2023 Experiential Internship - Global Regulatory Strategy Infrastructure (Illinois)
ABOUT ABBVIE
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com.
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GLOBAL REGULATORY STRATEGY INFRASTRUCTURE INTERNSHIP OVERVIEW
Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie’s Experiential Interns.
The Global Regulatory Strategy Infrastructure Intern will support the development of the Global Regulatory Strategy (GRS) Infrastructure framework. Supporting the development of Best Practices (BP) and/or Working Instructions (WI) for GRS to pre-emptively inform processes that will yield optimal probability of success (POS) for achievement of global defined key milestones, designations, and procedures including, but not limited to:
European Union- PRIME, Conditional Marketing Authorization, Accelerated Assessment, Orphan Drug Designation, Pediatric Investigation Plan (PIP), Orphan Exclusivity
Japan- Sakigake, Priority Review, Conditional Early Approval, Orphan Drug Designation, Exclusivity
China- NMPA Pre-Investigational New Drug Consultation (Pre-IND), Breakthrough Medicines, Conditional Approval, Priority Review (Pre-MA Meeting), Special Approval
KEY RESPONSIBILITIES INCLUDE:
Work with Global Regulatory Leads (GRL) and Global Area Leads with prior, relevant regulatory milestone, designation, and procedure experience
Support the development of Best Practices (BP)/Work Instructions (WI)
Employ review teams for finalization of BP/WI
Support the uploading of BP/WI to GRS accessible repository site
Support the BP/WI SharePoint site linkage to relevant product information within the applicable GRS accessible system
MINIMUM QUALIFICATIONS
Must be currently enrolled in university, pursuing a Bachelor’s Degree in Biology, Chemistry, Microbiology, Medical Technology, Pharmacy, Pharmacology, Math, Engineering, Regulatory, Business Management, or related field
Demonstrated leadership skills (i.e., extracurricular activities or projects)
Excellent written and oral communication skills
PREFERRED QUALIFICATIONS
Knowledge and experience with Microsoft Office products, SharePoint, electronic systems, and databases
Excellent organizational and project management skill
BENEFITS AND AMENITIES
Competitive pay
Travel, transportation and lodging support for eligible students
EQUAL EMPLOYMENT OPPORTUNITY
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.