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7 дней назад

Document Coordinator, Product Integrity/Toxicology

79 000 - 97 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Document Coordinator, Product Integrity/Toxicology (Document Control/Regulatory Submissions): Managing controlled internal documentation and preparing records for domestic and international regulatory submissions with an accent on document accuracy, version control, and audit readiness. Focus on indexing nonclinical study materials, updating databases and spreadsheets, and maintaining compliant electronic and hard-copy records.

Location: Durham, North Carolina, United States; onsite

Salary: $79,000–$97,000 USD annually

Company

hirify.global Labs develops and markets nicotine products with a focus on transitioning adult smokers away from combustible cigarettes, product quality, research, and reducing underage use.

What you will do

  • Control, file, store, track, and process internal documents in electronic and hard-copy formats.
  • Ensure document updates and new releases are completed accurately and on time.
  • Prepare and provide document copies for domestic and international regulatory submissions.
  • Support internal and external audits by maintaining complete and appropriate records.
  • Update controlled-document folders, databases, and spreadsheets.
  • Index and inventory study setup information, spreadsheets, nonclinical protocols, and nonclinical reports.

Requirements

  • 1–3 years of related experience in a regulated environment.
  • Strong attention to detail and accurate information management.
  • Excellent verbal and written communication skills.
  • Ability to navigate online systems, conduct searches, and complete digital forms.
  • Ability to collaborate with people from diverse backgrounds.
  • Experience with Microsoft Office, G-Suite, and electronic databases; authorization to work in the United States is required.

Nice to have

  • Bachelor’s degree in science, business, or a related field, or relevant work experience.
  • VEEVA Vault experience.

Culture & Benefits

  • Career development support and opportunities to grow.
  • Equity and performance-based bonuses.
  • Cell phone subsidy, commuter benefits, and product discounts.
  • Medical, dental, vision, disability, and life insurance.
  • Family support, wellness, legal, and employee assistance programs.
  • 401(k) plan with company matching.

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