Medical Writer
$80,000–$130,000 year
On-site · Princeton, New Jersey, United States or Redmond, Washington, United States
Job Summary
Medical Writer will manage and oversee medical writing projects including clinical study protocols, synopses, and clinical study reports for regulatory submissions (FDA/ICH) and BLAs. They will write/edit high-quality regulatory documents (INDs, investigator brochures, informed consent review materials) ensuring templates and guidance are followed, and collaborate as a member of clinical trial teams while tracking milestones. Responsibilities include producing documents for regulatory authorities, supporting regulatory submissions, and writing/editing strategic documents as required; required skills include excellent scientific writing, strong communication, organizational and problem-solving abilities, knowledge of FDA/ICH guidelines, and experience with protocols, CSRs, ISE, ISS, and Clinical Overview. Preferred qualifications include knowledge of drug development/regulatory requirements and project management to maintain timelines. Salary range is $80,000-$130,000 per year; locations include Redmond, WA and Princeton, NJ with full-time on-site expectations.
Required Qualifications
- Master's degree in a life sciences discipline OR 3-4 years medical writing experience in pharma
- PhD with at least 1 year experience as a medical writer in pharma (preferred)
- Excellent writing and communication skills
- Interpersonal, organizational and problem-solving skills in a matrix environment
- Knowledge of FDA and ICH guidelines
- Skilled in clinical data interpretation
- Proven experience writing protocols, CSRs, ISE, ISS, Clinical Overview and other major documents
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.