Specialist, Medical Writing

Edwards Lifesciences • Frankfort, KY • 3d ago

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Specialist, Medical Writing, Surgical-Regulatory Affairs will be responsible for supporting the development of clinical evaluation and post-market clinical follow-up documents under EU Medical Device Regulation (EU MDR).

How you will make an impact:

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

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

Conduct literature searches and reviews including developing search strategy, manage associated documentation, and prepare literature summaries

Provide input on other moderately complex cross-functional deliverables (e.g., risk management review, IFUs, SSCP) utilizing technical knowledge

Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing

What you will need (Required):

Bachelor's Degree in related field, 3 years' of previous related experience in medical writing or equivalent work experience based on Edwards criteria

Willingness to travel on-site once per quarter to meet with the larger team.

What else we look for (Preferred):

Advanced Degree (Master's or PhD with experience working in a regulated industry or academia)

Experience in scientific writing such as authoring publications, manuscripts, and research grants

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

Experience in preparing domestic and international product submissions

Proven understanding of anatomy, physiology, and how to interpret data and summarize data in the cardiovascular space

Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel

Excellent written and verbal communication skills and interpersonal relationship skills

Strong problem-solving, organizational, analytical and critical thinking skills

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

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 base pay range for this position is $87,000 - $123,000 in tool (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., geographic location, 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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