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1 день назад

Senior Strategic Medical Writer

96 500 - 183 500$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
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
Senior Strategic Medical Writer (Clinical and Regulatory Documentation): Leading and writing clinical and regulatory documents supporting the development of AbbVie drugs and devices with an accent on scientific communication, regulatory compliance, and cross-functional review. Focus on applying ICH and GCP guidelines, coordinating document quality control, resolving writing issues, and supporting inspection-ready responses.

Location: Remote, United States; listed address: North Chicago, Illinois

Salary: $96,500–$183,500 per year

Company

AbbVie discovers and delivers medicines and solutions for serious health issues across areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

  • Lead and prepare clinical and regulatory documents for drug and device development.
  • Coordinate cross-functional document review, approval, and quality control activities.
  • Organize and conduct review meetings with project stakeholders.
  • Maintain high-quality, compliant documentation and deliver projects within timelines.
  • Identify and resolve writing-process issues and escalate questions when appropriate.
  • Support leadership and R&D Quality Assurance with inquiries and inspection-ready responses.

Requirements

  • 4+ years of experience in the biopharmaceutical, biotech, life science, or healthcare-authority industry.
  • Bachelor’s degree or higher required; a scientific discipline is preferred.
  • Excellent written and oral communication skills and strong knowledge of medical and scientific terminology.
  • Experience writing and editing clinical and regulatory documents according to ICH, GCP, and other regulatory requirements.
  • Understanding of drug development, clinical research, study design, biostatistics, pharmacology, and regulatory requirements.
  • Ability to manage multiple projects, collaborate cross-functionally, and apply strong organizational and problem-solving skills.

Nice to have

  • Familiarity with CONSORT and PRISMA guidelines.
  • EU and US device-writing experience.

Culture & Benefits

  • Remote work arrangement.
  • Paid vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance for eligible employees.
  • 401(k) plan for eligible employees.
  • Eligibility for short-term incentive programs.

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