Description
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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey!
Roles and Responsibilities
In this role in TMTT Medical Affairs, you will act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines.
- Develop moderately complex medical writing documents/ deliverables for assigned project(s).
- Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders.
- Conduct literature searches and reviews including developing search strategy, manage associated documentation, and prepare literature summaries.
- Provide input on other moderately complex cross-functional deliverables (e.g., risk management review, IFUs, SSED) utilizing technical knowledge.
- Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing.
- Other incidental duties.
Education (Required)
- Bachelor's Degree in related field with 3 years of previous related experience in medical writing.
Education and Experience (Preferred)
- MS or PhD degree or other advanced degree.
- Medical Device, Pharma, or Biotech industry experience.
- Experience in cardiology or interventional cardiology therapeutic areas.
- Familiarity and/or experience with literature searches and reviews.
- Experience analyzing and interpreting clinical data
- Knowledge of FDA regulations or MedDev/EU MDR regulations.
- Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel.
- Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques.
