1 день назад
Senior Strategic Medical Writer
96 500 - 183 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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