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McKesson
McKesson
Sponzor vizuma H1BLogistikaSvetovanjeZdravstveno varstvo

McKesson je zdravstveno podjetje, ki deluje na področju distribucije farmacevtskih izdelkov, medicinskih pripomočkov in zdravstvenih storitev. Njegovo delo lekarnam, klinikam, zdravstvenim sistemom in pacientom pomaga zagotavljati dostop do ključnih terapij, hkrati pa podpira učinkovitejše delovanje zdravstva in odporen odziv na pomanjkanje zdravil.

Podjetje razvija tudi programsko opremo za upravljanje lekarn, svetovalne storitve in tehnološke rešitve za specializirane prakse. McKesson sodeluje z biofarmacevtskimi organizacijami ter podpira onkološke in biofarmacevtske prakse s storitvami, osredotočenimi na dostop do zdravil, upoštevanje zdravljenja, komercializacijo, podatkovno podprte vpoglede in dokaze iz resničnega sveta.

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Delovna mesta v podjetju

Research Regulatory Affairs Specialist – Tennessee

Support FDA, GCP, and IRB compliance for oncology clinical trials at Sarah Cannon Research Institute. Coordinate regulatory documentation and audit readiness with sponsors, research sites, and investigators in this remote Tennessee role.

USZdružene države AmerikeTNTennesseeNa daljavoPolni delovni časJuniorDiploma ni potrebnaZahtevani Jezik: angleščinaSkladnost
Google Cloud Platform

Opis

  • Plan regulatory compliance for industry sponsors and network research sites.
  • Partner with regulatory leaders and investigators to maintain compliance.
  • Prepare for audits while meeting demanding deadlines.
  • Set up and maintain electronic regulatory document systems.
  • Maintain FDA- and GCP-required records for sites, studies, sponsors, and networks.
  • Check regulatory documents against local procedures for format and content.
  • Keep essential compliance records current.
  • Revise or develop informed consent forms.
  • Manage protocol, investigator brochure, and consent form changes in line with IRB policy and HIPAA.
  • Coordinate time-sensitive communications with sponsors and other stakeholders.
  • Prepare and submit documentation to IRBs across multiple trials.
  • Process protocol deviations that meet IRB reporting criteria.
  • Send urgent safety notices to the IRB.
  • Carry out additional duties as assigned.

Zahteve

  • High school diploma or equivalent is required.
  • An associate degree or higher is preferred.
  • Relevant experience may substitute for education.
  • At least one year of regulatory affairs experience in clinical research, pharmaceuticals, or a site management organization is strongly preferred.
  • Knowledge of medical terminology is strongly preferred.
  • Knowledge of FDA and other regulatory processes is strongly preferred.
  • Ability to manage a full study workload with limited supervision.
  • Knowledge of IRB policies and HIPAA compliance.
  • Familiarity with FDA and GCP documentation requirements.
  • Ability to meet strict deadlines and prepare for audits.

Ugodnosti

  • A Total Rewards package with benefits supporting physical, mental, and financial well-being.
  • Competitive compensation.
  • Annual bonuses or long-term incentives may be available.
  • Equity may be part of compensation.
  • McKesson employee benefits.

Sorodna delovna mesta

General Dynamics Information Technology

Senior AI Engineer and Architect

General Dynamics Information Technology
Sponzor vizuma H1BLogistikaSvetovanjeZdravstveno varstvo
USZdružene države Amerike
149.469 $ – 201.250 $ / leto
Na daljavoPolni delovni časSeniorVodjaZahtevani Jezik: angleščinaInženir strojnega učenjaInženir umetne inteligence
AWSAzureJavaOblakPorazdeljeni sistemiPythonRust

Lead AI, machine learning, and large language model architecture for General Dynamics Information Technology’s government, defense, and intelligence missions. Take solutions from proof of concept to production across complex operational settings.

Odpri