Reg Affairs Officer 2 - Clinical Trials (R1081988) in Livingston, UK at IQVIA™

Date Posted: 11/22/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    11/22/2019
  • Job ID:
    R1081988

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.

PURPOSE

Prepares and/or reviews regulatory
submissions to support clinical trial.

RESPONSIBILITIES

•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 customers.

•Understands the Scope of Work,
deliverables and management of budget for any given project and manages
workload as appropriate.

•May give guidance to junior colleagues,
including feedback on the quality of technical documents, and may assist in
their training 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 Quintiles small groups or individuals.

•Performs other tasks or assignments, as
delegated by Regulatory management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

•Possesses a specific regulatory or
technical expertise

•Good, solid interpersonal communication
(oral and written) and organization 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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Degree in life science-related
discipline or professional equivalent plus at least 3 years relevant experience
desirable however less experience considered.

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.



Job ID: R1081988