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McKesson
McKesson
H1B वीज़ा प्रायोजकपरामर्शलॉजिस्टिक्सस्वास्थ्य सेवा

McKesson एक स्वास्थ्य सेवा कंपनी है, जो फार्मास्युटिकल वितरण, चिकित्सा आपूर्ति और स्वास्थ्य सेवाओं के क्षेत्र में काम करती है। इसका कार्य फार्मेसियों, क्लीनिकों, स्वास्थ्य प्रणालियों और मरीजों को आवश्यक उपचार उपलब्ध कराने में मदद करता है, साथ ही अधिक कुशल स्वास्थ्य सेवा संचालन और दवाओं की कमी से निपटने के लिए मजबूत प्रतिक्रिया व्यवस्था का समर्थन करता है।

कंपनी विशेष चिकित्सा सेवाओं के लिए फार्मेसी प्रबंधन सॉफ्टवेयर, परामर्श और प्रौद्योगिकी समाधान भी विकसित करती है। McKesson बायोफार्मा संगठनों के साथ काम करती है और दवा की उपलब्धता, उपचार अनुपालन, व्यावसायीकरण, डेटा-आधारित अंतर्दृष्टि और वास्तविक दुनिया के प्रमाण पर केंद्रित सेवाओं के माध्यम से ऑन्कोलॉजी और बायोफार्मा प्रैक्टिस का समर्थन करती है।

LinkedIn
कंपनी की नौकरियाँ

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.

USसंयुक्त राज्यTNटेनेसीरिमोटपूर्णकालिकजूनियरडिग्री आवश्यक नहींआवश्यक भाषा: अंग्रेज़ीअनुपालन
Google Cloud Platform

विवरण

  • 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.

आवश्यकताएँ

  • 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.

लाभ

  • 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.

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