As Senior Global Labeling Manager (Sr. GLM), you will be responsible for the creation and maintenance of regulatory compliant, competitive, and up-to-date high quality and timely implemented core labeling documents (incl. Core Data Sheet (CDS)) and key country labeling (incl. US and EU) for assigned Novartis Innovative Medicines products. The assigned products will include higher complexity products and may include more than one developmental program.
The RA Sr. GLM provides strategic and operational regulatory labeling input, working in close collaboration with Expert Labeling Task Force (ELTF) members in creating and/or maintaining core labeling documents, key labeling, and for handling Health Authority or Country Operations labeling queries for assigned products.
This role offers hybrid working, requiring 3 days per week / 12 days per month in our White City, London office. About the Role
Major accountabilities: As Senior Global Labeling Manager, you will be responsible for: Maintaining regulatory compliant, competitive and up-to-date global labeling documents for assigned products and development programs, leading the ELTF to align on labeling strategy, labeling course of action and text. Representing Global Labeling in relevant sub-teams, researching and providing input about labeling topics across different markets, the competition, and regulations. Contributing to the creation of high-quality documents supporting changes to the CDS, USPI, EU SmPC and leading responses to labeling-related Health Authority queries. Leading the interaction with Country Organisations to ensure the timely implementation of labeling changes in local product information and ensuring consistency and compliance with the CDS. Providing input and influencing emerging labeling and regulatory internal and external guidelines and practices. Contributing to projects and initiatives to advance and enhance capabilities and process within the organization. Mentoring new team members and/or less experienced GLMs. Representing Global Labeling during audits and inspections, as required. Minimum Qualifications: Bachelor’s degree in life science or pharmaceutical sciences. Advanced degree with the requisite experience is desirable. Extensive experience in global labeling (incl. US and EU), or in related areas of the pharmaceutical industry or Health Authorities. Strong interpersonal, project management, communication, negotiation and problem-solving skills. Ability to lead cross-functional teams in a complex, matrixed work environment. Compliance and Quality mindset. Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Commitment to Diversity & Inclusion : Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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The RA Sr. GLM provides strategic and operational regulatory labeling input, working in close collaboration with Expert Labeling Task Force (ELTF) members in creating and/or maintaining core labeling documents, key labeling, and for handling Health Authority or Country Operations labeling queries for assigned products.
This role offers hybrid working, requiring 3 days per week / 12 days per month in our White City, London office. About the Role
Major accountabilities: As Senior Global Labeling Manager, you will be responsible for: Maintaining regulatory compliant, competitive and up-to-date global labeling documents for assigned products and development programs, leading the ELTF to align on labeling strategy, labeling course of action and text. Representing Global Labeling in relevant sub-teams, researching and providing input about labeling topics across different markets, the competition, and regulations. Contributing to the creation of high-quality documents supporting changes to the CDS, USPI, EU SmPC and leading responses to labeling-related Health Authority queries. Leading the interaction with Country Organisations to ensure the timely implementation of labeling changes in local product information and ensuring consistency and compliance with the CDS. Providing input and influencing emerging labeling and regulatory internal and external guidelines and practices. Contributing to projects and initiatives to advance and enhance capabilities and process within the organization. Mentoring new team members and/or less experienced GLMs. Representing Global Labeling during audits and inspections, as required. Minimum Qualifications: Bachelor’s degree in life science or pharmaceutical sciences. Advanced degree with the requisite experience is desirable. Extensive experience in global labeling (incl. US and EU), or in related areas of the pharmaceutical industry or Health Authorities. Strong interpersonal, project management, communication, negotiation and problem-solving skills. Ability to lead cross-functional teams in a complex, matrixed work environment. Compliance and Quality mindset. Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Commitment to Diversity & Inclusion : Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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