Edwards Lifesciences Senior Medical Writing Specialist, Scientific Communication - Critical Care (REMOTE USA) in Irvine, California
Edwards’ Critical Care technologies improve the lives of millions of patients each year. Through continuing collaboration with our clinicians, ongoing education, and our never-ending quest for innovation, Edwards continues to develop innovative hemodynamic management solutions that enable clinicians to provide better care to patients in the OR, ICU, and ED settings. The Medical Writer will be responsible for developing accurate and effective Clinical, Scientific, and Regulatory documents and presentations for external scientific conferences and meetings.
Research, create, and edit moderately complex scientific documents and presentations of clinical research based on input from the Clinical Team, Key Opinion Leaders (KOLs), and physician investigators
Write moderately complex clinical documents for regional regulatory submissions, including but not limited to: briefing documents, previous human experience summaries, investigator brochures, study protocols, informed consents, and interim and final clinical study reports for the assigned projects
Provide guidance to the Clinical team to develop the publication strategy and plans; create and may edit publication for all clinical studies in collaboration with KOLs
Conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients
Review draft publications for accuracy and continuity with previously published work and submitted regulatory documents
Project Lead for medical writing deliverables for assigned clinical studies. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues
Other incidental duties assigned by Leadership
Education and Experience:
A Bachelor's Degree in a related field and 5 years of experience of related scientific experience is required, OR, a Master's Degree and 3 years of scientific experience is required; or a PhD in a related field, with 1 e year of writing experience is required.
Experience as an author or contributor for peer-reviewed manuscripts is preferred
Experience as a medical writer for pharmaceutical, Contract Research Organization (CRO), or medical device clients is preferred
Ability to provide leadership and guidance; skilled in coaching and training techniques
Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)
Good editing and proofreading skills
Good written and verbal communication skills including negotiating and relationship management skills
Good problem-solving and critical thinking skills
Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
Moderate knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)
Moderate knowledge of statistics
Strict attention to detail
Ability to interact professionally with all organizational levels and functions where appropriate
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Adhere to all EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 15,000 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.