Bachelor's degree in scientific discipline required
The role involves serving as the primary author for complex clinical, nonclinical, and safety documents including protocols, IBs, and CSRs for regulatory submissions
Job Summary
The role involves serving as the primary author for complex clinical, nonclinical, and safety documents including protocols, IBs, and CSRs for regulatory submissions.
Candidates will manage a team of medical writers and external vendors while ensuring inspection-readiness and standardization across all programs.
The position offers a competitive base salary range of $164,000 to $225,500 along with short-term and long-term incentive programs.
Matching Summary
The role involves serving as the primary author for complex clinical, nonclinical, and safety documents including protocols, IBs, and CSRs for regulatory submissions.
Salary
Base: $164,000.00 - $225,500.00 USD annually; Bonus/Equity: Eligible for short-term and long-term incentive programs; Benefits: Comprehensive package including retirement savings and health benefits
Skills & Requirements
Must-have
5+ years sponsor-level medical writing experience
Native or fluent American English proficiency
Bachelor's degree in scientific discipline required
Nice-to-have
PhD preferred in scientific field
Familiarity with Veeva Vault preferred
Experience with pharmacovigilance documents
Key Requirements
Minimum 5 years sponsor-level pharma/biotech experience