1100 Mylan Pharmaceuticals Inc.
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:
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
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Access – Providing high quality trusted medicines regardless of geography or circumstance;
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Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
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Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the role will make an impact:
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Accountable for management of the labelling process and labelling development.
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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 USPI’s) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies
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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 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.
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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.
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Works closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labelling aspects for the defined portfolio.
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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.
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Working with Global Product Safety and Risk Management – Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Global Labelling Committee (GLC) for endorsement of recommendations.
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Commercially astute, with a strong understanding of competitor labels and evolving external labelling trends and agency requirements
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Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems.
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Internally, influences key proposed guidelines and regulations to shape external environment.
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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).
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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.
Key responsibilities for this role include:
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Minimum of a Bachelor's degree (or equivalent) in Science, Medicine or Pharmacy, or another related field with 7-10 years of experience and 5 or more years of Labelling and Labelling development experience. Preferred candidate will Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy. However, a combination of experience and/or education will be taken into consideration.
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Prior leadership experience with direct reports or willingness to lead others. Regulatory experience including in-depth Labelling knowledge. Understand GLC requirements/ processes and EU/ US
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Highly developed interpersonal, presentation and communication skills. Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations. The ability to influence effectively in a matrixed, cross-functional team environment
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Position functions autonomously. The position may directly supervise employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
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Ability to perform computations such as percentages, ratios, and rates.
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Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
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Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required.
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May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.
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Normal office situation or work remote.
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Proficiency in speaking, comprehending, reading and writing English is required.
The external posting salary range for USA10028 is $96,000 - $187,000.
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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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
#LI-Remote
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