Senior Medical Writer

MedDeviceJobs; Irvine (CA); On-site; USD 130,000 - 150,000; Full time

Job summary

Masimo, a Danaher operating company, in Irvine, CA, seeks a Senior Medical Writer to develop CERs and PMS reports for EU MDR and global regulatory standards. You will design literature searches, appraise evidence, and collaborate across Scientific Affairs, Clinical Research, Regulatory Affairs, Engineering and Marketing.

You will interpret study protocols and results to support clinical communications, contribute to clinical study reports and peer-reviewed manuscripts, monitor emerging

Qualifications

• Experience conducting systematic literature reviews and critical appraisals of scientific literature.
• Ability to interpret and summarize complex clinical information for technical and non-technical audiences.
• Experience managing scientific references and literature search platforms.
• Strong organizational skills and experience using reference management software.

Responsibilities

• Lead development, maintenance, and updates of CERs and PMS reports per EU MDR and MEDDEV guidance.
• Design, execute, and document systematic literature searches and screening strategies.
• Critically appraise literature for quality, relevance, and alignment with device claims.
• Interpret clinical study protocols and results for clinical evidence summaries.
• Prepare literature review reports, evidence summaries, and state-of-the-art analyses.
• Monitor emerging literature and developments relevant to Masimo products.

Skills

Systematic literature reviews

Interpret complex clinical information

Literature appraisal

Reference management software

Tools

Reference management software

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Masimo, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others.

Learn about the Danaher Business System which makes everything possible.

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.

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

Masimo , a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

The annual salary range for this role is $130,000-$150,000 This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus pay.

Bonus / Incentive Pay

10% of annual base salary

This job is also eligible for bonus / incentive pay. This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].