Job description

The Senior Technical Writer will be a critical member of the Edwards Quality Biology Laboratories, assisting the toxicology team with developing non-clinical documentation to support regulatory submissions for Edwards’ devices.

Role is remote, open to US based candidates. Occasional travel (once a quarter) to the Irvine, CA Corporate Campus location may be required.

Key Role Responsibilities:

• Provide technical writing expertise to create biological safety assessments based upon Good Laboratory Practices (GLP) protocols and reports, technical summaries, clinical instructions for use (IFUs) and chemical characterization reports for domestic and international regulatory submissions.
• Collaborate with stakeholders (e.g., technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes
• Maintain documentation in a standard format following established guidelines
• Review documents for style, clarity, grammar, and punctuation
• Identify and correct inconsistencies of thought, development, or organization and confer with authors to recommend an appropriate adjustment in documents and procedures
• Recommend improvements to current documentation practices and propose recommended changes
• May lead special projects (e.g. implementation of new documentation procedures)
• Other duties assigned by Leadership; Provide guidance and training to lower level employees

Education and Experience Requirements

Bachelor's Degree in related field, plus minimum of 5 years relative technical writing experience required (or Masters Degree plus minimum of 4 years experience).

Experience as a technical writer in the medical device or biotechnology industry (e.g., Quality Assurance, Regulatory) highly preferred

Additional Skills and Expectations:

• Advanced knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation
• Advanced editing and proofreading skills
• Full knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports)
• Advanced use of Microsoft Office Suite including Word, Excel, PowerPoint, and Acrobat
• Professional communication, interpersonal and relationship management skills
• Ability to manage competing priorities in a fast paced environment
• Thrives in a collaborative team environment, including inter-departmental teams and working as a key contact representing the organization on projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $76,000 to $108,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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