Base: $130-160k; bonus/equity: eligible for bonus/...
Fully remote
Clinical and regulatory document creation
Us and eu submission expertise
Gcp, fda, ivdr/mdr, ema, ich guidelines
Danaher is seeking a Manager of Medical Writing to lead a team responsible for creating high-quality clinical and regulatory documents for diagnostics submissions in the US and EU. The role emphasizes mentoring, compliance with regulatory standards, and collaboration with cross-functional teams, all within a remote work environment
Job Summary
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.
Oversee the planning, writing, editing, and quality control of a wide range of clinical and regulatory documents, including technical documentation for CE-IVDR/MDR, summaries, and responses to notified body questions.
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: 85
Danaher is seeking a Manager of Medical Writing to lead a team responsible for creating high-quality clinical and regulatory documents for diagnostics submissions in the US and EU. The role emphasizes mentoring, compliance with regulatory standards, and collaboration with cross-functional teams, all within a remote work environment.
Salary
Base: $130-160k; Bonus/Equity: eligible for bonus/incentive pay; Benefits: comprehensive package including paid time off, medical/dental/vision insurance and 401(k)
Skills & Requirements
Must-have
Clinical and regulatory document creation
US and EU submission expertise
GCP, FDA, IVDR/MDR, EMA, ICH guidelines
Cross-functional team collaboration
Remote team leadership
Nice-to-have
Continuous process improvement
Leveraging AI in medical writing
Experience with MDs on team
Key Requirements
Bachelor's degree with 7+ years medical writing experience or Masters/Doctoral degree with 4+ years experience
3+ years direct leadership experience managing teams
Expert understanding of medical writing principles
Strong knowledge of US FDA and EU regulatory requirements