Scientist II, Medical Writing
Core
Transform complex scientific and clinical data into clear, accurate, and high-quality regulatory and non-regulatory documentation for pharmaceutical, biotechnology, and medical device clients.
Role type
Medical Writer (Regulatory Sciences)
Builds
Regulatory documents (CTD Module 2 summaries, Clinical Overviews, CSRs, protocols, manuscripts, Investigator Brochures) for global pharma/biotech clients
Domain
Life Sciences / Regulatory Affairs / Medical Writing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial data interpretation, regulatory document authoring, editing and proofreading, version control management, project timeline adherence
Preferred skills
Understanding of clinical trial methodologies, ability to work under pressure
Technologies
eCTD
Responsibilities
Write and edit clinical regulatory documents (CTD Module 2 summaries, CSRs, protocols, etc.), ensure documents meet regulatory and quality standards, incorporate reviewer feedback, manage version control, deliver projects on-time and on-budget
Seniority
Mid-level IC (2-3 years experience)
