Regulatory & Start Up Specialist 2, cFSP - Mexico City, Mexico

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 Business Administration, Finance, science 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 US.

• 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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com