Manager, Medical Writing, Immunology Job at Johnson & Johnson, Spring House, PA

  • Johnson & Johnson
  • Spring House, PA

Job Description

Manager of medical writing for immunology programs within Johnson & Johnson's Innovative Medicine division. This leadership role involves preparing regulatory documents, managing writing teams, mentoring staff, and ensuring compliance with industry and regulatory standards.

Responsibilities

  • Prepare and finalize clinical regulatory documents for immunology programs
  • Lead medical writing teams, set objectives, and manage direct reports
  • Coach and mentor junior medical writers and review deliverables
  • Serve as primary point of contact for medical writing activities on assigned programs
  • Participate in cross-functional meetings and recommend process improvements

Requirements

  • University or college degree; Master's or PhD preferred
  • At least 8 years of pharmaceutical or scientific experience
  • At least 6 years of medical writing experience
  • 2 years of people management experience preferred
  • Strong knowledge of regulatory guidance documents and ICH requirements
  • Excellent written and oral communication abilities
  • Expert project management and process leadership skills

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