摘要
About the Role
Your Key Responsibilities:
- Maintaining regulatory compliant, competitive and up-to-date global labeling documents for assigned products, leading the ELTF to align on labeling strategy, labeling course of action and text.
- Represent global labeling in relevant sub-teams, researching and providing input about labeling topics across different markets, the competition, and regulations.
- Contribute to the creation of high-quality documents supporting changes to the CDS, USPI, EU SmPC and leading responses to labeling-related Health Authority queries.
- Lead the interaction with Country Organizations to ensure the timely implementation of labeling changes in local product information and ensuring consistency and compliance with the CDS.
- Contribute to Global Labeling management and continuous improvement initiatives.
- Review and comment on emerging internal and external guidelines and regulations on labeling topics.
- Represent Global Labeling during audits and inspections, as required
Role Requirements:
Essential Requirements:
- Bachelor’s degree in life science or pharmaceutical sciences. Advanced degree with the requisite experience is desirable.
- Extensive experience (2-3 years) in global labeling (incl. US and EU); alternatively extensive experience (5 years) 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.
Location: Basel, Hybrid working requirement 3 days / 12 days per month in office.
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:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
*Restrictions on flexible working arrangements may apply and will be discussed at interview if applicable
Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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.
