Edwards' has an exciting opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally invasive solutions for patients suffering from structural heart disease. This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology.
As the Senior Specialist, Medical Writer supporting the THV division, you will serve as a medical writer working with subject matter experts to create abstracts, manuscripts, and presentations that effectively and clearly describe clinical trial methodology, data, product use, and relevance. You will ensure that publications and presentations comply with Quality Systems Regulations and applicable regulatory, journal, and other guidelines in terms of content, format, and structure.
Ensure timely and successful development of high-quality manuscripts, abstracts, and posters, including medical writing, editing, finalizing, and submitting content to scientific congresses and medical journals, to support Edwards Lifesciences' transcatheter heart valve scientific communication plan.
Work collaboratively with study investigators to develop manuscripts, podium presentations, and posters for publication or presentation at interventional cardiology and cardiothoracic surgery conferences.
Comply with Quality System Regulations and relevant guidelines for scientific publications, including but not limited to ICMJE and GPP3.
Work collaboratively with cross-functional teams, including regulatory, research and development, biostatistics, clinical safety, and marketing to achieve publication and communication goals.
Participate in clinical trial core team meetings, providing clear and timely communication to cross-functional partners about clinical trial-specific publication and podium plans.
Work collaboratively with clinical research teams, including data mining, compiling, analyzing, and summarizing data for primary and secondary publication and podium projects.
Bachelor's Degree with 5 years years of professional medical writing experience including clinical data analysis, publication development, and publication project management or Master's degree with 3 years of experience
Expert knowledge of MS Word, Excel, and PowerPoint.
Experience working in a cross functional, collaborative environment and is comfortable interacting with R&D engineers, regulatory specialists, physicians, biostatisticians, project managers, marketing professionals and support personnel
Overnight travel across the US and internationally for professional meetings is required. Travel is estimated to be 25% (post-COVID and/or adhering to COVID guidelines)
Understanding and knowledge of interventional cardiology (coronary or structural heart) or have expert clinical experience or clinical trial experience that fulfills this requirement.
Expert understanding and application of GPP3 requirements, ICMJE recommendations, ICH guidelines, and Quality Systems Regulations
Expert ability to conduct PubMed literature searches
Ability to comprehend high-level scientific documentation including statistical tables, biostatistical analysis and medical literature
Excellent written, oral, and presentation skills.
Medical Writer Certification or Credential (e.g. ELS or CMPP)
Additional Talents and General Expectations:
Excellent problem-solving, organizational, analytical and critical thinking skills
Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content
Ability to manage competing priorities in a fast paced environment
Maintain current, in-depth product knowledge, including current developments, clinical literature, and therapeutic and product usage knowledge.
Track projects and provide project-related updates to internal and external customers.
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 $99,000 to $116,000
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences Corp