The Technical Writer will be a critical member of the Edwards Quality Biology Laboratories. They will primarily assist the toxicology team with developing non-clinical documentation to support regulatory submissions for Edwards’ devices.
**Responsibilities for this position include:**
+ Provide technical writing support for the generation of 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.
+ Generate and maintain documentation in a standard template format following established guidelines.
+ Generate formatted tabular data summaries using chemical characterization reports to facilitate the development of toxicological risk assessments. This will include interface with members of the chemistry group to ensure clarity of data presentation.
+ Support the maintenance of a library of risk summaries to support medical device risk evaluations.
+ Perform quality control (QC) checks of draft documents to ensure the accuracy of the data and resulting subsequent conclusions.
+ Support the archiving of completed reports.
+ Review documents for style, clarity, grammar, and punctuation.
+ Interface with engineers, regulatory affairs, project teams, lab personnel and management to develop an understanding of the devices.
+ Ensure compliance with department and company procedures.
The Technical Writer requires three (3) or more years of technical writing experience. Prior experience in the biotechnology-medical device industry is preferred.
**Additional qualifications include:**
+ Excellent oral and written communication skills, along with exceptional organization, editing and proofreading skills.
+ Demonstrated ability to master technical content through interaction with subject matter experts.
+ Ability to produce documentation that combines creativity with clarity and precision while meeting tight deadlines.
+ Advanced knowledge and expertise with Windows operating systems and specific documentation tools (MS Word, Excel, PowerPoint, Publisher, Adobe, etc.) used in the department.
+ Familiarity with Good Laboratory Practices (GLP) guidelines, International Standard for Organization (ISO) 10993-1, and quality system requirements for the medical device industry.
+ Must be able to work in a team environment
+ Bachelor’s degree in science related field (Biology, Chemistry etc) preferred.
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.
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. Edwards is an Equal
Opportunity/Affirmative Action employer including protected Veterans and
individuals with disabilities.
Title: Technical Writer (Toxicology)
Location: USA-USA-California – Irvine
Job Number: 020345