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Regulatory and Business Development Specialist

hace 2 meses


Ciudad de México, Ciudad de México IQVIA Argentina A tiempo completo

Job Overview

This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members.

Key Responsibilities

  1. Develop and implement site qualification processes to ensure compliance with regulatory requirements.
  2. Serve as a primary site contact for end-to-end study activity, providing cross-functional teams with detailed updates related to study and site activity.
  3. Participate in all assigned Study Site Management study team meetings, providing detailed updates related to study and site activity.
  4. Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
  5. Oversee essential document collection, tracking, and review.
  6. Support the collection of country and site level intelligence.
  7. Support Ethics Committee and Regulatory Authority submissions.
  8. Complete, manage, and/or support country and site-specific activities required to activate or maintain sites for a study as appropriate.

Requirements

  1. Bachelor's Degree in Business Administration, Finance, Science, or related field or work experience equivalent.
  2. Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, including experience in EC submission in US.
  3. Fluent English: written and oral communication skills.
  4. Proficiency with Veeva Vault and all applications of Microsoft Office.
  5. Ability to negotiate complex contract and payment terms.
  6. Goal-oriented, self-starter with proven ability to work independently.
  7. Able to proactively identify issues and provide potential solutions for resolution.
  8. Detail-oriented.
  9. Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
  10. Good interpersonal skills.

About IQVIA Argentina

IQVIA Argentina is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.