Senior Specialist, Medical Writing

Edwards Lifesciences

Senior Specialist in Medical Writing responsible for regulatory and clinical documents. Collaborating with cross-functional teams to enhance patient outcomes in cardiovascular therapies.

Posted 5/13/2026full-timeIrvine • Arizona, California, Colorado, Washington • 🇺🇸 United StatesSenior💰 $106,000 - $149,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products
Perform and maintain systematic literature searches
Develop routine, sustaining medical writing documents/deliverables
Review and provide thoughtful feedback on cross-functional deliverables
Serve as the primary contact, negotiating deliverables
Assist in the implementation of continuous process improvements as it relates to medical writing

Requirements

What you’ll need

Bachelor's Degree in a related field
5 years of related experience working in medical affairs, clinical affairs and/or clinical science or equivalent work experience
Experience with literature reviews and various publication databases including PubMed and Embase
Familiarity with the cardiovascular therapeutic area
Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations
Familiarity with FDA PMA applications
Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global regulations
Experience working in a cross functional, collaborative environment

Benefits

Comp & perks

Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingliterature reviewsscientific research methodologydevice development processGCPICH guidelinesregulatory documentsclinical documentscross-functional deliverablescontinuous process improvements

Soft Skills

negotiationcollaborationfeedbackcommunicationorganizational skills