Sr Reg Affairs Dir (R1090763) in Durham, NC at IQVIA™

Date Posted: 7/30/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    7/30/2019
  • Job ID:
    R1090763

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.

Senior Global Regulatory Affairs (GRA) Leader for the RIM-Smart GRA installation, including integration of the multiple applications into a single, viable platform for GRA use, as well as representing the future technology-enabled GRA service offerings to external customers and internal (IQVIA) business collaborators.  RIM-Smart is IQVIA’s end-to-end integrated regulatory information management system, including the capabilities of information and submission management, content management and regulatory intelligence.

  • Leader, coordinator, and GRA advocate for the RIM-Smart Project. Role provides leadership and integration working across a wide variety of legacy Quintiles, legacy IMS, and other stakeholders to knit together a number of multiple platforms into a consolidated software offering for GRA. This project includes multiple implementation phases, through 2021.
  • Lead Developer for multiple RFP and business development responses that will showcase the new technology-enabled services of GRA. This central role requires bridging multiple groups of GRA as well as internal and external stakeholders.  The ideal candidate will easily work across the boundaries of legacy organizations, as well as represent GRA at external conferences. 
  • GRA business processes mapping to enable the integration of technology into the business processes. Future work would have included leveraging the technology-enabled business processes into GRA strategic pricing and development in corporate pricing platform.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Possesses broad, global regulatory expertise. Familiar with regulatory information technology platforms and their utilization. 
  • High learning agility.
  • Strong project management skills, as well as working effectively with cross-functional teams. Excellent communication skills (oral and written), as well as interpersonal and and organization skills.
  • Strong software and computer skills, including MS Office applications. 
  • Strong track record of self-motivation and enthusiasm.
  • Competent with negotiation skills and is confident in making decisions with minimal supervision.
  • Ability to work on multiple projects, ensuring on-time delivery with high quality. Independently able to identify, solve and implement process improvements.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience in regulatory affairs and/or regulatory-related technology.

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.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1090763