• Regulatory Affairs Intern Jobs in United States Of America - 25367933

  • Iqvia
  • United States Of America, Usa
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward

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 (eg, 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

Must be currently enrolled in a college or university degree and have completed at least one semester of study or have graduated within the past year
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

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage It takes brave minds, pushing the boundaries to transform healthcare Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients

Forge a career with greater purpose, make an impact, and never stop learning

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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 workday_recruitingiqviacom to arrange for such an accommodation

Job ID R1099114

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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