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2023 Experiential Internship - Global Regulatory Strategy Infrastructure (Illinois)


Location: Owensboro, Kentucky
Type: Non-Remote
Posted on: January 19, 2023
This job is no longer available from the source.
**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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.  **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. Skills: Salary: -