Principal Medical Writer
Location: Remote
Compensation: Salary
Staff Reviewed: Tue, Oct 29, 2024
This job expires in: 24 days
Job Summary
A company is looking for a Principal Medical Writer to lead the development of clinical and regulatory documents.
Key Responsibilities
- Lead the development of clinical study protocols, amendments, investigator's brochures, and other supporting documents
- Co-author clinical study reports (CSRs) and data summaries for regulatory submissions
- Collaborate with cross-functional teams to ensure compliance with ethical and regulatory standards
Required Qualifications
- Bachelor's degree in a scientific discipline; advanced degree (MS, PhD, MD, PharmD) is a plus
- A minimum of 6+ years of experience in pharmaceutical medical writing or related disciplines
- Proven track record of managing clinical study protocols and regulatory submission documents
- Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
- Experience with drug-drug and biologic-biologic combination products is a plus
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