Apex Systems

Toxicology Writer

Our client is seeking a remote Toxicology Writer!

Summary/Objectives

The Technical Writer is responsible for writing technical summaries and related submission components intended for filing with international health authorities, as well to support numerous other document-development projects like client protocols, reports, SOPs, and various GMP documentation. 

Essential Functions

  • Distills technical information from multiple sources into concise and well-crafted written deliverables that are aligned with our highest standards of quality and meet both client and health authority expectations.
  • Using source documentation provided from internal sources, the client and contracted CRO’s, write sections of regulatory documents and other related submissions
  • Independently read and digest technical documentation pertaining to the development, manufacture, and testing of various and complex products, asking appropriate questions and conducting independent research as needed to enable the writing of summary sections for regulatory submission
  • Mine through technical documents for relevant data, synthesize information, develop narratives, and construct flow diagrams, tables, and figures as needed to convey technical information
  • Organize the flow of information through documents and write clear and concise technical content using well-constructed sentence and paragraph structure
  • Keep abreast of pertinent health authority guidance, regulations, and trends
  • Ensure high quality deliverables are generated at appropriate stages and under agreed-upon timelines
  • Review and provide feedback on the work of colleagues; contribute your technical expertise to the team and be open to learning/cross-training in other technical areas; lead and develop other team members as needed
  • Reviews/approves batch records, change controls, complaints and investigations to ensure compliance with cGMP’s, ICH guidelines and other regulatory requirements
  • Develops/Authors SOPs
  • Supports submittal of regulatory filings and responses to agency inquires
  • Facilitates Interdepartmental and Intradepartmental collaboration to meet regulatory timelines
  • Reviews specifications for starting materials and final product
  • Other duties as assigned

Knowledge/Skills/Abilities

  • BA/BS or MS in Toxicology or related. 
  • 5+ years of toxicology writing experience within a FDA regulated industry
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Made with ♥ in Philly.