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2023 Experiential Internship - Global Submission Support (Illinois)


Location: Owensboro, Kentucky
Type: Non-Remote
Posted on: January 19, 2023
**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 SUBMISSION SUPPORT 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 Submission Support (GSS) team provides support for regulatory submissions, agency responses and internal queries associated with the AbbVie global product portfolio. The team coordinates and fulfills document and samples requests required by regulatory agencies to register/market products internationally, maintains complex files and electronic document management systems, and works with cross-functional project teams. The team is currently leading several projects that will increase efficiencies. The GSS intern will experience working on global projects and gain exposure to regulatory affairs across geographies. The Intern will be assigned to support one or more projects and the related organizational change management to ensure adoption of the solutions identified. The GSS Intern will have exposure to Regulatory Affairs, will be assigned similar responsibilities to a full-time Regulatory Affairs Specialist, and will work on special projects as assigned. **KEY RESPONSIBILITIES INCLUDE:** - Provide support in the planning, execution, and follow-up of project meetings. - Assist in the execution of change management and communications strategy for one or more projects, which could include preparation of the program communications or SharePoint site content updates and design. - Create succinct, strategic, yet illustrative presentations to be delivered to key project stakeholders (e.g., program teams, business functions, IT). - Work with the global Regulatory Affairs team members to understand roadmap for completing document requests - Procuring documents from all AbbVie facilities for new product registrations, line extensions, and renewals. - Work directly with third party manufacturing companies (TPMs) to obtain documents - Organize legalization of documents in line with Affiliate requirements - Provide regular and consistent updates on status of requests - Maintain, organize, and ensure protection of proprietary information used in regulatory files - Track payment transactions for document legalizations - Research and locate information on regulatory requirements for similar products or requests **MINIMUM QUALIFICATIONS** - Currently enrolled in university, pursuing a Bachelor’s degree in International Business, Life Science, Organizational Management, or related field - Demonstrated leadership skills (i.e. extracurricular activities or projects) **PREFERRED QUALIFICATIONS** - Ability to identify issues and seek solutions - Ability to work both independently and collaboratively - Strong verbal and written communication skills - Organizational skills to prioritize and plan work, multi-task, and meet schedules - Adaptable and flexible **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: -