Senior Specialist, Medical Writing, Clinical Affairs

Imagine how your ideas and expertise can change a patient’s life. The Clinical Affairs team generates extensive clinical evidence to demonstrate the effectiveness and safety of our innovations, and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.This position is a remote-based role anywhere in the United States.How you will make an impact:The Senior Specialist, Medical Writing acts 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 complex medical writing documents/deliverables, and provide input on templates for assigned project(s)

Serve as the lead for 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

Act as Scientific Communications representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies

Lead and provide input on other complex cross-functional deliverables (e.g., risk management review, IFUs, SSED) utilizing technical knowledge

Provide leadership, training, and guidance and act as a mentor to less experienced medical writers

Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing

Other incidental duties assigned by Leadership

What you’ll need (Required)

Bachelor's Degree in a related field and 5 years of previous related experience in medical writing.

Alternatively, we will also consider:

Master's Degree in a related field and 3 years of previous related experience in medical writing.

What else we look for: (Strongly Preferred)In addition to meeting the basic requirements listed above, we strongly prefer candidates who possess these critical skills and background that will help us achieve our goals:

Medical writing experience specific to regulations within regulatory affairs scope, in medical device:

Experience writing FDA PMA applications, IDE Progress Reports and documents for PMA post approval requirements;

Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements

Cardiovascular medical device experience

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 $103,000 to $146,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.