Specialist, Medical Writing, Medical Affairs

2 weeks ago

Irvine, United States Edwards Lifesciences Full time

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

**How you will make an impact:**

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

**What you'll need (Required):**

+ Bachelor's Degree in related field with 3 years of previous related experience in medical writing OR

+ Master's Degree in related field with 1 year of previous related experience in medical writing

**What else we look for (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

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 $83,000 to $117,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

**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.

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.

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