$146,300 to $234,100pyear; bonus/equity: variable;...
On-site
Company core data sheet (ccds)
Us prescribing information (uspi)
Eu cp summary of product characteristics (smpc)
You will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products
Job Summary
You will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products.
The role offers high strategic visibility in a global role at the interface of science, regulation and patient impact, with close collaboration with senior leaders and cross-functional experts.
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce.
Matching Summary
You will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products.
Salary
$146,300 to $234,100/year; Bonus/Equity: Variable; Benefits: Comprehensive package
Skills & Requirements
Must-have
Company Core Data Sheet (CCDS)
US Prescribing Information (USPI)
EU CP Summary of Product Characteristics (SmPC)
Global life cycle management
Cross-functional Labeling Teams
Nice-to-have
Agile, science-driven environment
Ownership, innovation, integrity
Continuous learning culture
Key Requirements
9-16 years professional experience
Biologics, Vaccines and/or Small Molecules
Strategic Labeling content development
Interacting with Health Authorities
In depth knowledge of EMA and FDA regulatory requirements
Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent