Reg Affairs Officer 2 - (R1034419) in Reading, UK at IQVIA™

Date Posted: 11/9/2018

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.
  • Acts as a Regulatory Team Leader on more complex projects, which may include technical writing.
  • Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
  • Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatoryissues, present lessons learned and discuss customer comments.
  • Understands the Scope of Work, deliverables and management of budget for any given project and manages workload asappropriate.
  • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in theirtraining and development.
  • May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.
  • May act as reviewer for regulatory SOPs, as assigned and appropriate.
  • May prepare and deliver regulatory training to IQVIA small groups or individuals.
  • Performs other tasks or assignments, as delegated by Regulatory management.

Job Requirements

  • Possesses a specific regulatory or technical expertise
  • Good, solid interpersonal communication (oral and written) and organisation skills
  • Strong software and computer skills, including MS Office applications
  • Demonstrates self-motivation and enthusiasm
  • Demonstrates negotiation skills and is confident in making decisions with minimal supervision
  • Ability to work on several projects, retaining quality and timelines
  • Ability to follow SOPs consistently; provides independent thought to assist in process improvements
  • Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high schooldiploma plus at least 7-9 years experience* (*or combination of education, training and experience)
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Travel will be required
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: R1034419