Manager, Regulatory Medical Writing X-ta

Johnson & Johnson

High Wycombe, United Kingdom
Base: $117,000 to $201,250 (usd); bonus/equity: el...
3d onsite
Regulatory medical writing
Clinical documents preparation
Lead project strategy
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, potentially leading project-level/submission/indication writing teams.
  • Maintain knowledge of industry, company, and regulatory guidelines, and interact with senior cross-functional colleagues to strengthen coordination.

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 to $201,250 (USD); Bonus/Equity: Eligible for annual performance bonus; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, savings plan, paid time off

Skills & Requirements

Must-have

  • Regulatory Medical Writing
  • Clinical Documents Preparation
  • Lead Project Strategy
  • Cross-functional Team Leadership
  • ICH Guidelines Knowledge

Nice-to-have

  • Process Improvement Recommendations
  • Coaching Junior Staff
  • Industry Standards Representation
  • Learning Agility
  • Relationship Building

Key Requirements

  • 8+ years pharmaceutical/scientific experience
  • 6+ years medical writing experience
  • University/college degree required
  • Masters or PhD preferred
  • English fluency required

Work Rights

Not specified

Tailored Resume

Cover Letter