Senior Manager, Core Labeling Strategy

Mylan • Canonsburg, PA

108d • Remote

About The Position

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.

Requirements

• Strong understanding of labeling regulations and internal processes.
• Experience with regulatory submissions including CCDS, USPI, and EU SmPC's.
• Ability to critically evaluate data and principles for labeling statements.
• Strong negotiation skills to resolve complex regulatory and scientific issues.
• Experience managing multiple projects simultaneously.

Nice To Haves

• Experience in external facing activities and representing a company in industry groups.
• Familiarity with evolving external labeling trends and agency requirements.

Responsibilities

• 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 SmPC's and USPI's) 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 for CCDS, USPI, and group managed EU SmPC's.
• 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, or FDA sponsored events.

Benefits

• Telecommuting permitted from anywhere within the United States.
• Periodic domestic and/or international travel may be required.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Food and Beverage Retailers