Summary
The RA GLM provides strategic and operational regulatory labelling input and works in close collaboration with Expert Labeling Task Force (ELTF) members in maintaining core labeling documents and handling HA or CO labeling queries for assigned products.
About the Role
#LI-Hybrid
Key Responsibilities:
- 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
- Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate
- Represent Global Labeling as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products
- Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
- Contribute to the creation of high-quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries
- Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics
- Represent GL during audits and inspections
Essential Requirements:
- Education: Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred
- 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
- Ability to lead cross-functional teams in a matrix environment
- Organizational awareness (interrelationship of departments, business priorities)
- Sound understanding of medical and scientific terminologies
- Good understanding of drug safety information
The salary for this position is expected to range between $119,700 and $222,300 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
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
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
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