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Clinical Scientist, Assoc Dir (R1066261) in Durham, NC at IQVIA™

Date Posted: 5/25/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Date Posted:
    5/25/2019
  • Job ID:
    R1066261

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.

PURPOSE

The Clinical Scientist position is intended for an individual aspiring to lead full product development programs within the pharmaceutical industry.  To this end, the incumbent will have responsibility for preparation of various work products of the Strategic Drug Development group that are part of  product development process (including preparation of  integrated product development plans, clinical trial applications, sections of Investigational New Drug applications, preclinical and clinical study protocols, investigator brochures, supporting statistical documents, integrated clinical/statistical final study reports, and sections of marketing applications.)


RESPONSIBILITIES

Duties of the Clinical Scientist include but are not limited to:
• Leading in the development of proposals for potential clients
• Providing standardized templates for proposals and key deliverable outputs
• Researching current literature to assist in the drug development lead in preparation for all deliverables, including current product label, treatment guidelines, competitive landscape assessments and standard of care.
• Contributing to various sections of investigational brochures; summarizes animal and clinical studies, and draws conclusions as to the potential safety of the drug under study.
• Assisting in writing documents to support regulatory submissions including, but not limited to, protocol synopses, clinical trial authorizations (INDs, CTAs), marketing authorization applications (NDAs, BLAs, NDSs, MAAs), device authorizations (IDEs, 510Ks, PMAs).
PURPOSE

The Clinical Scientist position is intended for an individual aspiring to lead full product development programs within the pharmaceutical industry.  To this end, the incumbent will have responsibility for preparation of various work products of the Strategic Drug Development group that are part of  product development process (including preparation of  integrated product development plans, clinical trial applications, sections of Investigational New Drug applications, preclinical and clinical study protocols, investigator brochures, supporting statistical documents, integrated clinical/statistical final study reports, and sections of marketing applications.)


RESPONSIBILITIES

Duties of the Clinical Scientist include but are not limited to:
• Leading in the development of proposals for potential clients
• Providing standardized templates for proposals and key deliverable outputs
• Researching current literature to assist in the drug development lead in preparation for all deliverables, including current product label, treatment guidelines, competitive landscape assessments and standard of care.
• Contributing to various sections of investigational brochures; summarizes animal and clinical studies, and draws conclusions as to the potential safety of the drug under study.
• Assisting in writing documents to support regulatory submissions including, but not limited to, protocol synopses, clinical trial authorizations (INDs, CTAs), marketing authorization

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™

QVIA 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: R1066261