Director Core Labeling Strategy

Job description

Mylan Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Every day, we rise to the challenge to make a difference and here’s how the Director Core Labeling Strategy role will make an impact: Provide regulatory labelling leadership, governance, and expertise to Viatris products such that the Product Information texts (labelling) of existing and new products are successfully developed, maintained and implemented globally in compliance with applicable regulatory requirements. In this role the individual will have responsibility for the creation, development, and maintenance of compliant Core Labelling documents including Company Core Data Sheets (CCDS) and associated patient information, as well as oversight of Global Ad Promo and Medical Marketing review and approval, in alignment with Viatris principles and procedures. The role also contributes to strategic labelling development across the product lifecycle, including supporting early development programmes through the development of Target Product Labelling (TPL), competitive labelling analyses and regulatory precedent assessments to support global regulatory strategy and major submissions, including US Prescribing Information (USPI). Key responsibilities for this role include: Accountable for management of the global labelling process and labelling development across the assigned portfolio. Leads preparation, review and approval of global labelling documentation (e.g. CCDS, Core Patient Information) as well as territorial labelling documentation (e.g. Common EU SmPC’s and US Prescribing Information (USPI)) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies. Drives labelling strategy in partnership with Global Regulatory in line with the overall regulatory strategy by providing labelling expertise (labelling regulations, internal processes, competitive labelling analysis and impact assessment of competitor profiles) for 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. Leads development and maintenance of Target Product Labelling (TPL) to guide clinical development strategy, regulatory positioning and cross-functional alignment, particularly for innovative or development-stage assets. Ensures 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 and 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 across both development and lifecycle management activities. 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. Controls global Labelling compliance by reconciling labeling deviations with Company Core Position (e.g. CCDS and corresponding Patient Information) by assessing change requests for labeling documents, driving responses to Health Authorities and other requesting parties, and approving the final outcome. Chairs cross-functional Product Labeling Teams (PLT), including identifying and engaging and engaging ad hoc subject matter experts from relevant support functions as needed. Collaborates closely with Global Medical and Clinical Services and Global Product Safety and Risk Management (PSRM) – Safety Surveillance as well as Clinical Safety Team to ensure that all Product Information (PI) content is authored is scientifically accurate, validated, and aligned with safety and clinical requirements. Where agreement cannot be reached, initiates and manages escalation to the Global Labelling Committee (GLC) for review, decision-making, and implementation in accordance with the global labelling governance framework. Maintains strong awareness of competitor labels, evolving external labelling trends and agency requirements to inform labelling strategy and support product differentiation where appropriate. Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems. Reviews and approves promotional materials with respect to CCDS and relevant codes of conduct according to company requirements and processes and counsels strategic review of competitor and existing Viatris labelling documents as necessary. Reviews, advises on and approves documents from Clinical Development, Medical Affairs, Pharmacovigilance and other scientific functions as appropriate, e.g. Investigator Brochure, documents, periodic reports (such as Clinical Study Protocols, Clinical Study Reports, PSURs, RMP, ACO), and Core Value Dossiers. Internally influences interpretation of emerging regulatory guidelines and proposed regulations impacting labelling strategy. Manages, leads, directs and supervises direct reports, including recruitment, coaching, performance management and development within the Labelling team. Contributes to the leadership of the Global Labelling Organization. Counsels project teams and participate in Regulatory team meetings, representing Labelling Strategy as appropriate. 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). Performs other labelling duties as assigned. The minimum qualifications for this role are: Minimum of a Bachelor's degree (or equivalent) in Science, Medicine or Pharmacy, or another related field with 10 years of regulatory experience, including significant experience in global labelling strategy and development. Preferred candidate will have a Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy. However, a combination of experience and/or education will be taken into consideration. Demonstrated experience in labelling development, including development and maintenance of global core labelling (e.g. CCDS) and major market labelling such as US Prescribing Information (USPI) and EU SmPCs. Demonstrated experience developing first-cycle or initial submission labelling for innovative products in major regulatory markets (e.g., NDA/BLA or MAA submissions) is strongly preferred. Experience in strategic labelling activities such as Target Product Labelling (TPL) development, competitive label benchmarking, and regulatory submission support is considered an advantage. Regulatory experience including in-depth global labelling knowledge across development and lifecycle management. Understand Product Labeling Team (PLT) and Global Labelling Committee (GLC) governance processes and EU and US regulatory labelling requirements, including development and maintenance of EU and US Prescribing Information (USPI) and Company Core Data Sheets (CCDS). Familiarity with competitive labelling assessments and experience in Target Product Labelling (TPL) development to support regulatory strategy. Experience i