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?  http://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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.