JobsEQ by Chmura Logo

2023 Experiential Internship - Regulatory Affairs Submission Management (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.  **REGULATORY AFFAIRS SUBMISSION MANAGEMENT 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. **KEY RESPONSIBILITIES MAY INCLUDE:** - Manage low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency. - Act as Regulatory Affairs (RA) Submissions support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables. - Participate in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipate obstacles and proposes solutions within the team. - Coordinate submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Help prepare content planner for publishing and works with vendor to resolve publishing issues. - Facilitate the creation or procurement of submission content deliverables such as cover letters and forms. - Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. - Contribute to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Contribute to the implementation of internal process and standards documents relating to publishing and publishing deliverables. - Suggest and contribute to process improvements, including changes to software and business processes. May participate on internal project teams to update business software. - Demonstrate ability to influence without direct authority. Build and maintain positive relationships internally and externally. **MINIMUM QUALIFICATIONS** - Currently enrolled in university, pursuing a Bachelor’s or Master’s Degree in Biology, Biochemistry, Chemistry, Chemical Engineering or related field - Must be enrolled in university during the internship period - Must be flexible in a fast-paced, timeline-driven and regulated environment - Basic knowledge of Microsoft Office tools **PREFERRED QUALIFICATIONS** - Experience with publishing related software tools such as Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat. **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: -