IQVIA
Regulatory & Start Up Specialist 2, cFSP
Mexico · Work style not stated · Full time
Apply on the employer’s site ↗See how well you match this job
You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.
About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerIQVIA
- LocationMexico
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
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.
Show full description
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.
Check your resume against this job Free, no sign-up. Nothing you paste is stored.
Staying safe while you apply
- Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
- Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
- Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.
Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.
Preparing for this role with ROLIVA
- Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
- Prepare honestly.
Build interview stories and application drafts from your own evidence.
- Keep track.
Save the role and record your own application status and follow-ups.
At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked