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8 часов назад

Regulatory and Start Up Specialist - Norway

Формат работы
remote (только Norway)
Тип работы
fulltime
Английский
b2
Страна
Norway
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
Regulatory and Start Up Specialist - Norway (Clinical Research): Coordinating country-level site activation and regulatory activities for clinical studies with an accent on Norwegian submissions, document quality, and compliance with local and international regulations. Focus on tracking regulatory and ethics approvals, maintaining study systems and timelines, and providing local expertise to project teams.

Location: Home-based in Norway; Oslo, Norway

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Act as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
  • Perform country-level start-up and site activation activities in line with applicable regulations, SOPs, work instructions, and project requirements.
  • Prepare, review, distribute, and quality-control site regulatory and contractual documents.
  • Track regulatory, ethics, informed consent, and Investigator Pack document approvals and execution against project timelines.
  • Maintain study databases, tracking tools, and internal systems with accurate project information.
  • Support planning, monitor site performance, and provide local expertise and contingency planning to project teams.

Requirements

  • Fluency in Norwegian is required.
  • Local submissions experience in Norway is required.
  • Experience with regulatory documents, ethics submissions, informed consent forms, and Investigator Packs.
  • Ability to follow SOPs and work instructions while maintaining document quality and project timelines.
  • Experience coordinating with investigative sites, sponsors, and cross-functional clinical research teams.

Culture & Benefits

  • Home-based work arrangement.
  • Work within a global clinical research and healthcare intelligence organization.
  • Exposure to innovative medical treatment development and patient outcome improvement.

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