Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.

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 Specialist, Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. The Specialist should have 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, contribute to the development of search terms and criteria, extract relevant clinical data, and write clear and concise summaries of the data to support the clinical evaluation and clinical study reports

• Prepare moderately complex medical writing documents/deliverables for assigned project(s)

• 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 3 years of experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR

• Master's degree in a related field with 1 year experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR

• Doctorate degree (PhD, MD, PharmD) with relevant postdoctoral fellowship or graduate research experience.

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, current mitral and tricuspid treatment landscape, and relevant clinical research/trials.

• 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.

Additional skills and general expectations:

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

• Excellent oral and written communication skills

• Experienced in keeping up-to-date with product developments, clinical literature, and therapeutic knowledge, and operational 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.

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.

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 $85,000 to $120,000 (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.