Regulatory & Start Up Specialist 2, cFSP

Senior 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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.