Edwards Lifesciences is hiring : Senior Specialist, Medical Writing in Washington

Join to apply for the Senior Specialist, Medical Writing role at Edwards Lifesciences .

As part of our Clinical Affairs team, you will support the development of regulatory and clinical documents across a dynamic portfolio in the Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit. You will work with principal investigators, medical professionals, patient advocacy groups, and regulatory authorities to generate evidence that optimizes patient outcomes and demonstrates safety and effectiveness of our innovations.

How you will make an impact :

As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science / Medical Writing supports regulatory and clinical documents for a portfolio of products across TMTT.

Perform and maintain systematic literature searches, develop search terms, extract relevant clinical data, and write clear summaries to support 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 feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge.

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

Assist in implementing continuous process improvements related to medical writing.

Other incidental duties.

What you’ll need (required) :

Bachelor’s Degree in a related field with 5 years of related experience in medical affairs, clinical affairs, and / or clinical science.

What else we look for (preferred) :

Preferred Hybrid On Site in Irvine, CA

Advanced degree (Master’s, PhD, PharmD)

Experience with literature reviews and publication databases (PubMed, Embase)

Familiarity with cardiovascular therapeutic area, clinical research, and / or clinical trial experience

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

Familiarity with FDA PMA applications

Knowledge of scientific research methodology, device development, GCP, ICH guidelines, and US / EU regulations

Experience working in cross-functional, collaborative environments with R&D, regulatory, physicians, statisticians, and support personnel

Onsite role at Edwards Lifesciences’ corporate headquarters in Irvine, California (location may be onsite)

Additional skills and general expectations :

Ability to work independently, prioritize, and manage multiple tasks

Excellent oral and written communication skills

Maintain current product knowledge including clinical literature and therapeutic / product operation knowledge

Advanced skills in MS PowerPoint, Word, Excel, EndNote, and Adobe Acrobat

Strong analytical, problem-solving, and scientific writing skills

Attention to detail; ability to interact professionally at all organizational levels

Ability to work in a team environment and build productive internal / external relationships

Commitment to putting patients first

Compensation and benefits : Aligning our business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address diverse employee needs. For California, the base pay range is $106,000 to $149,000 (highly experienced). The final offer depends on qualifications, education, and prior experience. Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement : All patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, you will be required to provide proof of vaccination unless you request and are granted a medical or religious accommodation. This requirement does not apply where prohibited by law.

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