The role involves contributing to the development of complex clinical, nonclinical, and safety documents for regulatory submissions while building critical department infrastructure
Job Summary
The role involves contributing to the development of complex clinical, nonclinical, and safety documents for regulatory submissions while building critical department infrastructure.
Candidates will serve as primary authors for phase 1-4 protocols, IBs, CSRs, and eCTD modules required for INDs and BLAs.
The position offers a competitive annual base salary range of $164,000.00 - $225,500.00 USD along with short-term and long-term incentive programs.
Matching Summary
The role involves contributing to the development of complex clinical, nonclinical, and safety documents for regulatory submissions while building critical department infrastructure.
Salary
Base: $164,000.00 - $225,500.00 USD; 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/bilingual American English proficiency
eCTD Module 2 and Module 5 writing expertise
Experience with INDs and BLA submissions
Ability to manage in-house writers and vendors
Nice-to-have
Familiarity with Veeva Vault platform
Knowledge of pharmacovigilance documents
PhD in scientific or clinical discipline
CRO experience considered
Strong preference for East Coast location
Key Requirements
Bachelor's degree required; PhD preferred
Minimum 5 years related pharma/biotech experience
Fluent American English proficiency
US work authorization (implied by US salary range)