Immunology Medical Writing Manager

Johnson & Johnson Innovative Medicine

Allschwil

Hybrid

CHF 140,000 - 180,000

Full time

9 days ago

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Job summary

Johnson & Johnson Innovative Medicine in Allschwil near Basel is seeking a Manager, Regulatory Medical Writing for Immunology. You will oversee the creation and review of clinical documents and lead a team in a collaborative, cross-functional environment.

You will ensure regulatory compliance, mentor staff, and drive high-quality submissions across programs, with opportunities to influence process improvements and industry standards.

Qualifications

  • Responsibilities include preparing and finalizing clinical documents.
  • Lead in a team environment with independence and take a lead role on projects.
  • Guide or train cross-functional team members on processes and best practices.
  • May lead project-level/submission/indication writing teams.
  • Proactively provide recommendations for departmental process improvements.
  • Lead writing group for a program as primary point of contact for medical writing activities.
  • Actively participate in medical writing and cross-functional meetings.
  • Maintain knowledge of industry, company, and regulatory guidelines.
  • Coach or mentor junior staff and oversee contractors as needed.
  • Represent Medical Writing in industry standards groups.

Responsibilities

  • Prepare and finalize all types of clinical documents.
  • Lead in a team environment with independence and take a lead role on assigned projects.
  • Guide or train cross-functional team members on processes and best practices.
  • May lead project-level writing teams and contribute to process improvements.
  • Coordinate with senior colleagues to strengthen cross-functional collaboration.

Skills

Analytics Insights
Business Writing
Clinical Research and Regulations
Clinical Trials Operations
Copy Editing
Cross-Functional Collaboration
Developing Others
Inclusive Leadership
Industry Analysis
Leadership
Medical Affairs
Medical Communications
Performance Measurement
Quality Validation
Standard Operating Procedure (SOP)
Tactical Planning
Team Management

Education

University/college degree; Masters or PhD preferred

Job description

Johnson & Johnson Innovative Medicine in Allschwil near Basel is seeking a Manager, Regulatory Medical Writing for Immunology. You will oversee the creation and review of clinical documents and lead a team in a collaborative, cross-functional environment.

You will ensure regulatory compliance, mentor staff, and drive high-quality submissions across programs, with opportunities to influence process improvements and industry standards.

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