Senior Manager, Core Labeling Strategy
Senior Manager, Core Labeling Strategy
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Salary Not Disclosed
1 Vacancy
Job Description
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.
Job title: Senior Manager Core Labeling Strategy
Company: Mylan Inc. (Canonsburg Pennsylvania)
Duties: Lead the preparation review and approval of global labeling documentation (e.g. CCDS Core Patient Information) as well as territorial labeling documentation (e.g. Common EU SmPCs and USPIs) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies. Lead labeling strategy in partnership with Global Regulatory in line with the overall regulatory strategy by providing labeling expertise (labeling regulations internal processes and impact analysis of competitor profiles) for CCDS USPI (including Abbreviated New Drug Applications New Drug Applications and Biologics License Applications) and group managed EU SmPCs (Centralized/Mutual Recognition/Decentralized Procedures) as well as abbreviated PIs thereof. Establish close partnership of labeling leads with project leads and the regulatory matrix to ensure effective strategic and proactive labeling development. Interface directly with senior management and functional experts on business strategy and labeling content. Work closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labeling aspects for the defined portfolio. Lead labeling updates and development critically evaluating the data and principles upon which labeling statements are based to ensure clinical relevance and regulatory acceptance across the portfolio. Work 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. Escalate issues to Global Labeling Committee (GLC) for endorsement of recommendations when an agreement cannot be reached. Apply strong understanding of competitor labels and evolving external labeling trends and agency requirements. Negotiate resolution of complex regulatory and scientific issues manage multiple projects simultaneously and employ sound judgement in solving complex problems. Internally influence key proposed guidelines and regulations to shape external environment. Participate in external facing activities and help represent Viatris in various industry groups (such as DIA Navitas trade associations) EMA (European Medicines Agency) or FDA sponsored events (e.g. Workshops Ad Coms). Telecommuting permitted from anywhere within the United States. Periodic domestic and/or international travel ( <10% of the time).
Requirements: Bachelors degree or foreign equivalent in Science Medicine Pharmaceutical Management or a related field and 5 years of experience in the position offered or related in Labeling and Labeling development or a related field. Must have 5 years of experience with: Applying knowledge of regulatory affairs including in-depth labeling knowledge; Understanding GL (Global Labeling) requirements and processes in the European Union United States and/or Rest of World (ROW) markets and within the label; Reading and interpreting comprehensive and intricate research documents including literature reviews; Writing technical correspondence related to labeling and regulatory compliance; and Working with executives and communicating abstract concepts within a regulatory framework.
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.
Required Experience:
Senior Manager
Employment Type
Full-Time
