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

Date Posted: 7/1/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Great Britain
  • Job Type:
  • Experience:
    At least 5 year(s)
  • Date Posted:
    7/1/2018
  • 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 and marketing authorisation activities for either internal and/or external clients. Independently provides regulatory support for more complex projects.
 
RESPONSIBILITIES
  • Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
  • Competently writes regulatory and/or technical documents with minimal review by senior staff.
  • Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
  • Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff 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 at bid defence meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff.
  • May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate.
  • May be involved in a Regulatory and/or Quintiles Initiative.
  • Performs other tasks or assignments, as delegated by Regulatory management.


Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Demonstrates comprehensive regulatory or technical area of expertise
  • Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
  • Strong software and computer skills, including MS Office applications
  • Demonstrated skills in chairing small meetings
  • Ability to work on several projects, retaining quality and timelines and can prioritise workload with minimal supervision
  • Ability to propose revisions to SOPs or suggest process improvements for consideration

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years experience* (*or combination of education, training and experience)

PHYSICAL REQUIREMENTS

  • 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
* 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