Senior Specialist, Medical Writing Job at Edwards Lifesciences in San Diego

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.

How you will make an impact :

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.

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 5 years of related experience working in medical affairs, clinical affairs and / or clinical science.

What else we look for (preferred) :

Advanced degree (Master’s or higher) in a related field.

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.

The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.

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

COVID Vaccination Requirement : 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.

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