Reg Affairs Officer (R1117350) in Warsaw, PL at IQVIA™

Date Posted: 2/4/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Warsaw, PL
  • Experience:
    Not Specified
  • Date Posted:
    2/4/2020
  • Job ID:
    R1117350

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 and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.

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 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

•Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high school diploma plus at least 7-9 years experience* (*or combination of education, training and experience)

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: R1117350