Sr Scientific Writing Specialist
Core
Draft and manage reviews of Clinical Bioanalysis and Clinical Pharmacology submission documents across multiple therapeutic areas and clinical development phases.
Role type
Senior Scientific Writing Specialist (Clinical Regulatory)
Builds
Regulatory submission documents for life-changing medicines
Domain
Biopharmaceuticals / Clinical Development
Required skills
Scientific writing, document review, meeting leadership, project management, data consistency review, template maintenance, English fluency, life science background
Preferred skills
Digital content generation tools, eCTD knowledge, protein therapeutics, gene therapy
Technologies
Microsoft Word, Excel, Adobe, PerfectIt, AI tools
Responsibilities
Independently draft and manage review of reports and summaries, Lead Kickoff/Author/Comment Reconciliation meetings, Attend cross-functional program meetings, Manage multiple projects and timelines, Review data outputs for consistency, Participate in revision of document templates
Seniority
Senior, hands-on IC