Regulatory Affairs Associate - (R1014912) in Research Triangle Park, NC at IQVIA™

Date Posted: 5/5/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

  • 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.

Job Requirements

  • Degree in life science-related discipline or professional equivalent
OR
  • High school diploma plus at least 3-5 years experience
OR
  •  Combination of education, training and experience
AND 
  • 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 guidances 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
  • Requires at least 1-2 years of eCTD regulatory publishing experience

 
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1014912