Senior Manager, Core Labelling Strategy

Benefits

Additional Information

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 gove