Shire Pharmaceuticals Internship -Regulatory Affairs I Job in Lexington, Massachusetts US

Shire Pharmaceuticals Internship -Regulatory Affairs I

Kelly Services is partnering with Shire Pharmaceuticals to offer an exciting internship program with a world-class pharmaceutical organization. Shire is a global specialty biopharmaceutical company focused on the therapeutic areas of attention deficit hyperactivity disorder (ADHD), human genetic therapies, gastrointestinal (GI), and regenerative medicine. Shire?s purpose is to enable people with life-altering conditions to lead better lives. Shire's U.S. Internship Program offers hands-on work experience to students completing their undergraduate and graduate degrees and allows Shire to engage with the local community and discover new and emerging talent. Requirements for the Shire U.S. Internship Program include: Enrollment at an accredited college/university Completion of at least freshman year of undergraduate study by internship start date (Both undergraduate and graduate students that apply will be considered) Major in a field appropriate to the internship Minimum grade point average of 3.0 on a 4.0 scale preferred Legal authorization to work in the U.S. Must be at least 18 years of age Ability to start on one of the designated start dates (see calendar of events below). Please Note: Shire will accept and consider intern applications from relatives of employees; however, individuals will not be hired if they are in the direct line of supervision of a relative or if there is a work-related conflict of interest. The Regulatory Affairs Internship candidate will be responsible for: · Under the guidance of a member of the Regulatory Strategy and Liaison team, projects/tasks/Assignments to include: o Assist w/ Investigational New Drug (IND) filings/maintenance o Maintenance of trial master files (TMF) o Clinicaltrials.gov-creation/maintenance to ensure filings are accurate/up-to-date o Assist team with processing Regulatory-related submissions o Other projects/tasks as assigned. o Complete and present a final project. o Topic to be agreed between intern and Reg/Strategy team member REQUIRED SKILLS: · Good organizational skills; attention to detail; interest in developing an understanding of the Regulatory Affairs function and its role in the drug development process. · MS Office-MS Word · Additional MS Office skills helpful, e.g., Excel If you are interested in this fantastic Summer internship opportunity and meet the requirements of the program, apply at today! About Kelly Services Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a world leader in human resources solutions headquartered in Troy, Michigan, offering temporary staffing services, outsourcing, vendor on-site and full-time placement to clients on a global basis. Kelly provides employment to more than 750,000 employees annually, with skills including office services, accounting, engineering, information technology, law, science, marketing, creative services, light industrial, education, and health care. Revenue in 2007 was $5.7 billion. For more public information on Kelly Services, visit our Web site or read our news releases and privacy statement.