Reg Affairs Officer (1 Year Contract) (R1093607) in Hanoi, Vietnam at IQVIA™

Date Posted: 9/27/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Experience:
    Not Specified
  • Date Posted:
    9/27/2019
  • Job ID:
    R1093607

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.

Responsibilities:

  • Creates an inventory of appropriate regulatory documents based on checklists prepared by Regulatory personnel.
  • Identifies project needs, tracks project timelines and implements client requests, with senior review.
  • Reviews documents for regulatory completeness, consistency and accuracy, interacts with project team members to assure completeness, as necessary.
  • With oversight may draft text for straightforward regulatory documents, and conduct QC review of documents prepared by the regulatory unit, project team or client.
  • Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff.
  • May work independently with internal clients and may interact with external clients, under guidance of senior staff.
  • Assists with project budget, project management, business development activities and other tasks as required by senior Regulatory team members.
  • May address technical issues with documents and offer assistance to staff.
  • Performs other tasks or assignments, as delegated by Regulatory management

Requirements:

  • Degree in life science-related discipline or professional equivalent
  • 1 year working experience in regulatory affairs
  • Good, solid interpersonal communication (oral and written) and organization skills
  • Strong software and computer skills, including MS Office applications
  • Above average attention to detail and accuracy
  • Working knowledge of regulations and guidance relevant to the area of expertise
  • Ability to work on multiple projects, with direction from senior staff as appropriate
  • Ability to adapt quickly to a rapidly changing environment
  • Ability to follow SOPs consistently
  • Ability to make decisions on discrete tasks under senior supervision
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients

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: R1093607