Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.

The Role:

Immunovant is seeking a Principal Medical Writer or Senior Medical Writer to join our highly dynamic Regulatory team.

 Key Responsibilities: 

  • Formulate writing strategy for key clinical and regulatory documents and regulatory submissions; guides medical writing document preparation
  • Assume lead role for preparation of key clinical and regulatory documents and documents supporting regulatory submissions as well as responses to regulatory agencies/health authorities
  • Lead writing strategy providing expertise including organization, content, and timelines
  • Provide input and work with cross functional teams for study designs, Protocols, CSRs, sections of INDs, NDAs and MAAs
  • Manage deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content and adherence to regulatory requirements
  • Lead document submissions and meetings
  • Provide cross-functional guidance for document preparation, including US and EU regulatory guidance and requirements
  • Principal medical writer is seen as expert in medical writing and performs work independently with minimal supervision


Requirements:

  • Advanced degree
  • At least 7 years of experience writing clinical/regulatory documents for pharmaceutical, CRO, or biotechnology company required
  • Experience as lead writer for key documents including FDA and international regulatory submissions required
  • Clear understanding of clinical development, including phases, processes, and techniques used within a clinical development area from protocol design through regulatory submission
  • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (CTDs)

Work Environment:

  • Remote-based; Immunovant’s headquarters is located in New York City
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • May need to travel to NYC office or Durham office as needed

 

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