Regulatory & Start Up Specialist 2, Cfsp

hace 7 días

Desde casa, México IQVIA A tiempo completo

**Regulatory & Start Up Specialist, c**FSP - US/CAN Support**

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
- 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

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