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.
Please only apply if you are a current student or graduated within the last 12 months in a clinical research related program.
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:
This position is classified as non-exempt under the Fair Labor Standards Act; employees are eligible for overtime compensation subject to prior approval.
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 IQVIAs Talent Acquisition team at email@example.com to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare and human health forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled