7+ years sponsor-level clinical regulatory medical writing experience
Ectd module 5 and module 2 writing for global maas
Experience managing in-house writers and external vendors
The role involves managing a team of medical writers while authoring critical content for regulatory submissions including protocols, IBs, and CSRs
Job Summary
The role involves managing a team of medical writers while authoring critical content for regulatory submissions including protocols, IBs, and CSRs.
Candidates will develop departmental strategy and infrastructure to ensure inspection-readiness and standardization across all medical writing activities.
The position offers a competitive base salary ranging from $212,000 to $291,500 along with short-term and long-term incentive programs.
Matching Summary
The role involves managing a team of medical writers while authoring critical content for regulatory submissions including protocols, IBs, and CSRs.
Salary
Base: $212,000.00 - $291,500.00 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
7+ years sponsor-level clinical regulatory medical writing experience
eCTD Module 5 and Module 2 writing for global MAAs
Experience managing in-house writers and external vendors
Authoring phase 1-4 protocols, IBs, CSRs, and master ICFs
Fluent American English proficiency required
Nice-to-have
Ph.D. in scientific or clinical discipline preferred
Ability to navigate interrelationships of various disciplines
Experience leading teams and mentoring junior writers
Solution-focused approach to complex problems
Knowledge of regulatory guidances for medical documents
Key Requirements
Bachelor's degree in scientific/clinical field (Ph.D. preferred)
Minimum 7 years of sponsor-level pharma/biotech experience
Native/bilingual fluent American English proficiency