Senior Specialist, Medical Writing Job at Edwards Lifesciences in Boston

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

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 pursuing an innovative portfolio of technologies to address unmet clinical needs and help patients live longer and healthier lives.

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, develop search terms and criteria, extract relevant clinical data, and write clear and concise summaries 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 and timelines, and 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)

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

Experience with literature reviews and various publication databases including PubMed and Embase.

Familiarity with the cardiovascular therapeutic area—including 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 with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.

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

Additional skills and general expectations

Ability to work independently, prioritize and manage multiple tasks simultaneously.

Excellent oral and written communication skills.

Maintaining current, in-depth product knowledge including current developments and clinical literature review, as well as therapeutic and product operation knowledge.

Advanced working knowledge of MS PowerPoint, Word, 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 and work in a cross-functional team.

Commitment to putting patients first as part of a medical device-focused role.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs. 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 an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement : Edwards is committed to protecting our patients and healthcare providers. All patient-facing and in-hospital positions require COVID-19 vaccination unless an accommodation is granted under applicable law.

Job details

Seniority level : Not Applicable

Employment type : Full-time

Job function : Health Care Provider

Industries : Medical Equipment Manufacturing

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