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. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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 associated Working Instructions (WI) for GRS to pre-emptively inform processes to yield optimal probability of success (POS) for achievement of defined US milestones, designations, and procedures. Key milestones, designations, and procedures include, but are not limited to US Breakthrough Therapy Designation, Accelerated Approval, Priority Review, Fast Track, Orphan Drug Designation, Pediatric Exclusivity, Pediatric Study Program (PSP), and Pre-IND Meetings  

Responsibilities:

•Work with Global Regulatory Leads (GRL) and US/Canada Area Leads with prior, relevant US 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 (i.e., Quality Dossier Process SharePoint Site)

•Support the BP/WI SharePoint site linkage to relevant product information within a GRS accessible system

Qualifications

Preferred Qualifications:

•Knowledge and experience with Microsoft Office products, SharePoint, electronic systems, and databases

•Excellent written and oral communication skills

•Excellent organizational and project management skill

Minimum Qualifications:

• Minimum GPA = 3.0/4.0
• Returning to university for at least one semester
• Must be currently enrolled in university, pursuing a bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology, or other), math, engineering, regulatory, business management, or related field
• Demonstrated leadership skills (i.e., extracurricular activities or projects)
• Must be authorized to work in the US on a permanent basis without requiring sponsorship

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Internship
Schedule
Full-time
Job Level Code
IC
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.