2025 Global Regulatory Strategy Infrastructure Intern
AbbVie 98000.00 US Dollar . USD Per annum
2024-11-07 17:37:18
North Chicago, Illinois, United States
Job type: fulltime
Job industry: Healthcare & Medical
Job description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Global Regulatory Strategy Infrastructure Intern 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 AbbVies 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:
- EU 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
This internship will be based in North Chicago, IL.
Qualifications
MinimumQualifications
- Currently enrolled in university, pursuing a PharmD degree
- Returning to university for at least one semester following the internship
- Demonstrated leadership skills (i.e., extracurricular activities or projects)
Preferred Qualifications
- Expected graduation date between December 2025 May 2027
- Knowledge and experience with Microsoft Office products, SharePoint, electronic systems, and databases
- Excellent written and oral communication skills
- Excellent organizational and project management skills
Benefits and Amenities
- Competitive pay
- Relocation support for eligible students
- Select wellness benefits and paid holiday / sick time
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.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
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