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Senior Medical Writer

Posted 13 days agoViewed

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💎 Seniority level: Senior, 4+ years

💸 Salary: 140000.0 - 157000.0 USD per year

🔍 Industry: Biotech/pharmaceutical

🏢 Company: Spyre Therapeutics👥 1-50💰 $180,000,000 Post-IPO Equity about 1 year agoBiotechnologyTherapeutics

⏳ Experience: 4+ years

Requirements:
  • 4+ years of regulatory medical writing experience within the biotech/pharmaceutical industry
  • Proven track record of successfully managing clinical study protocols, their amendments, study reports, investigator’s brochures, and other key clinical and regulatory submission documents
  • Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
Responsibilities:
  • Author clinical study protocols, amendments, IBs, and other supporting documents
  • Author CSRs and data summaries for INDs, CTAs, BLAs, and MAAs
  • Identify risks and contribute to risk mitigation or contingency planning for submission activities
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