About the role

  • Lead preparation of clinical trial documents including protocol synopses, full protocols, and clinical study reports
  • Lead development of clinical and nonclinical documents submitted to regulatory authorities including investigator brochures, study protocols, model informed consents, interim and final CSRs, module 2 documents, and regulatory briefing books
  • Produce complex clinical or scientific documents and sections of INDs, NDAs, CTDs, and dossiers
  • Position information and data for presentation of clinical, pharmacokinetic, pharmacodynamic and statistical written materials; lead compilation of CSR appendices and clinical narratives
  • Provide detailed medical editing review (copy editing and content review) of draft and final documents
  • Ensure document content and style adheres to EMEA/FDA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines
  • Perform literature searches and reviews to obtain background information and provide literature references
  • Develop medical writing SOPs and style guidelines
  • Manage timelines for document preparation, create detailed processes, set up kick off and comment resolution meetings, and own workflows in Veeva
  • Perform other duties as assigned

Requirements

  • Bachelor’s degree or equivalent in a scientific discipline, advanced degree preferred
  • At least 7 years’ experience in regulatory writing and knowledge of preparing documents to ICH standards
  • Prior experience within the Pharmaceutical or CRO industry
  • Strong scientific and/or medical writing knowledge preferred
  • Ability to lead writing and compilation of clinical documents
  • Ability to influence and drive key decisions and stakeholders within a project team
  • Strong understanding of pharmaceutical industry procedures and regulations
  • Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance
  • Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance.
  • Best-in-class benefits for our team of SpringWorkers (see Benefits page).

Job title

Senior Medical Writer

Job type

Experience level

Senior

Salary

$114,000 - $150,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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