Manager, Regulatory Medical Writing X-ta

Johnson & Johnson

Raritan, New Jersey, United States of America
Base: $117,000.00 - $201,250.00; bonus/equity: ann...
3d onsite
Regulatory medical writing
Clinical documents preparation
Cross-functional team leadership
Prepare and finalize all types of clinical documents, taking a lead role on assigned projects with respect to content and scientific strategy

Job Summary

  • Prepare and finalize all types of clinical documents, taking a lead role on assigned projects with respect to content and scientific strategy.
  • Guide or train cross-functional team members on processes and best practices, and potentially lead project-level/submission/indication writing teams.
  • Maintain knowledge of industry, company, and regulatory guidelines while coaching or mentoring more junior staff and overseeing the work of others.

Matching Summary

Prepare and finalize all types of clinical documents, taking a lead role on assigned projects with respect to content and scientific strategy.

Salary

Base: $117,000.00 - $201,250.00; Bonus/Equity: Annual performance bonus; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, savings plan, vacation, sick time, holiday pay, Work/Personal/Family Time

Skills & Requirements

Must-have

  • Regulatory Medical Writing
  • Clinical Documents Preparation
  • Cross-functional Team Leadership
  • Process Improvement Recommendations
  • ICH Guidelines Knowledge

Nice-to-have

  • Coaching and Mentoring Junior Staff
  • Industry Standards Working Groups
  • Learning Agility
  • Building Positive Relationships

Key Requirements

  • University/college degree required
  • 8 years pharmaceutical/scientific experience
  • 6 years medical writing experience
  • Multiple therapeutic areas experience preferred
  • English fluency required
  • Expert project/time management skills
  • Strong project/process leadership skills

Work Rights

Not specified

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