Senior Regulatory Affairs Officer - Clinical Trials - (1803321) in Great Britain at IQVIA™

Date Posted: 11/1/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Great Britain
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/1/2018
  • Job ID:
    1803321

Job Description

At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
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.

Job Requirements

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

* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute

Job ID: 1803321