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- Remote, United States
- Remote
- Full-time · Manager
- $181K–$235K per year
- 7+ years
Lead medical writing activities, authoring and reviewing regulatory and scientific documents for the company’s pipeline.
Compensation
$181,000—$235,000 USD
Responsibilities
- Own day‑to‑day execution of medical writing activities
- Author, coordinate, and review key clinical and regulatory documents
- Contribute to shaping the strategy for submission narratives
- Represent Medical Writing in cross‑functional forums
- Collaborate with Clinical Development, Regulatory Affairs, and other teams
Requirements
- Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or related discipline
- Nice to have: Deep scientific expertise in immunology, inflammation, or autoimmune disease
- Nice to have: Experience with FDA and EMA regulatory requirements
- Nice to have: Knowledge of ICH CTD format