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обновлено 4 дня назад

Medical Writer / Clinical Document Author

50 - 80$
Формат работы
remote (Global)
Тип работы
fulltime
Грейд
senior
Английский
b2
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
Medical Writer / Clinical Document Author (Regulatory Medical Writing): Developing, reviewing, and evaluating clinical and regulatory documents with an accent on Clinical Study Reports, safety documentation, ICH compliance, and scientific accuracy. Focus on interpreting clinical protocols, verifying source data and TFLs, assessing eCTD requirements, and supporting AI-assisted documentation evaluation.

Location: Remote

Pay: $50–$80 per hour

Company

hirify.global provides consulting services.

What you will do

  • Author and review Clinical Study Reports and other regulatory documents.
  • Interpret clinical protocols and apply ICH guidelines to documentation.
  • Verify scientific accuracy using source data, Tables, Figures, Listings, and study documentation.
  • Review safety documents, including DSURs and PSURs/PBRERs.
  • Provide structured feedback and collaborate with cross-functional teams.
  • Support AI-assisted documentation evaluation and quality improvement initiatives.

Requirements

  • 5+ years of regulatory medical writing experience in a sponsor, CRO, or consulting environment.
  • Experience authoring Clinical Study Reports and regulatory documentation.
  • Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
  • Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field, such as MD, PharmD, PhD, or MSc.
  • Strong written communication and collaboration skills.

Nice to have

  • Experience in oncology and haematology.

Culture & Benefits

  • Remote contractor engagement.
  • Hourly compensation of $50–$80.

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