Imagine how your ideas and expertise can change a patient’s life. We generate 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.

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 position, you are responsible for providing scientific expertise throughout the development and implementation of clinical evaluations and/or clinical studies for a dynamic portfolio of products across TMTT. The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.

• Act as primary contact for medical writing projects, working with other cross-functional Edwards departments to set and meet deliverable timelines.

• Develop routine, sustaining medical writing documents/deliverables for assigned project(s); propose approaches to developing moderately complex documents/deliverables

• Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders

• Conduct literature searches and reviews, including developing search strategy, managing associated documentation, and preparing literature summaries

• Provide input on other moderately complex cross-functional deliverables (e.g., risk management review, IFUs, SSED) using technical knowledge

• 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 a related field with 6 years of related experience working in medical affairs, clinical affairs and/or clinical science; OR

• Master's degree in a related field with 4 years of related experience working in medical affairs, clinical affairs and/or clinical science; OR

• Doctorate degree (PhD, MD, PharmD) with 2 years of related experience working in medical affairs, clinical affairs, and/or clinical science.

What else we look for (preferred):

• Familiarity with the cardiovascular therapeutic area—including, but not limited to, structural heart interventions, coronary interventions, heart failure—and current treatment landscape; familiarity with clinical research and/or clinical trial experience.

• Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.

• Familiarity with FDA PMA applications.

• Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations.

• Experienced with literature reviews and various publication databases including PubMed and Embase.

• Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.

• This position can be an onsite role based at Edwards Lifesciences’ corporate headquarters in Irvine, California.

Additional skills and general expectations:

• Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously

• Excellent oral and written communication skills

• Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge

• Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat

• Strong analytical, problem-solving, and scientific writing skills

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• 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