Senior Medical Writer
Danaher Corporation
Summary
The Senior Medical Writer is responsible for the development of clinical evaluation reports (CERs) and post-market surveillance (PMS) reports in compliance with EU MDR and global regulatory standards. This role conducts systematic literature searches, appraises scientific evidence, and collaborates cross-functionally across Scientific Affairs, Clinical Research, Regulatory Affairs, Engineering, and Marketing to support product portfolio compliance and clinical communications.
Job description
This position reports to the Sr Director, Scientific Affairs & Research and is part of Medical Affairs located in Irvine, CA and will be an on-site role.
In this role, you will have the opportunity to:
- Lead the development, maintenance, and periodic updates of CERs and PMS evaluation summaries in accordance with EU MDR, MEDDEV 2.7/1 Rev. 4 and global regulatory guidance.
- Design, execute, and document systematic literature searches and screening strategies, while maintaining scientific reference libraries and ensure accurate citation and documentation of supporting evidence.
- Critically appraise scientific literature for quality, clinical relevance, and alignment with intended device claims.
- Interpret clinical study protocols, statistical analysis plans, and study results to incorporate into clinical evidence summaries.
- Prepare literature review reports, evidence summaries, state-of-the-art analyses, clinical data appraisals, and benefit-risk assessments.
- Monitor emerging scientific literature and technological developments relevant to Masimo products, therapeutic areas, and competitive technologies.
- Contribute to clinical study reports, white papers, conference abstracts, posters and scientific manuscripts for peer-reviewed journals.
The essential requirements of the job include:
- Demonstrated experience conducting systematic literature reviews and critical appraisals of scientific literature.
- Proven ability to interpret and summarize complex clinical and scientific information for technical and non-technical audiences.
- Experience managing scientific references and literature search platforms.
- Strong organizational skills and experience using reference management software.
It would be a plus if you also possess previous experience in:
- Direct experience authoring EU MDR-compliant CERs and PMS reports for medical devices.
- Working knowledge of EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 14155, and FDA clinical guidance documents.
- Proven track record of scientific publication in peer-reviewed journals.
Requirements
- Demonstrated experience conducting systematic literature reviews and critical appraisals of scientific literature.
- Proven ability to interpret and summarize complex clinical and scientific information for technical and non-technical audiences.
- Experience managing scientific references and literature search platforms.
- Strong organizational skills and experience using reference management software.
- Direct experience authoring EU MDR-compliant CERs and PMS reports for medical devices.
- Working knowledge of EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 14155, and FDA clinical guidance documents.
- Proven track record of scientific publication in peer-reviewed journals.
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Bonus pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.