Scientific Writer
Science Industry
1 hour ago
Full-time
Remote
United States
$109,000 - $179,000 USD yearly
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We are seeking a Scientific Writer to join our Scientific Writing team, translating complex nonclinical PK/PD and pharmacology data into clear regulatory narratives that support critical drug development and regulatory decisions. In this role, you will serve as the primary Scientific Writing partner to Translational Pharmacokinetics & Pharmacodynamics and Nonclinical Pharmacology, helping teams communicate exposure-response relationships, dose selection rationale, and mechanistic insights across development programs.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: [Insert location]
- Work model/flexibility: [Insert work model]
Discover your role:
- Independently author nonclinical PK/PD study reports, eCTD summaries, and Investigator's Brochure content
- Lead development of integrated regulatory narratives that synthesize PK, PD, and mechanistic data
- Collaborate with scientists and cross-functional teams to interpret data and ensure consistent PK/PD messaging across programs
- Coordinate data inputs, reviews, timelines, and stakeholder communications to support high-quality, on-time deliverables
- Drive process improvements through authoring guidance, workflow optimization, and AI-enabled writing and quality-control solutions
- Serve as the scientific writing lead for assigned programs, providing strategic document planning and cross-functional coordination
This role requires:
- Bachelor's degree in a life sciences discipline; advanced degree (MS or PhD) preferred
- Relevant combination of scientific and regulatory writing experience supporting nonclinical development programs
- Experience working with laboratory-generated pharmacology, PK, and/or PD data on a nonclinical drug development team
- Knowledge of drug development, eCTD guidelines, and ICH, FDA, and EMA/CHMP nonclinical requirements, including eCTD Modules 2.4, 2.6, and 4
- Experience using document authoring, review, and collaboration tools in a regulated environment