Medical Writing Specialist, Advanced Technology (Remote, USA)

Join us to incubate and explore world-class innovations in Structural Heart Disease to substantially improve patient outcomes.This is an outstanding opportunity to join an early-stage product development group. Edwards Advanced Technology is passionate about developing solutions for patients suffering from structural heart disease. We are seeking a talented and agile regulatory professional to join this fast-paced, dynamic team and play a central role in the development of new therapies and devices, from concept though early human-use and pivotal trials.The Specialist of Medical Writing will develop robust clinical, scientific, and regulatory documents for regulatory submissions, reports and responses, and internal and external meetings.Key Responsibilities:Write moderately complex clinical documents for regional regulatory submissions, may include, but not limited to: annual progress reports, clinical experience summaries, interim and final clinical study reports for the assigned projects. May assist Clinical Safety Team with clinical narratives

Research, create, and edit moderately complex scientific documents and presentations of clinical research based on input from the Clinical team, Key Opinion Leaders (KOLs), and physician investigators or contribute to/edit safety reports, benefit risk assessments, protocols, statistical analysis plans and case report forms

Project Lead for medical writing deliverables for assigned clinical studies. This may entail serving as the primary cross-functional contact, negotiating deliverable timelines, and resolving project-related issues

Conduct literature searches, managing the literature database and prepare literature reviews for internal and cross-functional team members

Provide guidance to the clinical team in development of clinical and regulatory reporting plans

Review draft publications for accuracy and continuity with previously submitted regulatory documents

Other incidental duties

Education and Experience:Bachelor's Degree in in related field, 5 years years experience of related scientific experience Required or

Master's Degree or equivalent in or Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in related field, 3 years years experience of related scientific experience Required

Other:Experience as a medical writer for pharmaceutical, Contract Research Organization (CRO), or medical device clients Preferred

Experience as an author or contributor for peer-reviewed manuscripts Preferred

Additional Skills:Good editing and prooing skills

Moderate knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)

Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)

Good written and verbal communication skills;

Good problem-solving 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 of statistics

Strict attention to detail

Ability to interact professionally with all organizational levels and functions where appropriate

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

Develops solutions to a variety of problems of moderate scope and complexity

Contributes to process improvements

For Colorado Residents Only: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 $80,000 to $93,000Additional information can be found through the link below:https://www.edwards.com/careers/benefitsEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.