Edwards Lifesciences Hiring for Specialist, Medical Writing (REMOTE, USA) TMTT at Irvine, CA Full Time

The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.

In this role, 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.

Essential Job Functions/Key Responsibilities:

• 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

Minimum Requirements :

Bachelor’s Degree with 3 years of medical writing experience; or MS/PhD or other advanced degree with relevant graduate research or post-doc experience

Preferred Qualifications :

• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
• MS or PhD degree or other advanced degree
• Medical Device, Pharma, or Biotech industry experience
• Experience in cardiology or interventional cardiology therapeutic areas
• Knowledge of FDA regulations or MedDev/EU MDR regulations
• Familiarity and/or experience with literature searches and reviews

Additional Talents and Expectations:

• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical 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 and understanding of policies, procedures and guidelines related to the development of scientific content
• Moderate knowledge of medical writing
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, 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

For Colorado Residents Only:

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.

The base pay range for this position is $95,000 to $111,000 .

Additional information can be found through the link below:

https://www.edwards.com/careers/benefits

#LI-REMOTE

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 or have a valid religious or medical exemption from being vaccinated. 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.

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