2021 Experiential Internship Regulatory Affairs Labeling Operations Analyst

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 Analyst, Regulatory Affairs Registration and Label Management executes strategies, creates and maintains product registration and label information in source system(s). May be responsible for metrics, reports, metrics and verification of registration and label management data.

Responsibilities :

• Responsible for population of meta data and documents in our Registration and Label
• Management systems such as TRACTS (The Registration and Compliance Tracking System) and GLS (Global Labeling System).
• Develops queries, reports and metrics with oversight.
• Troubleshoots errors and system performance issues.
• Works with peers, manager and IT on business problem resolution and enhancements.
• Participates and contributes in group, department and cross-functional meetings.
• Interacts with all areas of regulatory affairs and affiliates to ensure registration and label management information is current, accurate and available in regulatory systems.
• Executes established business processes, and may assist in development and implementation of process/system changes and/or data remediation projects.
• May indirectly manage the work and/or assist in training of other department members.

Qualifications

Qualifications :

Required Education:

• Bachelor's degree or High School diploma or equivalent and 4 years related experience
• 3.0 minimum GPA
• Returning to university for at least one semester and graduating within one-year post internship
• Demonstrated leadership skills (i.e., extracurricular activities or projects)
• Authorized to work in the U.S. on a permanent basis without requiring sponsorship
• Preferred Education:
  • Bachelor's degree RAC certification
• Required Experience:
  • 2 years pharmaceutical or industry related experience.
  • Experience working in a complex and matrix environment.
  • Strong communication skills both oral and written.
  • Experience/understanding/use of software tools.
  • Keen awareness to cultural nuances; proven ability to work in a global environment.
  • Strong attention to detail and problem-solving skills.
• Preferred Experience:
  • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, Operations, or related area.
  • Understanding of global regulations.
  • NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.

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.