Specialist, Medical Writing Job at Edwards Lifesciences in San Diego

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.

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. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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