Regulatory Affairs Intern (6 months, Office-Based) - IQVIA Biotech

IQVIA Biotech has an excellent intern opportunity for a current student or a recent graduate (within the last 12 months) in a clinical research related program. This intern role will offer extensive experience in regulatory affairs.

This position will be based in the Raleigh/Durham, NC area.

BASIC FUNCTIONS:

The intern will observe and sometimes participate in the functions of day to day operations in a Clinical Research Organization environment, with specific focus on the Regulatory Affairs Group.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Assist Regulatory Affairs Manager, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
• Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects. 
• Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
• Participate in internal and client meetings.
• Filing and retrieving documents, records and reports
• Copying, faxing, mailing and tracking information
• Assisting with creating, modifying, updating and maintaining documents
• Attending internal meetings related to tasks
• Assisting the Regulatory Specialist in preparing reports to include weekly reports and other reports as requested
• Researching FDA website for new guidance, regulations
• Providing support to staff for project-based work
• Assisting in file room as needed
• Perform other related duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Basic knowledge of the clinical research process
• Excellent written and verbal communication skills
• Excellent organizational and time management skills
• Experience in a team/matrix environment
• Exceptional excel and general computer skills
• Demonstrated ability to form strong functional relationships, positive attitude, and ability to interact with all levels of staff to coordinate and execute study activities
• Demonstrated ability to be flexible with the management of multiple tasks and priorities of varying complexity

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very little physical effort required to perform normal job duties (unless otherwise indicated)

CLASSIFICATION:

This position is classified as non-exempt under the Fair Labor Standards Act; employees are eligible for overtime compensation subject to prior approval.

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.