (PSRM) – Safety Surveillance as well as Clinical Safety Team contact to ensure that the content of PI texts authored is verified and agreed with respective disciplines. Where agreement cannot be reached, escalation of the issue to Global Labelling Committee (GLC) for endorsement of recommendations.
Commercially astute, with a strong understanding of competitor labels and evolving external labelling trends and agency requirements.
Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems.
Internally, influences key proposed guidelines and regulations to shape external environment.
May be active in external facing activities and is effective at representing Viatris in various industry groups (such as e.g., DIA, Navitas, trade associations) or at EMA (European Medicines Agency)- or FDA-sponsored events (e.g., Workshops, Ad Coms).
Reviews and approve promotional materials with respect to CCDS and relevant code of conduct according to company requirements and processes and counsels strategic review of competitor and existing Viatris Labeling documents, as necessary.
Might need to manage direct reports, recruit, and motivate within the Labelling team. Contribute to the leadership of the Labelling Organization and drive effective governance through the GLC processes.
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:
Bachelor’s degree in science/medicine/pharmacy (or related field) with extensive years of experience, including many years in labelling; advanced degree preferred.
Prior leadership experience or willingness to lead direct reports.
Strong regulatory background, including in-depth labelling knowledge and understanding of GLC, EU, and US regulatory requirements.
Excellent interpersonal, presentation, and communication skills with ability to influence in a matrixed, cross-functional environment.
Ability to provide innovative, compliant labelling recommendations aligned with corporate goals.
Ability to work autonomously and potentially supervise employees in line with organizational policies and laws.
Ability to interpret complex research, write scientific/technical documents, and communicate abstract concepts to senior leaders.
Strong analytical and reasoning skills to solve moderately complex problems and draw inferences.
Proficiency with basic mathematical computations (percentages, ratios, rates).
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:
Excellent career progression opportunities
Work-life balance initiatives
Bonus scheme
Health insurance
Pension
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.