Associate Director, Clinical and Technical Writing - Lexington
1 month ago

Job summary
Kiniksa Pharmaceuticals is seeking a highly motivated and experienced Associate Director of Clinical and Technical Writing to join our dynamic team.
Responsibilities
- Author review manage broad range documents including clinical study protocols investigator brochures CSRs regulatory submissions INDs NDAs BLAs briefing documents CTD modules technical documents CMC sections safety narratives lay summaries medical affairs materials scientific publications slide decks educational content ensure consistency messaging alignment strategic objectives lead contribute document planning meetings comment adjudication sessions submission timelines ensure documents meet internal standards comply ICH GCP FDA EMA global regulatory requirements maintain version control audit trails document management systems Veeva Vault SharePoint contribute development templates style guides SOPs mentor junior writers contractors needed support inspection readiness regulatory authority interactions partner Clinical Development Regulatory Affairs Biostatistics CMC Safety Medical Affairs teams
Job description
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