Global Labeling Manager (Oncology)

Location: East Hanover, NJ #LI-Hybrid

About the Role:
The RA Global Labeling Manager (GLM) is responsible for the maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned Novartis Innovative Medicines products. The assigned products should in general be of higher complexity products and may include developmental programs.
The RA GLM provides strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members in maintaining core labeling documents and handling Health Authority or Country Organization labeling queries for assigned products.

Key Responsibilities:

• Present to GLC on CDS changes.
• Interact with COs to ensure timely implementation of global labeling changes in local product information and ensure international consistency and compliance with the CDS.
• Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
• Serve as the labeling lead for all labeling related topics.
• Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate.
• Maintain regulatory compliant, competitive and up to date global labeling documents: Core data sheet (CDS), Basic Patient leaflet (BPL), Basic Succinct Statement (BSS) for assigned products.
• Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries
• Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Essential Requirements:

• Education:

Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.

• Organizational awareness (interrelationship of departments, business priorities)
• Good understanding of drug safety information
• Ability to lead cross-functional teams in a matrix environment
• Minimum 2-3 years’ experience in global labeling or other regulatory affairs functions, alternatively 5 years’ experience in related areas of the pharmaceutical industry, or Health Authorities.
• Strong interpersonal, project management, communication, negotiation and problem solving skills.
• Sound understanding of medical and scientific terminologies

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/peopleandculture

The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

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Global Drug Development

REG AFFAIRS GDD

USA

East Hanover, NJ

Novartis Pharmaceuticals

Research & Development

Full Time

Regular

No

Yes