Summary
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 Requirements:
- 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? : https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
