Senior Regulatory & Start Up Specialist, cFSP

IQVIA Argentina; Ciudad de México; A distancia; USD 30,000 - 45,000; Jornada completa

Descripción de la vacante

A leading global provider in clinical research services seeks a Regulatory & Start Up Specialist to oversee site management from feasibility through closure. The role requires a Bachelor's degree in a relevant field and a minimum of three years in the biopharmaceutical industry, including expertise in EC submissions within Mexico.

Formación

• 3+ years of experience in biopharmaceutical/CRO industry with EC submission experience in Mexico.
• Ability to manage multiple tasks and meet deadlines.
• Experience in customizing ICF.

Responsabilidades

• Participate in end-to-end site management from feasibility to site closure.
• Support Ethics Committee and Regulatory Authority submissions.
• Track assigned activities and produce reports as needed.

Conocimientos

Fluent English

Interpersonal Skills

Detail Oriented

Goal Oriented

Negotiation Skills

Educación

Bachelor’s Degree in Life Science, Business Administration, Finance

Herramientas

Microsoft Office

Veeva Vault

Descripción del empleo

• Regulatory & Start Up Specialist, cFSP.

  Location: Mexico - Full home based

  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. This includes supporting site qualification, site level regulatory green light and site maintenance/close-outs.

  Essential Functions

• Participate in development of in-house model process documents.

• For assigned sites and countries, serve as a primary site contact for end-to-end study activity.

• Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.

• Utilize systems and tools to track assigned activities and produce reports and metrics as needed.

• Oversee essential document collection, tracking & review.

• Support the collection of country and site level intelligence

• Support Ethics Committee and Regulatory Authority submissions

• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate or maintain sites for a study as appropriate.

• Qualifications

• Bachelor’s Degree in Life Science, Business Administration, Finance or related field or work experience equivalent.

• Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, including experience in EC submission in Mexico.

• ICF customization experience

• Fluent English: written and oral communication skills

• Proficiency with Veeva Vault and all applications of Microsoft Office.

• Ability to negotiate complex contract and payment terms.

• Goal oriented, self-starter with proven ability to work independently.

• Able to proactively identify issues and provide potential solutions for resolution.

• Detail oriented.

• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.

• Good interpersonal skills

IQVIA 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. Learn more at https://jobs.iqvia.com