Manager, Medical Writing

Danaher UK

Remote
Base: $130-160k; bonus/equity: eligible for bonus/...
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Lead and develop medical writing team
Oversee clinical and regulatory documents
Ensure scientific accuracy and regulatory compliance
** Danaher UK is seeking a Manager for Medical Writing to lead a remote team responsible for creating clinical and regulatory documents for the diagnostics sector. The ideal candidate should possess substantial experience in medical writing, particularly for US and EU submissions, along with demonstrated leadership skills. **

Job Summary

  • The Manager, Medical Writing, is responsible for leading and developing the medical writing team for Danaher Diagnostics, overseeing the creation of high-quality clinical and regulatory documents for submission in the US and EU markets.
  • You will manage a team of experienced medical writers, many with clinical backgrounds (MDs), ensuring scientific accuracy, regulatory compliance, and timely delivery of essential documentation to support clinical studies and product registrations.
  • Implement continuous improvement to medical writing processes, templates, and standards to improve efficiency, consistency, and quality within the team, leading with DBS and leveraging AI in accordance with company policies.

Matching Summary

Match Score: 75

** Danaher UK is seeking a Manager for Medical Writing to lead a remote team responsible for creating clinical and regulatory documents for the diagnostics sector. The ideal candidate should possess substantial experience in medical writing, particularly for US and EU submissions, along with demonstrated leadership skills. **

Salary

Base: $130-160k; Bonus/Equity: eligible for bonus/incentive pay; Benefits: comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k)

Skills & Requirements

Must-have

  • Lead and develop medical writing team
  • Oversee clinical and regulatory documents
  • Ensure scientific accuracy and regulatory compliance
  • Manage medical writing timelines and resources
  • Subject matter expert on medical writing best practices

Nice-to-have

  • Harnessing Danaher's system of continuous improvement
  • Leveraging AI in accordance with company policies
  • Culture of belonging where viewpoint matters

Key Requirements

  • Bachelor's degree with 7+ years experience or Masters/Doctoral degree with 4+ years experience
  • 3+ years direct leadership experience managing a team
  • Expert understanding of medical writing principles
  • Strong knowledge of US FDA and EU regulatory requirements
  • Experience working with clinical study data

Work Rights

Not specified

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