Full time
Req-39103
1 month ago
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.
As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents 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.
This position is an onsite role based at Edwards Lifesciences’ corporate headquarters in Irvine, California.
How you will make an impact:
Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports
Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables
Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge
Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders
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):
Experienced with literature reviews and various publication databases including PubMed and Embase.
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.
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
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 (CA), the base pay range for this position is $106,000 to $149,000 (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 committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable regulation.
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