Auftragsdetails

Senior Regulatory Reviewer - propharma group

Datum der Veröffentlichung: Mar 29, 2023
Login to View Salary

Auftragsdetails

  • Ort:
    Newark, New Jersey, United States of America
  • Gesellschaft:
  • Typ:
    Full Time/Permanent
  • Shift:
    First Shift (Day)
  • Karrierelevel:
    Experienced Professional
  • Positionen:
    5
  • Erfahrung:
    10 Year
  • Geschlecht:
    Keine Präferenz
  • Grad:
    Bachelors
  • Vorher bewerben:
    Nov 30, 2023

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.

Detailed Description

  • This is a year or longer contract that can be conducted remotely with visits to the FDA when needed.
  • The Senior Reviewer is a regulatory and technical reviewer who is responsible for ensuring that final recommendations regarding the device made by the technical experts are appropriately evaluated, organized, and documented before documents are sent to the FDA.
  • Serve as a scientific and regulatory resource for Technical experts for the purpose of providing direction and feedback.
  • Oversee the consistent application of policy, and high-quality work products.
  • The Senior Reviewer will review the memo and all other applicable documents drafted by the technical experts to determine whether the scientific basis for the recommendations is adequately justified and clearly communicated.
  • Provides guidance on novel or complex issues and provides senior level review for work products.

 

Qualifications

  • 20 years of IVD scientific and regulatory experience including at least 10 years as a supervisor.
  • Leadership experience in an organization reviewing IVD EUA's and COVID-19 IVD EUA's in a particular.
  • Hold an MD or PHD in Microbiology, Virology, Chemistry, or related field.
  • Experience providing oversight for evaluation for analytical and clinical studies for in vitro diagnostics.

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.

Fähigkeiten benötigt

Job is expired

Company Overview

Berlin, Berlin, Germany

ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More

Verwandte Jobs

Google Karte