Immunic Therapeutics logo
Immunic Therapeutics

Immunic is a biotechnology company developing small molecule therapies for chronic inflammatory and autoimmune diseases

Senior Consultant – Medical Writing, Clinical Pharmacology

Content WriterContent WriterFull TimeRemoteSeniorTeam 51-200Since 2016Company SiteLinkedIn

Location

New York

Posted

1 day ago

Salary

Not specified

Seniority

Senior

Bachelor Degree1 yr expEnglish

Job Description

• Support Medical Writing activities in connection with a NDA submission • Collaborate with internal team members on NDA preparation by writing clinical modules (AMDE, DDI, FE/FA, BE, TQT, COC) • Support clinical pharmacology experts as lead medical writer • Provide project management for clinical pharmacology modules • Interact with non-clinical pharmacology experts, internal and external reviewers

Job Requirements

  • Solid experience in writing NDA / MAA / eCTD clinical modules and clinical pharmacology / Phase 1 study strictly required
  • Medical or science degree with substantial medical / regulatory writing experience in Biotech or Pharma
  • Native-level English proficiency
  • Strong understanding of drug development processes, regulatory interactions, and applicable global regulations (especially US FDA)
  • Proficient with relevant software tools, style guides, and document formatting standards
  • Excellent project management incl. leading cross-functional, international teams
  • Collaborative and proactive approach, and solution-focused mindset

Benefits

  • Flexible work arrangements

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