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Regulatory Affairs Operations Intern

Company: AbbVie
Location: Sunnyvale
Posted on: February 16, 2020

Job Description:

As an AbbVie Summer Intern, you will participate in a paid, ten-week summer program that is focused on providing students with robust projects throughout the summer. As an intern, you will be located at our office in Sunnyvale, CA, with housing and shuttle services for eligible students. General Position: Regulatory Affairs Operationssummer internship program provides the opportunity to gain first-hand experience with the different functional areas/teams within Regulatory Affairs/ Operations organization as well as broad exposure to various roles within the industry. The program accentuates the growth and development of its participant by providing networking opportunities, career development and involvement in projects that make a significant contribution to the Regulatory Affairs organization.Assignment Details:

  • Understand the various roles, processes and industry standards and provide Regulatory Affairs/Regulatory Operations support
  • Develop knowledge of other roles and functions within R&D and cross-functional teams; Apply this knowledge to help support Regulatory Operations function
  • Work with the Regulatory Operations team to assist in document management and submission activities, including archiving of Regulatory submissions documentation, including tracking and extracting metrics
  • Aptitude to learn the role of Regulatory technology (Regulatory Systems) within Regulatory Affairs organization and the impact within the broader Regulatory, R&D organization
  • Support Regulatory Systems and processes including migration/importation of documentation
  • Support Submission activities by engaging in day to day tasks (e.g. preparing submission documents, tracking, filing, etc.) associated with submission preparation and dispatch of Regulatory Authority submissions.
  • Apply organization skills and collaborate within Regulatory Affairs department
  • Contribute to Regulatory and/or cross departmental operational guides and proceduresBasic:
    • Completed at least one year of college education before beginning internship
    • Currently enrolled and in good standing at an accredited University graduate program
    • Undergraduate or Graduate Level Student
    • Be an active student in good standing at an accredited university
    • Maintain a minimum cumulative GPA of 3.0/4.0 or equivalent
    • Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT can be accommodated).Preferred:
      • Must be current college student (sophomore or higher) with a major in either Life Sciences, Information Technology or Business.
      • Strong written, oral and analytical skills
      • Adept time management skills
      • Proficient in MSOffice programs and Adobe Acrobat
      • Technical aptitude; Enjoys learning and working with software applications Final Presentation: Each Intern is expected to prepare a short presentation to their team to share what they have learned through their internship and how they hope their new knowledge will help them secure their future career. Presentations should be 10-15 minutes long and should include visual aid (posters or PowerPoint) .

Keywords: AbbVie, Sunnyvale , Regulatory Affairs Operations Intern, Other , Sunnyvale, California

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