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McKesson
McKesson
H1B vizasi homiysiKonsaltingLogistikaSog‘liqni saqlash

McKesson farmatsevtika mahsulotlarini tarqatish, tibbiy buyumlar va sog‘liqni saqlash xizmatlari yo‘nalishlarida faoliyat yurituvchi sog‘liqni saqlash kompaniyasidir. Uning faoliyati dorixonalar, klinikalar, sog‘liqni saqlash tizimlari va bemorlarga zarur davolash vositalaridan foydalanish imkonini berishga yordam beradi, shu bilan birga sog‘liqni saqlash operatsiyalarini samaraliroq tashkil etish va dori tanqisligiga barqaror javob qaytarishni qo‘llab-quvvatlaydi.

Kompaniya, shuningdek, ixtisoslashgan tibbiy amaliyotlar uchun dorixona boshqaruvi dasturiy ta’minoti, konsalting va texnologik yechimlarni ishlab chiqadi. McKesson biofarmatsevtika tashkilotlari bilan hamkorlik qiladi hamda dori vositalaridan foydalanish imkoniyati, davolanishga rioya qilish, tijoratlashtirish, ma’lumotlarga asoslangan tahlillar va real hayotdagi dalillarga yo‘naltirilgan xizmatlar orqali onkologiya va biofarmatsevtika amaliyotlarini qo‘llab-quvvatlaydi.

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Kompaniyadagi ish o‘rinlari

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.

USAmerika Qo‘shma ShtatlariTNTennessiMasofaviyTo‘liq stavkaJuniorDiplom talab qilinmaydiTalab Qilinadigan Til: inglizchaMuvofiqlik
Google Cloud Platform

Tavsif

  • 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.

Talablar

  • 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.

Imtiyozlar

  • 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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