Specialist, Medical Writing, Clinical Affairs - Edwards Lifesciences
Dover, DE
About the Job
Imagine how your ideas and expertise can change a patient’s life. The Clinical Affairs team generates 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.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
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, SSED) utilizing technical knowledge
+ Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing
+ Other incidental duties assigned by Leadership
What you’ll need (Required):
+ Bachelor's Degree in related field with 3 years of related experience in medical writing
OR
+ Master’s Degree in related field
What else we look for (Preferred):
+ Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
+ Good written and verbal communication skills and interpersonal relationship skills
+ Good problem-solving, organizational, analytical and critical thinking skills
+ Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
+ Moderate knowledge and understanding of policies, procedures and guidelines related to the development of scientific content
+ Moderate knowledge of medical writing
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast-paced environment
+ 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 $83,000 to $117,000 (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.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
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, SSED) utilizing technical knowledge
+ Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing
+ Other incidental duties assigned by Leadership
What you’ll need (Required):
+ Bachelor's Degree in related field with 3 years of related experience in medical writing
OR
+ Master’s Degree in related field
What else we look for (Preferred):
+ Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
+ Good written and verbal communication skills and interpersonal relationship skills
+ Good problem-solving, organizational, analytical and critical thinking skills
+ Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
+ Moderate knowledge and understanding of policies, procedures and guidelines related to the development of scientific content
+ Moderate knowledge of medical writing
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast-paced environment
+ 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 $83,000 to $117,000 (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.
Source : Edwards Lifesciences