Regulatory Technical Expert

Regulatory Technical Expert - propharma group

Datum der Veröffentlichung: Mar 29, 2023

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Auftragsdetails

Ort:

Newark, New Jersey, United States of America
Gesellschaft:

propharma group
Typ:

Full Time/Permanent
Shift:

First Shift (Day)
Karrierelevel:

Experienced Professional
Positionen:

4
Erfahrung:

5 Year
Geschlecht:

Keine Präferenz
Grad:

Bachelors
Vorher bewerben:

Nov 30, 2023

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Job Summary

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Evaluates adequacy of analytical and clinical study designs for IVD EUA use and associated performance data.
Analyzing labeling and procedures to determine appropriate conditions for use and for consistency with performance data.
Drafts review memorandum, decision, summary and other documents as applicable that are consistent with documents the scientific and regulatory basis for the recommended decision, including test design, performance, labeling and associated analysis.
Interacts with EUA sponsor to communicate deficiencies and obtain additional information where needed.

Detailed Description

Qualifications

At least 5 years of IVD industry or regulatory and scientific review experience.
Experience evaluating analytical and clinical methods for evaluating in vitro diagnostics.
Ability to clearly communicate scientific and regulatory rationale for recommendation.
Knowledge of FDA EUA policies, law and IVD EUA template study design and performance expectations.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Auftragsdetails