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2 дня назад

Senior QC Editor (Pharmaceutical)

Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
c1
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
Senior QC Editor (Pharmaceutical): Reviewing and copyediting clinical and regulatory documents while verifying factual accuracy against cited sources, with an accent on data integrity, regulatory compliance, and document quality. Focus on resolving discrepant findings, improving QC processes, training colleagues, and coordinating multiple high-priority assignments under tight deadlines.

Location: United States; remote work is supported, with hybrid work encouraged for hires living within a reasonably short commute of an office.

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

  • Perform detailed QC reviews of clinical and regulatory documents, tables, publications, reports, literature summaries, and submission sections.
  • Verify factual statements against cited post-text sources and interpret clinical data and literature when needed.
  • Copyedit documents for grammar, spelling, punctuation, style, formatting, functionality, and presentation.
  • Lead the resolution, documentation, implementation checks, and archiving of discrepant findings.
  • Manage multiple projects and deadlines while contributing to QC initiatives, process improvements, policies, and procedures.
  • Train and mentor new hires and junior colleagues, provide QC training to medical writers, and represent QC on cross-functional teams.

Requirements

  • At least 3 years of QC or editing experience in the pharmaceutical industry.
  • Bachelor’s degree in a relevant field.
  • Strong copyediting, data integrity review, accuracy, problem-solving, time management, and attention-to-detail skills.
  • Knowledge of FDA and EU requirements, ICH regulations, ISO standards, and the AMA Manual of Style.
  • Fluent English required, with excellent written and oral communication skills.
  • Expertise with Microsoft Office and Adobe/PDF software; ability to work independently on multiple deadline-driven assignments.

Nice to have

  • Background in pharmaceutical or biotech organizations.
  • Experience supporting regulatory documents and clinical or medical writing teams.

Culture & Benefits

  • Remote work is supported, with hybrid collaboration encouraged for employees located near an office.
  • Inclusive workplace focused on diversity, equity, and inclusion.
  • Employees are encouraged to contribute innovative, collaborative, and entrepreneurial ideas.
  • Applications are reviewed personally by the recruitment team without AI screening tools.

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