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Senior Medical Writer (M/F/D)
Tasks:
Support vaccine development programs (US Pacific Timezone)
Write, edit, and review scientific and regulatory documents (e.g., protocols, clinical study reports, informed consent forms, safety reports, abstracts, presentations)
Ensure compliance with GCP, GEP, ICMJE, and other relevant guidelines
Coordinate document processes, timelines, and content with cross-functional teams
Organize and moderate review cycles and stakeholder meetings
Conduct quality control (content, consistency, data verification, formatting)
Prepare for inspections and audits
Qualification:
Master’s degree or higher in Medicine, Pharmacy, or Life Sciences
7–10 years of experience in medical writing within pharma, biotech, or CRO
Proven experience supporting vaccine development, especially Phase 3 studies
Knowledge of immunology, vaccinology, and immunogenicity endpoints
Experience with global regulatory submissions (FDA, EMA, CHMP, PMDA)
Excellent English skills (written and spoken)
Proficiency in Office 365 and document management tools
Requirements:
Start: asap
Duration: 12 months+
Capacity: 4-5 days per week
Location: remote (west coast time zone)
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